A Phase 1B Dose-escalation Study of TRC105 in Combination With Axitinib in Patients With Advanced Renal Cell Carcinoma

Status: Recruiting
Phase: Phase 1
Diagnosis: Kidney Cancer
NCT ID: NCT01806064 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-170

 

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.

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Toni Choueiri, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
David McDermott, MD, Beth Israel Deaconess Medical Center
Dror Michaelson, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Meghara Walsh, 617-632-5264, mwalsh10@partners.org
Dana-Farber Cancer Institute: Amanda Fredericks, 617-632-5514, acfredericks@partners.org
Dana-Farber Cancer Institute: Judith Prisby, 617-632-5068, jprisby@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: 1. Histologically confirmed advanced renal cell carcinoma that has progressed following treatment with at least one multi-targeted tyrosine kinase inhibitor that targets the VEGF receptor (e.g., sunitinib, pazopanib, sorafenib, tivozanib). Prior immunotherapy, bevacizumab or mTOR inhibitor treatment is allowed. Prior axitinib is allowed if the drug was not discontinued for toxicity. 2. No history of other carcinoma within the last five years, and/or where the risk of recurrence is known to be under 5% 3. Measurable disease by RECIST criteria 4. Age of 18 years or older 5. ECOG performance status ≤ 1 6. Resolution of all acute adverse events resulting from prior cancer therapies to NCI CTCAE grade ≤ 1 or baseline (except alopecia) 7. Willingness and ability to consent for self to participate in study Exclusion Criteria: 1. Prior treatment with TRC105 2. Current treatment on another therapeutic clinical trial 3. Receipt of a small molecule anticancer agent, including an investigational anticancer small molecule, within 14 days of starting study treatment 4. Receipt of a large molecule anticancer agent (e.g., antibody), including an investigational anticancer antibody, within 28 days of starting study treatment 5. Prior surgery (including open biopsy) within 28 days of starting the study treatment or the anticipated need for a major surgical procedure within the next six months 6. Prior radiation therapy within 28 days of starting the study treatment, except radiation therapy for bone metastases is permitted up to 14 days of starting treatment 7. Minor surgical procedures such as fine needle aspiration, Mediport placement or core biopsy within 7 days of study treatment 8. Uncontrolled chronic hypertension defined as systolic > 150 or diastolic > 90 despite optimal therapy (initiation or adjustment of BP medication prior to study entry is allowed provided that the average of 3 BP readings at a visit prior to enrollment is < 140/90 mm Hg) 9. Symptomatic ascites or pericardial or pleural effusion 10. History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. Patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive, patients are asymptomatic, and no steroids have been administered for at least 30 days. 11. Angina, MI, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, pulmonary embolism, Venous thrombosis, including pulmonary embolism and deep venous thrombosis (unless adequately anticoagulated without warfarin for more than two weeks), PTCA or CABG within the past 6 months 12. Active bleeding or pathologic condition that carries a high risk of bleeding (e.g. hereditary hemorrhagic telangiectasia). Patients who have been uneventfully anti-coagulated with low molecular weight heparin are eligible. 13. Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to first day of study therapy 14. Cardiac dysrhythmias of NCI CTCAE grade ≥ 2 within the last 28 days 15. Known active viral or nonviral hepatitis or cirrhosis 16. History of hemorrhage or hemoptysis (> ½ teaspoon bright red blood) within 6 months of starting study treatment 17. Pregnancy or breastfeeding. Female patients must be surgically sterile (i.e.: hysterectomy) or be postmenopausal, or must agree to use effective contraception during the study and for 3 months following last dose of TRC105.
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