A Study of TRC105 in Combination With Paclitaxel/Carboplatin and Bevacizumab in Non-Squamous Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02429843|
Recruitment Status : Recruiting
First Posted : April 29, 2015
Last Update Posted : January 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: TRC105||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1B Dose-Escalation Study of TRC105 in Combination With Paclitaxel/Carboplatin and Bevacizumab in Patients With Stage 4 Non-Squamous Cell Lung Cancer|
|Actual Study Start Date :||September 27, 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2020|
Experimental: Standard treatment + TRC105
In addition to standard treatment of paclitaxel, carboplatin, and bevacizumab, dosing of TRC105 will begin at 8 mg/kg. However a lower dose level has also been included (6 mg/kg) and will be enrolled if 8 mg/kg is found to exceed the maximum tolerated dose. Following the appropriate pre-medication regimen, the first weekly TRC105 dose (cycle 1 day 8) will be split into two doses whereby 3 mg/kg is administered on cycle 1 day 8 and the balance (e.g., 5 mg/kg for Dose Level 1) is administered on cycle 1 day 11. Beginning with cycle 1 day 15 and thereafter, the full TRC105 dose will be administered intravenously each week during the 21-day cycle. Intra-patient dose reductions are allowed beginning in cycle 2.
Each patient will be dosed with 6, 8, or 10 mg/kg of TRC105 up to a maximum dose of 850 mg for women and 1,000 mg for men based upon overall body weight.
- Number of patients with a change in medical management [ Time Frame: Baseline up to 28 days after the last cycle ]Adverse events will be graded using the NCI Common Terminology for Criteria for Adverse Events(CTCAE). Incidence, timing, and relatedness of adverse events will be considered as factors in the change of a patient's medical management.
- Measurement of tumor response [ Time Frame: Baseline to 3 years ]Radiological tumor assessments from CT or MRI scans will be used to determine an objective response rate.
- Progression-free survival [ Time Frame: Baseline to 3 years ]Time to progressive disease
- Number of patients with progression-free survival at 6 months [ Time Frame: 6 months after the last cycle of treatment completed ]The percentage of patients with progression-free survival in the study
- Overall survival [ Time Frame: Baseline to 3 years ]Length of patient survival after starting study treatment
- Measurement of TRC105 concentrations [ Time Frame: Collected approximately every 63 days (3 cycles) ]Serum TRC105 concentrations will be measured using validated enzyme-linked immunoassay testing that will assist in analyzing the pharmacokinetics of the drug.
- Measurement of TRC105 anti-product antibodies [ Time Frame: Collected approximately every 63 days (3 cycles) ]Anti-product antibody concentrations will be measured using validated enzyme-linked immunoassay testing that will assist in analyzing immunogenicity.
- Identify angiogenic protein biomarkers [ Time Frame: Collected approximately every 63 days (3 cycles) ]A central reference lab will conduct biomarker testing that will assist in the analysis of the pharmacodynamics effects on circulating angiogenic biomarkers.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02429843
|Contact: Francisco Robert, MDemail@example.com|
|Contact: Mary S Jerome, RN, BSN, OCNfirstname.lastname@example.org|
|United States, Alabama|
|UAB Comprehensive Cancer Center||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Mary S Jerome, RN, BSN, OCN 205-934-5092 email@example.com|
|Principal Investigator: Francisco Robert, M.D.|
|Principal Investigator:||Francisco Robert, MD||University of Alabama at Birmingham|