CRLX101 in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC)
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|ClinicalTrials.gov Identifier: NCT02187302|
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : April 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Renal Cell Carcinoma||Drug: CRLX101 Drug: Bevacizumab Drug: Standard of Care (Investigator Choice)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Phase 2 Study to Assess the Safety and Efficacy of CRLX101 in Combination With Bevacizumab in Patients With Metastatic Renal Cell Carcinoma (RCC) Versus Standard of Care (SOC) (Investigator's Choice)|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||January 2017|
Experimental: CRLX101 + bevacizumab
CRLX101 in combination with bevacizumab:
Other Name: Avastin
Active Comparator: Standard of Care
Standard of care treatment include one of the following agents to which the patient can have no prior exposure: sorafenib; everolimus; pazopanib; axitinib; bevacizumab; sunitinib, or other approved drug considered by the Medical Monitor to represent an acceptable standard of care therapy
Drug: Standard of Care (Investigator Choice)
- Progression Free Survival (PFS) [ Time Frame: at least 6 months ]To assess progression free survival (PFS) in patients with clear cell metastatic renal cell carcinoma (RCC) treated with CRLX101 in combination with bevacizumab (CRLX101+bevacizumab) vs. standard of care (SOC) per investigator's choice, as assessed by blinded independent radiological review (IRR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Overall Safety and tolerability (AEs, SAEs, Clinical Laboratory Parameters, Vital Signs, Concomitant Medications) [ Time Frame: at least 30 days post last dose of study drug ]
AEs will be coded using MedDRA and graded according to CTCAE (v 4.03). The number and percentage of patients with any treatment-emergent AE (TEAE) will be summarized for each treatment group. The number of patients with TEAEs assessed by the Investigator as at least possibly related to treatment will be tabulated. The number of patients with any CTCAE grade ≥ 3 treatment-emergent AE will be tabulated. Serious AEs (SAEs) will also be tabulated.
For Clinical Laboratory Parameters - Shift tables that present changes from baseline to worst on-study values relative to CTCAE grading will be produced.
For Vital Signs - By-patient data listings of vital sign measurements will be presented.
For Concomitant Medications - The use of concomitant medications will be included in by-patient data listings. A summary table of concomitant medications by WHO drug class will also be provided.
- Overall survival [ Time Frame: on average 12 months after discontinuation of study treatment ]To compare time to death between treatment groups of CRLX101 in combination with bevacizumab compared to SOC.
- Objective response rate [ Time Frame: at least 6 months ]Evaluate response rates comparing the investigational treatment of CRLX101 in combination with bevacizumab compared to SOC as assessed by blinded IRR as well as by the Investigator
- Duration of Response [ Time Frame: at least 6 months ]Evaluate time to response comparing the investigational treatment of CRLX101 in combination with bevacizumab compared to SOC as assessed by blinded IRR as well as by the Investigator
- PFS [ Time Frame: at least 6 months ]To assess PFS in patients with clear cell metastatic RCC treated with CRLX101+bevacizumab vs. SOC per investigator's choice, as assessed at the site level by the Investigator according to RECIST version 1.1
- PFS [ Time Frame: at least 6 months ]To assess PFS (as assessed at the site level by the Investigator and separately by blinded IRR) in clear cell RCC patients treated with CRLX101+bevacizumab compared to bevacizumab treatment alone
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): NCT02187302
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|Study Chair:||NewLink Genetics||NewLink Genetics Inc|