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A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non Small Cell Lung Cancer (NSCLC)

Thank you

Trial Information

A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Measure number of severe side effects seen during first cycle of therapy

Outcome Description:

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

Outcome Time Frame:

Three weeks

Safety Issue:

Yes

Principal Investigator

Juneko Grilley Olson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

U of North Carolina at Chapel Hill

Authority:

United States: Food and Drug Administration

Study ID:

LCCC 1030

NCT ID:

NCT01323062

Start Date:

May 2011

Completion Date:

May 2018

Related Keywords:

  • Non Small Cell Lung Cancer (NSCLC)
  • chemotherapy naive
  • stage IV non squamous non small cell lung cancer
  • Phase 1b
  • Bavituximab
  • Chimeric 3G4
  • U of North Carolina at Chapel Hill
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15213