Small Cell Lung CarcinomaPhase 2NCT00977561
A Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing figitumumab, Cisplatin (Or Carboplatin) and Etoposide in people with Small Cell Lung Carcinoma, run by Pfizer at 51 sites in 4 countries.
Trial summary
This study will summarize the safety of patients receiving figitumumab combined with etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Carcinoma
- What is being tested?
- figitumumab, Cisplatin (Or Carboplatin) and Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 51 sitesin 4 countries
- Study dates
- Apr 2010to Oct 2011
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of extensive stage disease Small Cell Lung Cancer (SCLC), with tumor biopsy sample required.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Total IGF-1 > or = 120 ng/ml
Who cannot join
- Any prior systemic therapy for Small Cell Lung Cancer (SCLC)
- HbA1c > or = 5.7%
Trial locations and contacts
51 sites in 4 countries.
51 sites in 4 countries
United States34 sites
Pfizer Investigational Site
Beaverton, Oregon, 97006
Pfizer Investigational Site
Christiansburg, Virginia, 24074
Pfizer Investigational Site
City of Saint Peters, Missouri, 63376
Pfizer Investigational Site
Creve Coeur, Missouri, 63141
Pfizer Investigational Site
Everett, Washington, 98201
Pfizer Investigational Site
Federal Way, Washington, 98003
Pfizer Investigational Site
Gig Harbor, Washington, 98332
Pfizer Investigational Site
Gresham, Oregon, 97030
Pfizer Investigational Site
Hickory, North Carolina, 28602
Pfizer Investigational Site
Kennewick, Washington, 99336
Pfizer Investigational Site
Kernersville, North Carolina, 27284
Pfizer Investigational Site
Lakewood, Washington, 98499
Pfizer Investigational Site
Lenoir, North Carolina, 28645
Pfizer Investigational Site
Lexington, North Carolina, 27295
Pfizer Investigational Site
Low Moor, Virginia, 24457
Pfizer Investigational Site
Marrero, Louisiana, 70072
Pfizer Investigational Site
Metairie, Louisiana, 70006
Pfizer Investigational Site
Morristown, New Jersey, 07962
Pfizer Investigational Site
Mount Airy, North Carolina, 27030
Pfizer Investigational Site
North Wilkesboro, North Carolina, 28659
Pfizer Investigational Site
Portland, Oregon, 97210
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Puyallup, Washington, 98372
Pfizer Investigational Site
Roanoke, Virginia, 24014
Pfizer Investigational Site
Salem, Virginia, 24153
Pfizer Investigational Site
St Louis, Missouri, 63110-1094
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
Tacoma, Washington, 98405
Pfizer Investigational Site
Tualatin, Oregon, 97062
Pfizer Investigational Site
Washington D.C., District of Columbia, 20007-2197
Pfizer Investigational Site
Washington D.C., District of Columbia, 20007
Pfizer Investigational Site
West Reading, Pennsylvania, 19611
Pfizer Investigational Site
Winston-Salem, North Carolina, 27103
Pfizer Investigational Site
Wytheville, Virginia, 24382
Spain8 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08025
Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35016
Pfizer Investigational Site
Madrid, Madrid, 28041
Pfizer Investigational Site
Málaga, Malaga, 29010
Pfizer Investigational Site
Seville, Sevilla, 41009
Pfizer Investigational Site
Seville, Sevilla, 41013
Pfizer Investigational Site
Valencia, Valencia, 46026
Hungary5 sites
Pfizer Investigational Site
Budapest, 1125
Pfizer Investigational Site
Debrecen, 4032
Pfizer Investigational Site
Deszk, 6772
Pfizer Investigational Site
Farkasgyepű, 8582
Pfizer Investigational Site
Törökbálint, 2045
Canada4 sites
Pfizer Investigational Site
Greater Sudbury, Ontario, P3E 5J1
Pfizer Investigational Site
Lévis, Quebec, G6V 3Z1
Pfizer Investigational Site
Montreal, Quebec, H4J 1C5
Pfizer Investigational Site
Oshawa, Ontario, L1G 2B9
About this study
Official title: A Phase 2, Randomized, Open Label Study Of Figitumumab (CP-751,871) Plus Cisplatin (Or Carboplatin) And Etoposide, Versus Cisplatin (Or Carboplatin) And Etoposide Alone, As First Line Treatment In Patients With Extensive Stage Disease Small Cell Lung Cancer
This study will summarize the safety of patients receiving figitumumab combined with etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung Cancer.
Read the detailed description
The study prematurely discontinued on January 26, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
- Conditions
- Small Cell Lung Carcinoma
- Being tested
- figitumumab, Cisplatin (Or Carboplatin), Etoposide
- Keywords
- Small Cell Lung Cancer, Extensive stage disease, SCLC, IGF-1R inhibitor
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
figitumumabDrug
Figitumumab (20 mg/kg)
Cisplatin (Or Carboplatin)Drug
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
EtoposideDrug
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
Cisplatin (Or Carboplatin)Drug
Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5
EtoposideDrug
Etoposide (100 mg/m2 IV on Days 1, 2 and 3)
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Figitumumab (CP-751,871) Plus Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle Receives: Drug: figitumumab; Drug: Cisplatin (Or Carboplatin); Drug: Etoposide |
| Arm B | Active comparator | Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle Receives: Drug: Cisplatin (Or Carboplatin); Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS time (days) = [event (progression or death) date or censor date - date of randomization + 1].
Measured: Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
Secondary outcomes (13)
Number of Participants With Objective Response
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST.
Measured: Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
Overall Survival (OS)
Overall survival was the duration from enrollment to death due to any cause. For participants who are alive, overall survival was censored at the last contact. Survival time (days) = [death date (last known alive date) - date of randomization +1].
Measured: Every 3 months until death or 12 months from the date the last participant was randomized
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs are any untoward, undesired, or unplanned event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study treatment. The event does not need to be causally related to the study treatment. SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly or birth defect in the offspring of a study subject.
Measured: Baseline up to follow-up (90 days post dose)
Maximum Observed Plasma Concentration (Cmax) of Figitumumab
Measured: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
Minimum Observed Plasma Trough Concentration (Cmin) of Figitumumab
Measured: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Etoposide
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
Maximum Observed Plasma Concentration (Cmax) of Etoposide
Measured: Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab
Percentage of participants with positive total or neutralizing anti-drug antibody (ADA) for figitumumab
Measured: Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose
Cancer Dyspnea Scale (CDS) Score
The Cancer Dyspnea Scale consists of 12 questions that assess 3 domains of dyspnea (sense of effort, anxiety and discomfort) related to lung cancer. The questions are answered on 5-point Likert scale ranging from 1 to 5 (1 "Not at All" to 5 "Very Much").
Measured: Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
Numeric Rating Scale (NRS) Score
The Numeric Rating Scale (NRS) is a 1-item self-reported questionnaire designed to assess "worst pain" severity. Overall scores range from 0 to 10, with low scores representing a lower level of pain.
Measured: Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway
Measured: Baseline prior to dosing
Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers
Measured: Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)
Number of Total Circulating Tumor-Related Cells (CTCs) and Insulin-Like Growth Factor 1 Receptor (IGF-IR)-Expressing CTCs
Pre-treatment and post-treatment counts of total and IGF-IR-positive CTCs
Measured: Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startApr 2010
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: See termination reason in detailed description.
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 Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977561
- Sponsor's protocol ID
- A4021032
- Status last verified
- Jan 2013
- First submitted
- 10 Sep 2009
- Last updated
- 25 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open Label Study Of Figitumumab (CP-751,871) Plus Cisplatin (Or Carboplatin) And Etoposide, Versus Cisplatin (Or Carboplatin) And Etoposide Alone, As First Line Treatment In Patients With Extensive Stage Disease Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00977561
- Acronym / sponsor ID
- A4021032
- Conditions
- Small Cell Lung Carcinoma
- Keywords
- Small Cell Lung Cancer, Extensive stage disease, SCLC, IGF-1R inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Sep 2009 (estimated)
- Results
- Posted 25 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will summarize the safety of patients receiving figitumumab combined with etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung Cancer.
Detailed description
The study prematurely discontinued on January 26, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: figitumumab, Drug: Cisplatin (Or Carboplatin), Drug: EtoposideFigitumumab (CP-751,871) Plus Chemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle |
| Arm B | Active comparator | Drug: Cisplatin (Or Carboplatin), Drug: EtoposideChemotherapy [Cisplatin (Or Carboplatin) And Etoposide] All drugs to be administered on a 21 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically confirmed diagnosis of extensive stage disease Small Cell Lung Cancer (SCLC), with tumor biopsy sample required.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Total IGF-1 > or = 120 ng/ml
Key exclusion criteria (2 listed)
- Any prior systemic therapy for Small Cell Lung Cancer (SCLC)
- HbA1c > or = 5.7%
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 |
|---|---|---|
| figitumumabFigitumumab (20 mg/kg) | Drug | Arm A |
| Cisplatin (Or Carboplatin)Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5 | Drug | Arm A |
| EtoposideEtoposide (100 mg/m2 IV on Days 1, 2 and 3) | Drug | Arm A |
| Cisplatin (Or Carboplatin)Cisplatin (75 mg/m2 IV on Day 1) or Carboplatin AUC 5 | Drug | Arm B |
| EtoposideEtoposide (100 mg/m2 IV on Days 1, 2 and 3) | Drug | Arm B |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS time (days) = [event (progression or death) date or censor date - date of randomization + 1].
13 secondary outcomes
Number of Participants With Objective Response
Time frame: Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression
Overall Survival (OS)
Time frame: Every 3 months until death or 12 months from the date the last participant was randomized
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to follow-up (90 days post dose)
Maximum Observed Plasma Concentration (Cmax) of Figitumumab
Time frame: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
Minimum Observed Plasma Trough Concentration (Cmin) of Figitumumab
Time frame: Cycle 1, Day 2; Day 1 of Cycles 2, 4, 5, 6, 10 and 15; Day 28 and Day 90 post last figitumumab dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Etoposide
Time frame: Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
Maximum Observed Plasma Concentration (Cmax) of Etoposide
Time frame: Cycles 1 and 2, Day 1 and Day 2 (within 3 hours prior to Day 1 etoposide infusion; 1, 1.5, 2, 3, 6, and 24 hours post Day 1 etoposide infusion); Cycles 4 and 5, Day 2: 24 hours post Day 1 etoposide infusion
Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab
Time frame: Day 2 of Cycle 1 (or Day 1 of the initial cycle starting single agent figitumumab); Day 1 of Cycles 2 and 4; Day 28 and Day 90 post last figitumumab dose
Cancer Dyspnea Scale (CDS) Score
Time frame: Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
Numeric Rating Scale (NRS) Score
Time frame: Day 1 of every cycle (up to 17 cycles), at the end of treatment visit (28 days post last dose); then every 6 weeks until disease progression
Pre-treatment Levels of Tumor Biomarkers Involved in Insulin-Like Growth Factor 1 (IGF-I) Signaling Pathway
Time frame: Baseline prior to dosing
Levels of Serum Circulating Insulin-like Growth Factor (IGF) Pathway Related Markers
Time frame: Baseline (Cycle 1, Day 1 prior to dosing), Cycle 4 (Day 1), at the end of treatment visit (28 days post last figitumumab dose)
Number of Total Circulating Tumor-Related Cells (CTCs) and Insulin-Like Growth Factor 1 Receptor (IGF-IR)-Expressing CTCs
Time frame: Baseline (Cycle 1, Day 1), Cycle 4 (Day 1) and at the end of treatment visit (28 days post last figitumumab dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Small Cell Lung Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
RecruitingPhase 2
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity
Carcinoma, Neuroendocrine, Tumor, Neuroendocrine
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Pfizer CT.gov Call Center study director
Pfizer
51 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing figitumumab, Cisplatin (Or Carboplatin) and Etoposide in people with Small Cell Lung Carcinoma, run by Pfizer at 51 sites in 4 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 25 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Spain, Hungary, Canada. 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?
Yes. Results are posted in the registry (first posted 25 Feb 2013). 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?
Progression-Free Survival (PFS) (time frame: Baseline, every 2nd cycle (between Day 15-21, 1 cycle = 21 days) starting with Cycle 2 until disease progression, at the end of treatment visit (if more than 28 days have passed since last evaluation); and every 6 weeks until disease progression). 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 25 Feb 2013.