Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05263050

Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors

Led by Fox Chase Cancer Center · Updated on 2025-12-03

111

Participants Needed

1

Research Sites

262 weeks

Total Duration

On this page

Sponsors

F

Fox Chase Cancer Center

Lead Sponsor

E

Exelixis

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a multi-site, three-cohort phase II trial of cabozantinib for IMDC all-risk frontline metastatic renal cell carcinoma (mRCC) patients OR any line mRCC patients who have not previously been treated with cabozantinib, and patients with pancreatic or extra-pancreatic neuroendocrine tumors.

CONDITIONS

Official Title

Trial of an Alternative Cabozantinib Dosing Schedule in Metastatic Renal Cell Carcinoma and Neuroendocrine Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed advanced renal cell carcinoma (clear cell or non-clear cell) for Cohorts A and B
  • For Cohort B, no prior systemic therapy for metastatic disease; prior neoadjuvant/adjuvant immunotherapy allowed if completed over 12 months ago
  • Treatment-nafve patients may join Cohort A if not candidates for nivolumab or if cabozantinib alone is preferred
  • Well differentiated neuroendocrine tumors (grades 1-3) with progression within 12 months for Cohort C
  • Prior or concurrent somatostatin analog therapy allowed if stable for 2 months in Cohort C
  • At least one measurable tumor lesion per RECIST 1.1
  • No uncontrolled hypertension; blood pressure controlled with treatment allowed
  • Age over 18 years
  • ECOG performance status 0 to 2
  • Normal organ and marrow function including leukocytes > 2000/mcL, neutrophils > 1500/mcL, platelets > 100,000/mcL, hemoglobin > 9 g/dL, bilirubin 64 1.5 x ULN (up to 3.0 mg/dL for Gilbert's syndrome), AST/ALT/ALP within limits, albumin > 2.8 g/dL, creatinine clearance > 30 mL/min/1.73 m2, and PT/INR or PTT < 1.3 x ULN
  • Ability to understand and sign informed consent
  • Sexually active fertile subjects and partners must agree to use medically accepted contraception during and for 4 months after treatment
Not Eligible

You will not qualify if you...

  • Systemic anti-cancer therapy or radiotherapy within 14 days or five half-lives prior to study entry
  • Radiation therapy for bone metastases within 2 weeks or other radiation within 4 weeks before first dose
  • Prior treatment with cabozantinib
  • For Cohort B, prior systemic therapy for advanced renal cell carcinoma not allowed
  • Active or suspected autoimmune disease for Cohort B, except certain controlled conditions
  • Use of systemic corticosteroids > 10 mg prednisone daily or other immunosuppressives within 14 days for Cohort B
  • Use of other investigational agents
  • Allergy to cabozantinib or similar compounds
  • Current or anticipated use of strong CYP3A4 inhibitors or inducers (topical use allowed)
  • Concomitant anticoagulation with certain agents except low-dose aspirin and some stable anticoagulants
  • Uncontrolled illnesses including active infection, severe heart failure, unstable angina, serious arrhythmias, or psychiatric/social conditions limiting compliance
  • Cardiovascular conditions including NYHA Class 3 or 4 heart failure, QTcF > 500 msec, uncontrolled hypertension >160/100 mm Hg
  • Recent stroke, myocardial infarction, or thromboembolic event within 6 months
  • Gastrointestinal conditions with high risk of perforation or fistula, recent abdominal fistula, GI perforation, bowel obstruction, or abscess within 6 months
  • Cavitating pulmonary lesions or endobronchial disease
  • Tumor lesions invading or encasing major blood vessels (except intrahepatic vasculature allowed)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Actively Recruiting

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Research Team

R

Ryan Romasko, MBA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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