Non Small Cell Lung Cancer (NSCLC) Clinical Trial
Official title:
A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer
| NCT number | NCT01323062 |
| Other study ID # | LCCC 1030 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | May 2011 |
| Est. completion date | October 1, 2018 |
| Verified date | December 2018 |
| Source | UNC Lineberger Comprehensive Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a non-randomized, open-label Phase 1b trial to establish the safety and recommended phase 2 dose (RP2D) of bavituximab in combination with pemetrexed and carboplatin in subjects with previously untreated stage IV non-squamous non-small cell lung cancer (NSCLC).
| Status | Completed |
| Enrollment | 26 |
| Est. completion date | October 1, 2018 |
| Est. primary completion date | May 14, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Greater than or equal to 18 - Histologically or cytologically confirmed stage IV non-squamous NSCLC not previously treated with systemic chemotherapy - Evaluable disease by clinical or radiographic parameters - No history or concomitant malignancy - Adequate organ and marrow function - Female subjects with negative urine or serum pregnancy - ECOG must be 0 or 1 Exclusion Criteria: - Squamous cell, small cell, or mixed histology - Known history of bleeding diathesis or coagulopathy - Cavitary tumors or tumors invading or abutting large blood vessels - Any history of thromboembolic events - Ongoing therapy with oral or parenteral anticoagulants - Major surgery within 4 weeks of Day 1 of treatment - Uncontrolled intercurrent disease (diabetes, hypertension, thyroid disease) - any history of significant vascular disease - Congestive heart failure - History of any condition requiring anti-platelet therapy - Serious non healing wound - Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis - Unable or unwilling to discontinue use of prohibited medications - D-dimers >2 x ULN as measured on 2 separate occasions at least 1 day apart |
| Country | Name | City | State |
|---|---|---|---|
| United States | Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| UNC Lineberger Comprehensive Cancer Center | Peregrine Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Measure number of severe side effects seen during first cycle of therapy | To determine the maximum tolerated dose based on occurrence of dose-limititing toxicity (DLT) within the first 3 weeks of treatment to determine appropriate and safe dose of bavituximab in combination with carboplatin and pemetrexed | Three weeks | |
| Secondary | Progression free survival | to determine the overall response rate and estimate progression free survival associated with bavituximab in combination with carboplatin and pemetrexed | At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death |
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