Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant RCC

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT06222593
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Carcinoma, Renal Cell

Eligibility Criteria

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

Interventions

  • Bicalutamide in combination with Sunitinib — DRUG
    Antineoplastics, Antiandrogen; CYP3A4 Inhibitor

Study Details

This is a Phase I/II open-label, efficacy and safety study of bicalutamide in combination with sunitinib in patients with advanced renal cell carcinoma (RCC) who have been treated with a receptor tyrosine kinase inhibitor (RTKI) and experienced disease progression.

Key Dates

Start date
Oct 1, 2024
Status verified
Mar 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2027

Study Design

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

Arms

  • Experimental: Bicalutamide in combination with Sunitinib
    Bicalutamide 50mg once a day (QD) in combination with sunitinib 37.5mg, 25mg or 50mg QD (2 weeks ON, 1 week OFF). Four or more 21 day-long cycles.

Primary Outcome Measure

To assess safety and tolerability of bicalutamide in combination with sunitinib in patients with RTKIs-resistant renal cell carcinoma. [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UB/ Great Lakes Cancer CareBuffaloNew York14203-

Find similar trials in Buffalo, NY

By research site
UB/ Great Lakes Cancer Care· Buffalo, NY

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