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A Randomized, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Squamous Non-Small Cell Lung Cancer

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Trial Information

A Randomized, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients With Previously Untreated Locally Advanced or Metastatic Non-Squamous Non Small-Cell Lung Cancer


Key

Inclusion Criteria:



- Adults over 18 years of age with a life expectancy of at least 3 months.

- Histologically or cytologically confirmed stage IIIB or stage IV non-squamous NSCLC
that has not been previously treated with systemic chemotherapy.

- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST, Version
1.1).

- Adequate hematologic, renal and hepatic function.

- PT / INR ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN and D-dimer ≤ 3 × ULN.

Key Exclusion Criteria:

- Squamous cell, small cell, or mixed histology.

- Known history of bleeding diathesis or coagulopathy.

- Cavitary tumors or tumors abutting large blood vessels.

- Bleeding: Clinically significant bleeding, such as gross hematuria, GI bleeding and
hemoptysis, within 12 months of Screening.

- Venous thromboembolic events (e.g., deep vein thrombosis or pulmonary
thromboembolism) within 6 months of Screening.

- Ongoing therapy with oral or parenteral anticoagulants.

- Concurrent estrogens, anti-estrogens or progesterone compounds.

- Grade 2 or higher peripheral neuropathy.

- Radiotherapy within 2 weeks preceding Study Day 1.

- Symptomatic or clinically active brain metastases.

- Major surgery within 4 weeks of Study Day 1.

- Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease).

- Symptomatic coronary artery disease, cerebrovascular accident,transient ischemic
attack, myocardial infarction, or unstable angina pectoris within 6 months of
Screening.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Time Frame:

Until disease progression

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

PPHM 1001

NCT ID:

NCT01160601

Start Date:

June 2010

Completion Date:

July 2013

Related Keywords:

  • Non-squamous Non-small Cell Lung Cancer
  • NSCLC
  • lung cancer
  • non small cell lung cancer
  • bavituximab
  • monoclonal antibody
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Community HospitalMunster, Indiana  46321
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
The Center for Cancer and Hematologic DiseaseCherry Hill, New Jersey  08003
Gabrail Cancer CenterCanton, Ohio  44718
San Juan Oncology AssociatesFarmington, New Mexico  87401
Southeast Nebraska Cancer CenterLincoln, Nebraska  68510
Baptist Cancer InstituteJacksonville, Florida  32207
Cedar Valley Medical Specialists, PCWaterloo, Iowa  50702
The Christ Hospital Cancer Center ResearchCincinnati, Ohio  45219
Signal Point Clinical Research Center, LLCMiddletown, Ohio  45042
Gettysburg Cancer CenterGettysburg, Pennsylvania  17325
Ironwood Cancer and Research CenterChandler, Arizona  85224
American Institute of ResearchWhittier, California  90603
Baptist Clinical ResearchJonesboro, Arkansas  72401
Hematology-Oncology of Knoxville/Mercy Medical CenterKnoxville, Tennessee  37909
Delta Hematology Oncology Associates, PCPortsmouth, Virginia  23704