Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2018
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bavituximab
Administered 3 mg/kg weekly

Locations

Country Name City State
United States Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center Peregrine Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT01204099 - Study of PX-866 and Docetaxel in Solid Tumors Phase 1/Phase 2
Recruiting NCT04083599 - GEN1042 Safety Trial and Anti-tumor Activity in Subjects With Malignant Solid Tumors Phase 1/Phase 2
Completed NCT00148798 - Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX) Phase 3
Recruiting NCT06026410 - KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors Phase 1
Completed NCT02988817 - Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors Phase 1/Phase 2
Completed NCT01005797 - Study of Panobinostat in Combination With Sorafenib in Kidney, Soft Tissue or Lung Cancers Phase 1
Recruiting NCT00637910 - Tarceva Italian Lung Optimization tRial Phase 3
Active, not recruiting NCT03447678 - Pembrolizumab in First Line Treatment of Advanced NSCLC Patients With PD-L1 Low Tumors. Phase 2
Completed NCT02456246 - Piloting the Feasibility of FLT-PET/CT Non-Small Cell Lung Cancer Managed With SBRT N/A
Completed NCT02014324 - Single Scope Staging of Lung Cancer With Endosonography N/A
Terminated NCT01741155 - Study of SPI-1620 in Combination With Docetaxel Versus Docetaxel Alone for Patients With Non Small-cell Lung Cancer (NSCLC) Phase 2
Completed NCT01594398 - Study to Assess Food Effect on Pharmacokinetics of Entinostat in Subjects With Breast Cancer or Non-Small Cell Lung Cancer Phase 1
Active, not recruiting NCT04772989 - A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies Phase 1
Completed NCT01702844 - Single Arm on the Tolerability of Weekly Nab-paclitaxel Phase 2
Completed NCT00492206 - Study of Cetuximab With Radiation Followed by Consolidation Chemotherapy for NSCLC Phase 2
Completed NCT00820417 - Pharmocokinetic/Pharmacodynamic (PK/PD) Study of the Combination Cetuximab/Gefitinib Phase 1
Completed NCT02639026 - Trial Of Hypofractionated Radiotherapy In Combination With MEDI4736 And Tremelimumab For Patients With Metastatic Melanoma And Lung, Breast And Pancreatic Cancers Phase 1
Completed NCT01282437 - Prophylactic Cranial Irradiation (PCI) vs Observation in Stage III NSCLC Phase 3
Active, not recruiting NCT04721015 - Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors Phase 1
Not yet recruiting NCT05473156 - A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies Phase 1/Phase 2