Chemotherapy Induced AnemiaPhase 2NCT00272662
Study of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy
A Phase 2 study testing peginesatide in people with Chemotherapy Induced Anemia and Cancer, run by Affymax at 10 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneously administered injections of peginesatide in anemic cancer participants receiving chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chemotherapy Induced Anemia, Cancer
- What is being tested?
- peginesatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jan 2006to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines
- Males or females ≥ 18 and ≤ 80 years of age; pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 2 weeks prior to study start, and must be willing to continue practicing birth control for at least 4 weeks after the last dose of study drug. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence (only acceptable if practiced as a life-style and not acceptable if one who is sexually active practices abstinence only for the duration of study) or vasectomized partner
- Participants with histologically confirmed solid tumor malignancy or lymphoma who are scheduled to receive at least 9 weeks of cyclic myelosuppressive chemotherapy while on study
- Hemoglobin value of ≥ 8 and < 11 g/dL within 1 week prior to administration of study drug.
- ECOG Performance Status of 0-2
- One reticulocyte hemoglobin content (CHr) > 29 picograms within 4 weeks prior to study drug administration.
Show all 12Show fewer
- One transferrin saturation ≥ 15% within 4 weeks prior to study drug administration.
- One serum or red cell folate level above the lower limit of normal within 4 weeks prior to study drug administration
- One vitamin B12 level above the lower limit of normal within 4 weeks prior to study drug administration
- One absolute neutrophil count ≥ 1.0 x 10^9/L within 1 week prior to administration of study drug
- One platelet count ≥ 75 x 10^9/L within 1 week prior to administration of study drug
- Life expectancy > 6 months.
Who cannot join
- Treatment with any erythropoiesis stimulating agent (ESA) in the past 90 days
- History of failure to respond to ESA treatment
- Known antibodies to other ESAs or history of pure red cell aplasia (PRCA)
- Acute or chronic leukemia, myelodysplastic syndrome (MDS), or multiple myeloma
- Any previous or planned radiotherapy to more than 50% of either the pelvis or spine
- Known intolerance to parenteral iron supplementation
Show all 23Show fewer
- Red blood cell transfusion within 4 weeks prior to study drug administration
- Known hemoglobinopathy (e.g., homozygous sickle-cell disease, thalassemia of all types, etc.)
- Known hemolysis
- History of pulmonary embolism or deep venous thrombosis (DVT) in the previous 2 years or current therapeutic doses of anticoagulants
- Known blood loss as a cause of anemia
- Uncontrolled, or symptomatic inflammatory disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 times the upper limit of normal; AST or ALT > 5 times the upper limit of normal if liver metastases are present.
- Creatinine > 175 micromoles per liter (µmol/L)
- History of bone marrow or peripheral blood cell transplantation
- Pyrexia/fever of ≥ 39 °C within 48 hours prior to study drug administration
- Poorly controlled hypertension, per the Investigator's judgment, within 4 weeks prior to study drug administration (e.g., systolic ≥ 170 mm Hg or diastolic ≥ 100 mm Hg on repeat readings)
- Epileptic seizure in the 6 months prior to study drug administration
- Advanced chronic congestive heart failure - New York Heart Association Class IV
- High likelihood of early withdrawal or interruption of the study
- Anticipated elective surgery during the study period
- History of multiple drug allergies
- Exposure to any investigational agent within 1 month prior to administration of study drug or planned receipt during the study period.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
Poland5 sites
Research Facility
Gdansk
Research Facilities
Krakow
Research Facility
Lodz
Research Facility
Poznan
Research Facility
Szczecin
Czechia4 sites
Research Facilities
Brno
Research Facility
Hradec Králové
Research Facility
Olomouc
Research Facility
Příbram
About this study
Official title: A Phase 2, Open-Label, Multi-Center Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneously administered injections of peginesatide in anemic cancer participants receiving chemotherapy.
Read the detailed description
This was a Phase 2, open-label, multi-center, sequential dose finding study with up to 6 treatment cohorts receiving chemotherapy with 15 participants per cohort. The primary objective of this study was to determine the dose of peginesatide administered every 3 weeks (Q3W) by subcutaneous injection associated with a hemoglobin increase of ≥ 1 g/dL in ≥ 50% of anemic cancer participants receiving chemotherapy at 9 weeks following the first dose.
- Conditions
- Chemotherapy Induced Anemia, Cancer
- Being tested
- peginesatide
- Keywords
- anemia, cancer, chemotherapy, chemotherapy induced anemia, CIA, hemoglobin, Hb, Hgb, erythropoietin, EPO, erythropoiesis stimulating agent, ESA, Hematide, Omontys, peginesatide, red blood cell, red blood cell production
- Medical subject headings
- Neoplasms, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peginesatideDrug
Also called Omontys, Hematide, AF37702 Injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Peginesatide starting dose of 0.1 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 3 weeks (Q3W) for a total of 4 doses. Receives: Drug: peginesatide |
| Cohort 2 | Experimental | Peginesatide starting dose of 0.15 mg/kg administered SC Q3W for a total of 4 doses. Receives: Drug: peginesatide |
| Cohort 3 | Experimental | Peginesatide starting dose of 0.2 mg/kg administered SC Q3W for a total of 4 doses. Receives: Drug: peginesatide |
| Cohort 4 | Experimental | Peginesatide starting dose of 0.05 mg/kg administered SC Q3W for a total of 4 doses. Receives: Drug: peginesatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with a hemoglobin increase of ≥ 1 gram per deciliter (g/dL) at 9 weeks following Dose 1
Measured: Week 9 post Dose 1
Secondary outcomes (4)
Incidence of adverse events and serious adverse events
Measured: 13 Weeks
Time to achieve hemoglobin increase ≥ 1 g/dL from baseline
Measured: Baseline to Week 13
Proportion of participants with a hemoglobin response
Measured: 13 Weeks
Pharmacokinetic parameters
Measured: 13 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startJan 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced AnemiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affymax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Affymax, Study director, Affymax, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00272662
- Sponsor's protocol ID
- AFX01-05
- Other IDs
- 2005-003354-10, 2005
- Status last verified
- Dec 2012
- First submitted
- 5 Jan 2006
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label, Multi-Center Dose Escalation Study of the Safety, Pharmacodynamics, and Pharmacokinetics of Subcutaneously Administered Peginesatide in Anemic Cancer Patients Receiving Chemotherapy
- ClinicalTrials.gov ID
- NCT00272662
- Acronym / sponsor ID
- AFX01-05
- Conditions
- Chemotherapy Induced Anemia, Cancer
- Keywords
- anemia, cancer, chemotherapy, chemotherapy induced anemia, CIA, hemoglobin, Hb, Hgb
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AffymaxIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, pharmacodynamics (PD), and pharmacokinetics (PK) of multiple subcutaneously administered injections of peginesatide in anemic cancer participants receiving chemotherapy.
Detailed description
This was a Phase 2, open-label, multi-center, sequential dose finding study with up to 6 treatment cohorts receiving chemotherapy with 15 participants per cohort. The primary objective of this study was to determine the dose of peginesatide administered every 3 weeks (Q3W) by subcutaneous injection associated with a hemoglobin increase of ≥ 1 g/dL in ≥ 50% of anemic cancer participants receiving chemotherapy at 9 weeks following the first dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: peginesatidePeginesatide starting dose of 0.1 milligram per kilogram (mg/kg) administered subcutaneously (SC) once every 3 weeks (Q3W) for a total of 4 doses. |
| Cohort 2 | Experimental | Drug: peginesatidePeginesatide starting dose of 0.15 mg/kg administered SC Q3W for a total of 4 doses. |
| Cohort 3 | Experimental | Drug: peginesatidePeginesatide starting dose of 0.2 mg/kg administered SC Q3W for a total of 4 doses. |
| Cohort 4 | Experimental | Drug: peginesatidePeginesatide starting dose of 0.05 mg/kg administered SC Q3W for a total of 4 doses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participant is informed of the investigational nature of this study and has given written, witnessed informed consent in accordance with institutional, local, and national guidelines
- Males or females ≥ 18 and ≤ 80 years of age; pre-menopausal females (with the exception of those who are surgically sterile) must have a negative pregnancy test at screening; those who are sexually active must practice a highly effective method of birth control for at least 2 weeks prior to study start, and must be willing to continue practicing birth control for at least 4 weeks after the last dose of study drug. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence (only acceptable if practiced as a life-style and not acceptable if one who is sexually active practices abstinence only for the duration of study) or vasectomized partner
- Participants with histologically confirmed solid tumor malignancy or lymphoma who are scheduled to receive at least 9 weeks of cyclic myelosuppressive chemotherapy while on study
- Hemoglobin value of ≥ 8 and < 11 g/dL within 1 week prior to administration of study drug.
- ECOG Performance Status of 0-2
Key exclusion criteria (23 listed)
- Treatment with any erythropoiesis stimulating agent (ESA) in the past 90 days
- History of failure to respond to ESA treatment
- Known antibodies to other ESAs or history of pure red cell aplasia (PRCA)
- Acute or chronic leukemia, myelodysplastic syndrome (MDS), or multiple myeloma
- Any previous or planned radiotherapy to more than 50% of either the pelvis or spine
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 |
|---|---|---|
| peginesatideAlso: Omontys, Hematide, AF37702 Injection | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Percentage of participants with a hemoglobin increase of ≥ 1 gram per deciliter (g/dL) at 9 weeks following Dose 1
Time frame: Week 9 post Dose 1
4 secondary outcomes
Incidence of adverse events and serious adverse events
Time frame: 13 Weeks
Time to achieve hemoglobin increase ≥ 1 g/dL from baseline
Time frame: Baseline to Week 13
Proportion of participants with a hemoglobin response
Time frame: 13 Weeks
Pharmacokinetic parameters
Time frame: 13 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
Related trials for Chemotherapy Induced Anemia
Not yet recruitingPhase 2
HEC53856 Tablets for Chemotherapy-induced Anemia in Non-myeloid Malignancies
Chemotherapy-induced Anemia, Non-Myeloid Malignancy
Active, not recruitingPhase 4
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan
Extensive-stage Small-cell Lung Cancer
Not yet recruitingPhase 2
A Study of AND017 in Cancer Related Anemic Patients Receiving Chemotherapy
Chemotherapy Induced Anemia
RecruitingPhase 1/2
Luspatercept for CIA in AML
Chemotherapy-inducing Anemia
RecruitingObservational study
Home Monitoring of Complete Blood Count Performed by Patients - a Pilot Study on the Implementation Process in South Baltic Countries.
Cancer, Cancer-related Problem/Condition
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.
Affymax study director
Affymax, Inc
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing peginesatide in people with Chemotherapy Induced Anemia and Cancer, run by Affymax at 10 sites in 3 countries.
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 12 inclusion and 23 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 21 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Poland, Czechia, United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 a hemoglobin increase of ≥ 1 gram per deciliter (g/dL) at 9 weeks following Dose 1 (time frame: Week 9 post Dose 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2012.