Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies and HER2 Negative Breast Cancer

Part of paid clinical trials in New York, New York.

Sponsor: Deborah Doroshow
Study ID: NCT04997993
Phase: PHASE1
Status: Recruiting

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Conditions

PTEN-Altered Advanced Solid Tumors and HER2 Negative Breast Cancer

Eligibility Criteria

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

Interventions

Leflunomide — DRUG
Leflunomide, 20-50mg PO daily

Study Details

Leflunomide in patients with PTEN-Altered advanced solid tumors or HER2 negative breast cancer. Phase 1A objectives are to determine the safety, tolerability, and the MTD of leflunomide in patients with PTEN-Altered advanced solid malignancies and HER2 negative breast cancer. Phase 1B objective is to assess preliminary evidence of clinical activity of leflunomide in these patient populations.

Key Dates

Start date: Dec 13, 2023
Status verified: Jun 2025
Primary completion: May 31, 2027
Completion: Dec 31, 2027

Study Design

Enrollment: 24 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Leflunomide
Leflunomide, 20-50mg PO daily

Primary Outcome Measure

Number of participants with Dose-limiting toxicities [ Time Frame: 1 month ]

Central Contacts

Deborah Doroshow, MD, PhD
(212) 241-5615
[email protected]
Natalie Lucas, DNP
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Icahn School of Medicine at Mount Sinai	New York	New York	10029	Deborah Doroshow, MD, PhD (PRINCIPAL_INVESTIGATOR)

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Icahn School of Medicine at Mount Sinai· New York, NY