Trials / Completed
CompletedNCT01323062
Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects
A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- UNC Lineberger Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
Subjects with measurable disease will be assessed for response after every 2 cycles of therapy using RECIST 1.1 criteria. In addition, progression free survival (PFS), overall survival (OS) and exploratory biomarkers, imaging, and thrombotic risk parameters will be evaluated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bavituximab | Administered 3 mg/kg weekly |
Timeline
- Start date
- 2011-05-01
- Primary completion
- 2014-05-14
- Completion
- 2018-10-01
- First posted
- 2011-03-25
- Last updated
- 2018-12-04
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01323062. Inclusion in this directory is not an endorsement.