Anemia, NeoplasmsNCT01168349

An Observational Study of NeoRecormon (Epoetin Beta) in Cancer Patients With Anemia (FAST)

An observational study of Anemia, Neoplasms, run by Hoffmann-La Roche at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This observational study will evaluate the clinical benefit of NeoRecormon (epoetin beta) in daily routine practice in cancer patients with anemia. Data will be collected from patients who are receiving chemotherapy for a solid tumor or hematological malignancy. Patients will be followed for 28 weeks. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anemia, Neoplasms
What is being tested?: epoetin beta [NeoRecormon]
How many people: 1,060 participants
Where: 1 siteFrance
Study dates: Jan 2010to Dec 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Anemic cancer patients receiving NeoRecormon (epoetin beta)

Who may be able to join

Adult patients, >/=18 years of age
Patients receiving myelosuppressive chemotherapy for a solid tumor, a hematological malignancy or an autograft for hematological malignancy
Patients for whom treatment with epoetin beta is started at the inclusion visit
Life expectancy >/=6 months according to the physician
Patients accepting and able to complete a French written questionnaire about his/her professional and social activities at each visit

Who cannot join

Patients who received erythropoiesis-stimulating agents treatment, or red blood cell transfusion within 4 weeks before enrollment
Participation in a clinical trial in onco-hematology
Patients with myelodysplasia
Patients with more than one active malignancy at the time of enrollment

Trial locations and contacts

1 site in 1 country.

France1 site

Study site
Neuilly-sur-Seine, 92521

Other trials in France

About this study

Official title: Pharmaco-epidemiological Observational Study of the Clinical Benefit of NeoRecormon® in Cancer Patients With Anemia, According to Early Response to Treatment

Conditions: Anemia, Neoplasms
Being tested: epoetin beta [NeoRecormon]
Medical subject headings: Anemia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

epoetin beta [NeoRecormon]Drug
As prescribed by physician

Study groups in NCT01168349
Study group	Role	What they receive
Cohort		Not described Receives: Drug: epoetin beta [NeoRecormon]

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Early Treatment Response: Day 28 to 42
Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation.
Measured: Day 28 to 42
Percentage of Participants With Early Treatment Response: Day 21 to 42
Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
Measured: Day 21 to 42
Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion
Participants with at least 1 RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
Measured: Baseline up to Week 28
Mean Number of RBC Transfusions
Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion.
Measured: Baseline up to Week 28
Mean Number of RBC Units
Mean number of units was based on the number of participants with at least 1 RBC transfusion.
Measured: Baseline up to Week 28
Time to First RBC Transfusions
Time to first RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. Kaplan-Meier estimate was used.
Measured: Baseline up to Week 28
Karnofsky Performance Status (KPS): Baseline
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
Measured: Baseline
KPS: Week 4 to 6
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
Measured: Week 4 to 6
KPS: Week 12 to 16
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
Measured: Week 12 to 16
KPS: Week 24 to 28
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
Measured: Week 24 to 28
Percentage of Participants With Professional Activity: Baseline
Percentage of participants with professional activity was assessed based on the number of participants with early response or not at Day 21 to 42. Professional activity was categorized as active; disability; no occupation; retired; sick leave; student, training; and unemployment.
Measured: Baseline
Percentage of Participants With At Least 1 Sick Leave
Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).
Measured: Week 4 Up to Week 28
Mean Number of Days of Sick Leave
Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).
Measured: Week 4 Up to Week 28
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline
Self-administered questionnaire, work productivity and activity impairment (WPAI) questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Measured: Baseline
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Measured: Week 4 to 6
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Measured: Week 12 to 16
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Measured: Week 24 to 28
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).
Measured: Baseline, Week 4 to 6
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).
Measured: Baseline, Week 12 to 16
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).
Measured: Baseline, Week 24 to 28

Secondary outcomes (12)

Mean Starting Dose of NeoRecormon® Injection
Dose of NeoRecormon® injection was measured in international units/kilograms/weeks (IU/kg/weeks).
Measured: Baseline
Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks
Measured: Baseline
Percentage of Participants With Pre-specified Dose and Frequency of Injections
Pre-specified doses and frequency included; 20000 IU/week - Once a week (qw), 30000 IU/week -qw, 30000 IU/week - Twice a week (tw), 30000 IU/week - Once every 2 weeks (q2w), 40000 IU/week - qw, 60000 IU/week - qw, and other. Missing data were not reported.
Measured: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48
Percentage of Participants With Subcutaneous (SC) Route of Administration
Measured: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48
Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU
Measured: Baseline up to Week 28
Percentage of Participants With Modifications of NeoRecormon® Regimen
All modifications were based on the change in frequency, route of administration or dose depending on the need for treatment adjustments according to Hb concentration. Percentage of participants with at least 1 modification in NeoRecormon® regimen was reported.
Measured: Baseline up to Week 28
Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment
Percentage of participants with at least 1 temporary discontinuation was reported.
Measured: Baseline up to Week 28
Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment
Measured: Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28
Relative Percent Change in Hb Concentration From Baseline Over the Study Period
Measured: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28
Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL
Measured: Baseline up to Week 28
Percentage of Participants With Adequate Iron Status
Criteria for adequate iron status included serum ferritin greater than (>) 100 micrograms/liter (µg/L) and transferrin saturation (TSAT)> 20%.
Measured: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48
Percentage of Participants With Vitamins Prescription
Measured: Week 4 to 6, Week 12 to 16, Week 24 to 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Dec 2010

First posted23 Jul 2010 (estimated)
Study startJan 2010
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anemia, NeoplasmsStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,060 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01168349
Sponsor's protocol ID: ML22733
Status last verified: Sep 2015
First submitted: 21 Jul 2010
Last updated: 2 Oct 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Anemia, Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmaco-epidemiological Observational Study of the Clinical Benefit of NeoRecormon® in Cancer Patients With Anemia, According to Early Response to Treatment
ClinicalTrials.gov ID: NCT01168349
Acronym / sponsor ID: ML22733
Conditions: Anemia, Neoplasms
Study type: Observational
Recruitment status: Completed
Enrolment: 1,060 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 23 Jul 2010 (estimated)
Results: Posted 2 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Cohort	–	Drug: epoetin beta [NeoRecormon]

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Anemic cancer patients receiving NeoRecormon (epoetin beta)

Key inclusion criteria (5 listed)

Adult patients, >/=18 years of age
Patients receiving myelosuppressive chemotherapy for a solid tumor, a hematological malignancy or an autograft for hematological malignancy
Patients for whom treatment with epoetin beta is started at the inclusion visit
Life expectancy >/=6 months according to the physician
Patients accepting and able to complete a French written questionnaire about his/her professional and social activities at each visit

Key exclusion criteria (4 listed)

Patients who received erythropoiesis-stimulating agents treatment, or red blood cell transfusion within 4 weeks before enrollment
Participation in a clinical trial in onco-hematology
Patients with myelodysplasia
Patients with more than one active malignancy at the time of enrollment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
epoetin beta [NeoRecormon]As prescribed by physician	Drug	Cohort

Primary outcome

Percentage of Participants With Early Treatment Response: Day 28 to 42
Time frame: Day 28 to 42
Early treatment response was defined as an increase of Hemoglobin (Hb) concentration of at least 1 gram/deciliter (g/dL), 4 to 6 weeks after treatment initiation.
Percentage of Participants With Early Treatment Response: Day 21 to 42
Time frame: Day 21 to 42
Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion
Time frame: Baseline up to Week 28
Participants with at least 1 RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
Mean Number of RBC Transfusions
Time frame: Baseline up to Week 28
Mean number of transfusion was based on the number of participants with at least 1 RBC transfusion.
Mean Number of RBC Units
Time frame: Baseline up to Week 28
Mean number of units was based on the number of participants with at least 1 RBC transfusion.
Time to First RBC Transfusions
Time frame: Baseline up to Week 28
Time to first RBC transfusion was assessed based on the number of participants with early response or not at Day 21 to 42. Early treatment response was defined as an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation. Kaplan-Meier estimate was used.
Karnofsky Performance Status (KPS): Baseline
Time frame: Baseline
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
KPS: Week 4 to 6
Time frame: Week 4 to 6
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
KPS: Week 12 to 16
Time frame: Week 12 to 16
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
KPS: Week 24 to 28
Time frame: Week 24 to 28
KPS was used to quantify participant's general well-being and activities of daily life and participants were classified based on their functional impairment. An 11-level score, KPS score ranged between 0 (death) to 100 (no evidence of disease). Higher score means higher ability to perform daily tasks. KPS was based on the number of participants with early response.
Percentage of Participants With Professional Activity: Baseline
Time frame: Baseline
Percentage of participants with professional activity was assessed based on the number of participants with early response or not at Day 21 to 42. Professional activity was categorized as active; disability; no occupation; retired; sick leave; student, training; and unemployment.
Percentage of Participants With At Least 1 Sick Leave
Time frame: Week 4 Up to Week 28
Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).
Mean Number of Days of Sick Leave
Time frame: Week 4 Up to Week 28
Sick leaves was described in active participants at inclusion (professional activity: active, in sick leave or unemployed participants).
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Baseline
Time frame: Baseline
Self-administered questionnaire, work productivity and activity impairment (WPAI) questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 4 to 6
Time frame: Week 4 to 6
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 12 to 16
Time frame: Week 12 to 16
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Self-Reported Questionnaire: Percentage of Participants With Current Employment at Week 24 to 28
Time frame: Week 24 to 28
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 1 asked participants to indicate if they were currently employed or working for pay (Yes or No). Data reported for the outcome included those who were employed.
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 4 to 6
Time frame: Baseline, Week 4 to 6
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 12 to 16
Time frame: Baseline, Week 12 to 16
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).
Self-Reported Questionnaire: Change From Baseline on the Impact of Health on Regular Activities at Week 24 to 28
Time frame: Baseline, Week 24 to 28
Self-administered questionnaire, WPAI questionnaire was used to assess work and activity impairment due to anemia in cancer participants in the last 7 days. The self-administered questionnaire consisted of 6 questions. It assessed amount of absenteeism, presenteeism and daily activity impairment attributable to anemia in cancer participants. Question 6 asked participants to indicate how much their anemia affected their ability to do their regular daily activities such as housework, childcare, exercising, shopping, studying and so on, in the past 7 days on a scale from 0 (no effect) to 10 (completely prevented from doing daily activities).

12 secondary outcomes

Mean Starting Dose of NeoRecormon® Injection
Time frame: Baseline
Percentage of Participants With Starting Dose Between 360 and 540 IU/kg/Weeks
Time frame: Baseline
Percentage of Participants With Pre-specified Dose and Frequency of Injections
Time frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48
Percentage of Participants With Subcutaneous (SC) Route of Administration
Time frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48
Percentage of Participants With NeoRecormon® SC Injections at a Weekly Dose of 30000 IU
Time frame: Baseline up to Week 28
Percentage of Participants With Modifications of NeoRecormon® Regimen
Time frame: Baseline up to Week 28
Percentage of Participants With Temporary Discontinuation From NeoRecormon® Treatment
Time frame: Baseline up to Week 28
Percentage of Participants With Permanent Discontinuation From NeoRecormon® Treatment
Time frame: Baseline up to Week 4 to 6, Week 12 to 16, Week 24 to 28
Relative Percent Change in Hb Concentration From Baseline Over the Study Period
Time frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 28
Percentage of Participants With Hb Concentration Within the Range of 10 to 12 g/dL
Time frame: Baseline up to Week 28
Percentage of Participants With Adequate Iron Status
Time frame: Baseline, Week 4 to 6, Week 12 to 16, Week 24 to 48
Percentage of Participants With Vitamins Prescription
Time frame: Week 4 to 6, Week 12 to 16, Week 24 to 48

Results and safety

Results posted to the registry on 2 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anemic Cancer Participants (Total Participants)	1,055	754

Primary outcome: Percentage of Participants With Early Treatment Response: Day 28 to 42

Time frame: Day 28 to 42. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Solid Tumor Participants n = 403	Hematological Malignancy Participants n = 209	Anemic Cancer Participants (Total Participants) n = 612
Value	52.4 (47.48 to 57.23)	56.5 (49.74 to 63.18)	53.8 (49.81 to 57.71)

Population analysed: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Primary outcome: Percentage of Participants With Early Treatment Response: Day 21 to 42

Time frame: Day 21 to 42. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Solid Tumor Participants n = 519	Hematological Malignancy Participants n = 262	Anemic Cancer Participants (Total Participants) n = 781
Value	52.4 (48.11 to 56.71)	55.7 (49.71 to 61.74)	53.5 (50.02 to 57.02)

Population analysed: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Primary outcome: Percentage of Participants With At Least 1 Red Blood Cell (RBC) Transfusion

Time frame: Baseline up to Week 28. Number. Unit: percentage of participants

Measure	Responders n = 418	Non-responders n = 363	Anemic Cancer Participants (Total Participants) n = 781
Value	17.2	31.4	23.8

Responders vs Non-responders: Risk Ratio (RR): 0.55 (95% CI 0.42 to 0.71)

Population analysed: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure.

Primary outcome: Mean Number of RBC Transfusions

Time frame: Baseline up to Week 28. Mean (Standard Deviation). Unit: RBC transfusions

Measure	Responders n = 67	Non-responders n = 111	Anemic Cancer Participants (Total Participants) n = 178
Value	1.7 (1.4)	2.1 (1.9)	2.0 (1.8)

Population analysed: Efficacy population. Here "number of participants analyzed" included those participants who were evaluable for the outcome measure without any missing data.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 28 day after last dose. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Solid Tumor Participants	6 of 735 (0.8%)	63 of 735 (8.6%)	Not reported
Hematological Malignancy Participants	4 of 319 (1.3%)	31 of 319 (9.7%)	Not reported
Anemic Cancer Participants (Total Participants)	10 of 1,054 (0.9%)	94 of 1,054 (8.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Anemia, Neoplasms, run by Hoffmann-La Roche at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Early Treatment Response: Day 28 to 42 (time frame: Day 28 to 42). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01168349.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.