Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone in Patients Renal Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01806064|
Recruitment Status : Terminated (The study did not meet endpoint.)
First Posted : March 7, 2013
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Phase 1b: To evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose axitinib in patients with advanced renal cell carcinoma.
Phase 2: To estimate the PFS of patients with advanced or metastatic RCC by RECIST 1.1 criteria in patients treated with axitinib and TRC105 compared to those treated with axitinib alone, following failure of one prior VEGF TKI
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: TRC105 and Axitinib Drug: Axitinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||173 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase 2 Trial of Axitinib and TRC105 Versus Axitinib Alone (Including a lead-in Phase 1B Dose Escalation Portion) in Patients With Advanced or Metastatic Renal Cell Carcinoma|
|Actual Study Start Date :||March 8, 2013|
|Actual Primary Completion Date :||December 21, 2018|
|Actual Study Completion Date :||June 12, 2019|
Experimental: TRC105 and Axitinib
Patients randomized to receive TRC105 at 3 mg/kg on day 1, 7 mg/kg on day 4, and 10 mg/kg on day 8 and weekly thereafter in combination with axitinib 5 mg twice daily
Drug: TRC105 and Axitinib
Active Comparator: Axitinib
Patients randomized to receive axitinib 5 mg twice daily
Other Name: Inlyta
- Phase 1b: Number of Patients With DLT [ Time Frame: 12 Months ]Phase 1b: For dose limiting toxicity (DLT) evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.0 (CTCAE v4.0).
- Phase 2: Progression Free Survival (PFS) of Patients With RCC [ Time Frame: 15 Months ]Median progression free survival (PFS) of patients with advanced or metastatic RCC by RECIST 1.1. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Phase 1b & 2: Response Rate of Patients With RCC [ Time Frame: 15 Months ]Number of patients with partial response (PR) or complete response (CR) by RECIST 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
- Phase 2: Overall Response Rate of Patients With RCC by Choi [ Time Frame: 15 Months ]Overall response (OR) rate is the number of patients with partial response (PR) or complete response (CR) by Choi Criteria. Per Choi criteria for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), A decrease in size ≥ 10% or a decrease in tumor attenuation (Houndsfield units) ≥ 15% on CT and no new lesions; Overall Response (OR) = CR + PR.
- Phase 1b & 2: Trough Concentrations of TRC105 by Dose Level in Phase 1b [ Time Frame: 2.5 months (cycle 2 day 15) ]Trough Serum TRC105 concentrations at steady state (cycle 2 day 15) were measured using validated ELISA methods.
- Phase 1b & 2: Number of Patients With Development of Immunogenicity Antibodies. [ Time Frame: 12 months ]Anti-product antibody concentration were measured using validated ELISA methods.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806064
|Study Director:||Charles Theuer, MD PhDfirstname.lastname@example.org|