Bavituximab Plus Carbo and Pemetrexed in Chemo-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Subjects
This study is currently recruiting participants.
Verified March 2013 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborator:
Peregrine Pharmaceuticals
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01323062
First received: March 8, 2011
Last updated: March 4, 2013
Last verified: March 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Non Small Cell Lung Cancer (NSCLC) |
Drug: Bavituximab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1b Study of Bavituximab Plus Carboplatin and Pemetrexed in Chemotherapy-Naive Stage IV Non-Squamous Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by UNC Lineberger Comprehensive Cancer Center:
Primary Outcome Measures:
- Measure number of severe side effects seen during first cycle of therapy [ Time Frame: Three weeks ] [ Designated as safety issue: Yes ]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
Secondary Outcome Measures:
- Progression free survival [ Time Frame: At the time from the start of treatment until documented disease as defined bia RECIST 1.1 or death ] [ Designated as safety issue: Yes ]to determine the overall response rate and estimate progression free survival associated with bavituximab in combination with carboplatin and pemetrexed
| Estimated Enrollment: | 25 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | May 2018 |
| Estimated Primary Completion Date: | May 2016 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Bavituximab
Administered 3 mg/kg weekly
Other Name: chimeric 3G4
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323062
Contacts
| Contact: Donna Rowe, RN | (919) 966-7359 | donna_rowe@med.unc.edu |
Locations
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center, UNC | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Juneko Grilley Olson, MD 919-966-4432 juneko_grilley@med.unc.edu | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Principal Investigator: Liza Villaruz, MD | |
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Peregrine Pharmaceuticals
Investigators
| Principal Investigator: | Juneko Grilley Olson, MD | U of North Carolina at Chapel Hill |
More Information
Additional Information:
No publications provided
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01323062 History of Changes |
| Other Study ID Numbers: | LCCC 1030 |
| Study First Received: | March 8, 2011 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
|
chemotherapy naive stage IV non squamous non small cell lung cancer Phase 1b |
Bavituximab Chimeric 3G4 U of North Carolina at Chapel Hill |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Pemetrexed |
Antibodies, Monoclonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013