Overview

This trial has been completed.

Condition metastatic renal cell carcinoma
Treatments crlx101, bevacizumab, standard of care (investigator choice)
Phase phase 2
Targets VEGF, RAF, PDGF, mTOR, FLT-3, KIT, FKBP-12
Sponsor NewLink Genetics Corporation
Start date July 2014
End date July 2016
Trial size 115 participants
Trial identifier NCT02187302, CRLX101-208

Summary

This study to evaluate treatment in patients with metastatic renal cell carcinoma (RCC) which has progressed through 2 to 3 prior lines of therapy, with the investigational drug CRLX101 in combination with bevacizumab compared to treatment with a standard of care therapy. The study will compare which treatment resulted in longer time before progression of the RCC. Patients will be treated and followed for progression of their disease on average for up to 6 months.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
CRLX101 in combination with bevacizumab: CRLX101 15 mg/m^2 IV on days 1 and 15 of a 28-day cycle; bevacizumab 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
crlx101
bevacizumab Avastin
(Active Comparator)
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
standard of care (investigator choice) sorafenib (Nexavar), sunitinib (Sutent), axitinib (Inlyta), pazopanib (Votrient), bevacizumab (Avastin),

Primary Outcomes

Measure
Progression Free Survival (PFS)
time frame: at least 6 months

Secondary Outcomes

Measure
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
Overall survival
time frame: on average 12 months after discontinuation of study treatment
Objective response rate
time frame: at least 6 months
Duration of Response
time frame: at least 6 months
PFS
time frame: at least 6 months
PFS
time frame: at least 6 months

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: - Must have histologically confirmed renal cell carcinoma of any pathologic subtype. - Must have unresectable metastatic disease, and have tumor(s) present that is (are) evaluable by the RECIST, v1.1; may have spinal-associated metastases but must have concluded dexamethasone therapy and be evaluated by the Investigator to have stable CNS disease. - Must have received 2 or 3 prior lines of conventional molecularly targeted therapy - Must have full recovery from any toxicities from prior therapy CTCAE Grade 1 or less with the exception of Grade 2 alopecia) prior to randomization. - ECOG performance status 0 or 1. - Age 18 years and older. - Life expectancy of at least 3 months. - Must have normal organ and marrow function reported within 14 days prior to randomization - Ability to understand and willingness to sign a written informed consent document. - Able to comply with study visit schedule and assessments. Exclusion Criteria: - Any conventional molecularly targeted therapy within 2 weeks or, chemotherapy or radiotherapy within 2 weeks (local) or 4 weeks (systemic) prior to entering the study. - Failure to recover to grade 1 or less all prior adverse events. - Any major surgery within 4 weeks of study randomization. - Any prior treatment with topoisomerase I therapy. - Prior treatment with any drugs or therapies that will be administered during the course of this trial including CRLX101, any topoisomerase 1 inhibitor, bevacizumab or the conventional molecularly targeted agent intended for use as standard of care treatment. - Patients receiving any other current investigational therapeutic agent. - Other active malignancies - Patients with brain metastasis treated or untreated, or other CNS disease - Any clinically significant cardiac disease defined as NYHA class III or IV. - Uncontrolled hypertension - Uncontrolled concurrent illness - History of non-healing wounds or ulcers. - Pregnancy, or inadequate contraception for men or women of childbearing age, or lactating / breast-feeding - Patients with known HIV or with solid organ transplant

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in April 2017.
Information provided to ClinicalTrials.gov by NewLink Genetics Corporation.