Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Tracking InformationStart Date ICMJE | June 2008 |
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Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
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Current Primary Outcome Measures ICMJE (submitted: July 14, 2008) | Progression Free Survival (PFS) [ Time Frame: Disease Progression ] [ Designated as safety issue: No ] |
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Original Primary Outcome Measures ICMJE | Same as current |
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Change History | Complete list of historical versions of study NCT00716534 on ClinicalTrials.gov Archive Site |
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Current Secondary Outcome Measures ICMJE (submitted: June 10, 2009) | - Overall survival, time to tumor progression, objective response rate, best response rate, best percent change in tumor size and duration of response [ Time Frame: Disease Progression ] [ Designated as safety issue: No ]
- Survival Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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Original Secondary Outcome Measures ICMJE (submitted: July 14, 2008) | - Overall survival, time to tumor progression, objective response rate, best response rate, maximum percent reduction in tumor size and duration of response. [ Time Frame: Disease Progression ] [ Designated as safety issue: No ]
- Survival Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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Descriptive InformationBrief Title ICMJE | Study of Carboplatin/Paclitaxel in Combination With ABT-869 in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) |
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Official Title ICMJE | A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of Carboplatin/Paclitaxel in Combination With ABT-869 Versus Carboplatin/Paclitaxel Alone in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) as First-Line Treatment |
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Brief Summary | This study is designed to determine the clinical efficacy and toxicity of ABT-869 in combination with carboplatin and paclitaxel in the treatment of subjects with advanced or metastatic NSCLC. |
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Detailed Description | |
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Study Phase | Phase II |
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Study Type ICMJE | Interventional |
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Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment |
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Condition ICMJE | Advanced or Metastatic Non-Small Cell Lung Cancer |
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Intervention ICMJE | - Drug: ABT-869
See arm for details Other Name: ABT-869 - Drug: Placebo
see arm for details
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Study Arms / Comparison Groups | - A: Experimental
12.5 mg ABT-869 Intervention: Drug: ABT-869 - B: Experimental
7.5 mg ABT-869 Intervention: Drug: ABT-869 - C: Placebo Comparator
Placebo (7.5 mg or 12.5 mg) Intervention: Drug: Placebo
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Recruitment InformationEstimated Enrollment ICMJE | 120 |
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Completion Date | |
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Estimated Primary Completion Date | March 2011 (final data collection date for primary outcome measure) |
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Eligibility Criteria ICMJE | Inclusion Criteria: - Subject must be at least 18 years of age.
- Subject must have cytologically or histologically confirmed non-squamous NSCLC
- Subject must have recurrent or advanced (Stage IIIb with pleural or pericardial effusion) or metastatic (Stage IV) disease that is not amenable to surgical resection or radiation with curative intent.
- Subject has measurable disease, defined as at least 1 unidimensional measurable lesion on a computed tomography (CT) scan as defined by RECIST (for subjects in the randomized portion only).
- Subject has an ECOG Performance Score of 0-1.
- Willing to take adequate measures to prevent pregnancy.
Exclusion Criteria: - The subject has NSCLC with a predominant squamous cell histology
- Subject has hypersensitivity to paclitaxel.
- Subject has received any anti-cancer therapy for treatment of NSCLC.
- Subject has received radiation therapy within 21 days of Study Day 1.
- Subject has had major surgery within 21 days.
- Subject has untreated brain or meningeal metastases.
- Subject is receiving therapeutic anticoagulation therapy.
- Subject has a central thoracic tumor lesion as defined by location within the hilar structures.
- Subject has proteinuria CTC Grade > 1 at baseline.
- Subject has a history of, or currently exhibits clinically significant cancer related events of bleeding.
- The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) > 90 mm Hg or systolic BP > 140 mm Hg.
- The subject has a history of myocardial infarction, stroke or Transient Ischemic Attack (TIA) within 6 months of Study Day 1.
- The subject has a documented left ventricular (LV) ejection fraction < 50%.
- The subject has known autoimmune disease with renal involvement (i.e., lupus).
- The subject is receiving combination anti-retroviral therapy for HIV.
- The subject has clinically significant uncontrolled condition(s).
- The subject has a history of another active cancer within the past 5 years.
- The subject has active ulcerative colitis, Crohn's disease, celiac disease or any other conditions that interfere with absorption.
- The subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
- The subject is pregnant or breast feeding.
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Gender | Both |
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Ages | 18 Years and older |
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Accepts Healthy Volunteers | No |
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Contacts ICMJE | |
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Location Countries ICMJE | United States, Australia, Czech Republic, Russian Federation, Singapore |
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Administrative InformationNCT ID ICMJE | NCT00716534 |
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Responsible Party | Justin Ricker MD, PhD/Global Medical Director, Abbott |
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Study ID Numbers ICMJE | M10-301 |
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Study Sponsor ICMJE | Abbott |
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Collaborators ICMJE | Genentech |
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Investigators ICMJE | |
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Information Provided By | Abbott |
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