A Phase II Trial of Cabozantinib With Patients With Refractory GCTs

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Jennifer King
Study ID
NCT04876456
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Germ Cell Tumor
  • Non-seminomatous Germ Cell Tumor
  • Ovarian Germ Cell Tumor
  • Seminoma

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cabozantinib — DRUG
    Patients will be treated with Cabozantinib 60mg orally daily continuously until disease progression, unacceptable toxicity, or trial closure.

Study Details

The purpose of the CTO-IUSCCC-0752 study is to investigate the use of Cabozantinib for patients with incurable, refractory germ cell tumors. Patients will be treated until evidence of disease progression, non-compliance with study protocol, unacceptable major toxicity, at subject's own request for withdrawal, or if the study closes for any reason.

Key Dates

Start date
Jun 10, 2021
Status verified
Jan 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib
    Patients will be treated with Cabozantinib 60mg orally daily continuously until disease progression, unacceptable toxicity, or trial closure.

Primary Outcome Measure

Clinical benefit rate [ Time Frame: Start of the treatment until time of death or last follow up visit (up to 2 years) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University Melvin & Bren Simon Cancer CenterIndianapolisIndiana46202-

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Indiana University Melvin & Bren Simon Cancer Center· Indianapolis, IN

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