Status:
COMPLETED
CRLX101(NLG207) in Combination With Bevacizumab for Metastatic Renal Cell Carcinoma (mRCC) Versus Standard of Care (SOC)
Lead Sponsor:
NewLink Genetics Corporation
Conditions:
Metastatic Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT02187302
Start Date
July 1 2014
End Date
January 1 2017
Last Update
May 28 2020
Active Locations (43)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California San Diego
La Jolla, California, United States, 92093
2
David Geffen School of Medicine UCLA
Los Angeles, California, United States, 90024
3
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
4
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218