Breast CancerPhase 2NCT00451555

Enzastaurin Plus Fulvestrant vs. Placebo Plus Fulvestrant in Breast Cancer

A Phase 2 study testing enzastaurin and fulvestrant in people with Breast Cancer, run by Eli Lilly and Company at 21 sites in 5 countries.

Completed

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

Official record

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Trial summary

The primary purpose of this study is to help answer the following research question: whether enzastaurin given together with fulvestrant can help participants who have breast cancer and make the tumor smaller or disappear and for how long. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: enzastaurin and fulvestrant
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 156 participants
Where: 21 sitesin 5 countries
Study dates: 11 Apr 2007to 18 Oct 2018
Phase: Phase 2
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
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female participants with a histological-documented diagnosis of locally advanced or metastatic breast cancer. The primary or metastatic tumor must be estrogen response (ER) and/or parathyroid hormone receptor (PtR) positive.
Note: Hormone receptor positivity is defined as ER or PtR greater than 10 fmol/mg by biochemical assay or 10% positive cells by immunohistochemistry
Participants are resistant to aromatase inhibitors (AI) therapy
Females with postmenopausal status
Previous radiation therapy is allowed, but should have been limited
Measurable or non-measurable disease

Show all 10Show fewer

Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) scale
Have adequate organ function
Have an estimated life expectancy of at least 24 weeks
Must sign an informed consent document

Who cannot join

Have had prior treatment with fulvestrant or enzastaurin
Are receiving concurrent administration of any other antitumor therapy, with the exception of gonadotropin-releasing hormone (GnRH) antagonists.
Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry
Have received supplemental estrogen or progesterone within 4 weeks prior to study entry
Are hormone estrogen receptor (HER2)-positive
Are unable to discontinue use of anticoagulants

Show all 13Show fewer

Have hypercalcemia
Have a second primary malignancy that is clinically detectable at the time of consideration for study enrollment
Have documented central nervous system (CNS) metastases, symptomatic pulmonary lymphangitis, or involvement of more than 1/3 of the liver
Have a serious concomitant systemic disorder
Have a serious cardiac condition
Are unwilling or unable to discontinue use of carbamazepine, phenobarbital, or phenytoin at least 14 days prior to study therapy
Are unable to swallow tablets.

Trial locations and contacts

21 sites in 5 countries.

Country

City, postcode or hospital

21 sites in 5 countries

Germany5 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Bielefeld, 33604
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dresden, 01127
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Gütersloh, 33332
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Kiel, D-24105
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Mannheim, 68161

Other trials in Germany

France4 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Besançon, 25030
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Paris, 75231
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Saint-Herblain, 44805
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Toulouse, 31052

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Italy4 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Meldola, 47014
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Milan, 20133
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Modena, 41100
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Rome, 00144

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Netherlands4 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Amsterdam, 1066 CX
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Groningen, 9728 NT
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Maastricht, 6229 HX
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
The Hague, 2545 CH

Other trials in Netherlands

Spain4 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona, 08036
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Lleida, 25198
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madrid, 28033
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Valencia, 46010

Other trials in Spain

About this study

Official title: A Randomized, Double-Blind, Phase II Trial of Fulvestrant Plus Enzastaurin Versus Fulvestrant Plus Placebo in Aromatase Inhibitor-Resistant Metastatic Breast Cancer

Conditions: Breast Cancer
Being tested: enzastaurin, placebo, fulvestrant
Medical subject headings: Breast Neoplasms

What participants receive

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

enzastaurinDrug
Also called LY317615
1125 milligram (mg) loading dose then 250 mg, oral, twice daily (for a total of 500 mg), until disease progression
placeboDrug
oral, daily
fulvestrantDrug
500 mg, intramuscular (IM), day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression

Study groups in NCT00451555
Study group	Role	What they receive
Enzastaurin + Fulvestrant	Experimental	Participants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle. Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter. Receives: Drug: enzastaurin; Drug: fulvestrant
Fulvestrant + Placebo	Placebo comparator	Participants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily. Receives: Drug: placebo; Drug: fulvestrant

What is being measured

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

Percentage of Participants Who Achieved a Best Response of Complete Response, Partial Response, and Stable Disease (CR+PR+SD) (Clinical Benefit Rate)
Clinical benefit rate is defined as the rate of confirmed CR, confirmed PR, and SD for 24 weeks duration and is the best response CR, PR, or SD as classified by the investigators according to the RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Kaplan-Meier (KM) techniques were used to assess the time-to-event endpoints. Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir.
Measured: Baseline to Measured Progressive Disease or Study Discontinuation (Up to 24 Weeks)

Secondary outcomes (5)

Percentage of Participants Achieving Overall Tumor Response Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR])
The ORR is equal to the percentage of participants achieving a best overall response of partial response or complete response (PR + CR), according to RECIST version 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes must have reduction in short axis to <10 millimeter (mm) and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions; PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir; SD was defined as small changes that did not meet above criteria. Participants who had no post baseline tumor assessments were considered non-responders and included in the denominator when calculating response rate. The 95% confidence interval (CI) was calculated by exact method. Kaplan-Meier (KM) techniques were used to assess the time-to-event endpoints.
Measured: Baseline to Measured Progressive Disease or Study Discontinuation (Up to 24 Weeks)
Duration of Clinical Benefit
The duration of clinical benefit was measured from the time of clinical benefit of CR, PR or SD to the time of progressive disease or death from any cause. PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir. Kaplan-Meier (KM) techniques were used to assess the time-to-event endpoints.
Measured: Time of Clinical Benefit to Progressive Disease or Death (Up to 3 Years)
Progression Free Survival (PFS)
Progression-free survival (PFS) time was defined as the time from baseline to the first date of progressive disease (symptomatic or objective) or death due to any cause, whichever occurred first. PD was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir.For participants who were not known to have died or progressed as of the data-inclusion cutoff date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy. PFS was summarized using Kaplan-Meier estimates.
Measured: Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 3 Years)
Number of Participants Who Discontinued With Adverse Events (AE) and Serious Adverse Events (SAEs)
Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs, regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. Participants who discontinued due to an AE or SAE are reported.
Measured: From Baseline to Study Completion (Up to 3 years, 9 months)
Percentage of Participants With Enzastaurin Biomarkers and Disease State
Measured: Baseline, Cycle 2 to Study Completion (Up to 3 Years, 9 Months)

Timeline

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

11 Apr 200718 Oct 2018

First posted23 Mar 2007 (estimated)
Study start11 Apr 2007
Primary completion28 Dec 2010
Study completion18 Oct 2018

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 Breast CancerStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00451555
Sponsor's protocol ID: 10736
Other IDs: H6Q-MC-S023
Status last verified: 1 Nov 2018
First submitted: 21 Mar 2007
Last updated: 1 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Phase II Trial of Fulvestrant Plus Enzastaurin Versus Fulvestrant Plus Placebo in Aromatase Inhibitor-Resistant Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT00451555
Acronym / sponsor ID: 10736
Conditions: Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 156 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 11 Apr 2007 (actual)
Primary completion: 28 Dec 2010 (actual)
Study completion: 18 Oct 2018 (actual)
First posted: 23 Mar 2007 (estimated)
Results: Posted 1 Nov 2019

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Enzastaurin + Fulvestrant	Experimental	Drug: enzastaurin, Drug: fulvestrantParticipants received Enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 500 mg orally (QD) once daily in a 28-day cycle. Participants received enzastaurin loading dose of 1125 mg, on Day 1 of Cycle 1 only then received Enzastaurin 250 mg orally (BID) twice daily in a 28-day cycle. Fulvestrant was given intramuscularly at a loading dose of 500 mg on Day 1 and 250 mg on Day 15 in Cycle 1. Subsequent doses of Fulvestrant 250 mg were given on Day 1 of Cycle 2 and every 28 days thereafter.
Fulvestrant + Placebo	Placebo comparator	Drug: placebo, Drug: fulvestrantParticipants received fulvestrant: 500 mg, IM, day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression. Then, participants received placebo, oral, daily.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Female participants with a histological-documented diagnosis of locally advanced or metastatic breast cancer. The primary or metastatic tumor must be estrogen response (ER) and/or parathyroid hormone receptor (PtR) positive.
Note: Hormone receptor positivity is defined as ER or PtR greater than 10 fmol/mg by biochemical assay or 10% positive cells by immunohistochemistry
Participants are resistant to aromatase inhibitors (AI) therapy
Females with postmenopausal status
Previous radiation therapy is allowed, but should have been limited

Key exclusion criteria (13 listed)

Have had prior treatment with fulvestrant or enzastaurin
Are receiving concurrent administration of any other antitumor therapy, with the exception of gonadotropin-releasing hormone (GnRH) antagonists.
Have received treatment within the last 4 weeks with a drug that has not received regulatory approval for any indication at the time of study entry
Have received supplemental estrogen or progesterone within 4 weeks prior to study entry
Are hormone estrogen receptor (HER2)-positive

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
enzastaurinAlso: LY3176151125 milligram (mg) loading dose then 250 mg, oral, twice daily (for a total of 500 mg), until disease progression	Drug	Enzastaurin + Fulvestrant
placebooral, daily	Drug	Fulvestrant + Placebo
fulvestrant500 mg, intramuscular (IM), day 1, 1250 mg, IM, day 15 cycle 1 then 250 mg, IM, every 28 days, until disease progression	Drug	Enzastaurin + Fulvestrant, Fulvestrant + Placebo

Primary outcome

Percentage of Participants Who Achieved a Best Response of Complete Response, Partial Response, and Stable Disease (CR+PR+SD) (Clinical Benefit Rate)
Time frame: Baseline to Measured Progressive Disease or Study Discontinuation (Up to 24 Weeks)
Clinical benefit rate is defined as the rate of confirmed CR, confirmed PR, and SD for 24 weeks duration and is the best response CR, PR, or SD as classified by the investigators according to the RECIST v1.1. CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started. Kaplan-Meier (KM) techniques were used to assess the time-to-event endpoints. Progressive Disease (PD) was defined as having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir.

5 secondary outcomes

Percentage of Participants Achieving Overall Tumor Response Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR])
Time frame: Baseline to Measured Progressive Disease or Study Discontinuation (Up to 24 Weeks)
Duration of Clinical Benefit
Time frame: Time of Clinical Benefit to Progressive Disease or Death (Up to 3 Years)
Progression Free Survival (PFS)
Time frame: Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 3 Years)
Number of Participants Who Discontinued With Adverse Events (AE) and Serious Adverse Events (SAEs)
Time frame: From Baseline to Study Completion (Up to 3 years, 9 months)
Percentage of Participants With Enzastaurin Biomarkers and Disease State
Time frame: Baseline, Cycle 2 to Study Completion (Up to 3 Years, 9 Months)

Results and safety

Results posted to the registry on 1 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enzastaurin + Fulvestrant	96	83
Fulvestrant + Placebo	60	56

Primary outcome: Percentage of Participants Who Achieved a Best Response of Complete Response, Partial Response, and Stable Disease (CR+PR+SD) (Clinical Benefit Rate)

Time frame: Baseline to Measured Progressive Disease or Study Discontinuation (Up to 24 Weeks). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Enzastaurin + Fulvestrant QD + BID n = 94	Enzastaurin + Fulvestrant BID n = 39	Enzastaurin + Fulvestrant QD n = 55	Fulvestrant + Placebo n = 58
Value	43.6 (33.4 to 54.2)	43.6 (27.8 to 60.4)	43.6 (30.3 to 57.7)	44.8 (31.7 to 58.5)

Enzastaurin + Fulvestrant QD + BID vs Fulvestrant + Placebo: p = 0.6238, Fisher Exact
Enzastaurin + Fulvestrant BID vs Fulvestrant + Placebo: p = 0.6282, Fisher Exact
Enzastaurin + Fulvestrant QD vs Fulvestrant + Placebo: p = 0.6242, Fisher Exact

Population analysed: All randomized participants who received at least one dose of study drug.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline to Study Completion (Up to 3 Years, 9 Months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fulvestrant + Enzastaurin (QD + BID)	17 of 94 (18.1%)	78 of 94 (83%)	Not reported
Fulvestrant + Enzastuarin (QD)	9 of 39 (23.1%)	31 of 39 (79.5%)	Not reported
Fulvestrant + Enzastuarin (BID)	8 of 55 (14.5%)	47 of 55 (85.5%)	Not reported
Fulvestrant + Placebo	11 of 58 (19%)	50 of 58 (86.2%)	Not reported

Limitations and caveats (from the sponsor): The translational research component of the study was cancelled due to lack of efficacy in the experimental arm. Due to an amendment to the initial therapy, 250 mg BID dosing was added to the design of the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

21 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing enzastaurin and fulvestrant in people with Breast Cancer, run by Eli Lilly and Company at 21 sites in 5 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 10 inclusion and 13 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany, France, Italy, Netherlands, Spain. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 1 Nov 2019). 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 Who Achieved a Best Response of Complete Response, Partial Response, and Stable Disease (CR+PR+SD) (Clinical Benefit Rate) (time frame: Baseline to Measured Progressive Disease or Study Discontinuation (Up to 24 Weeks)). 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 NCT00451555.

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 1 Nov 2019.