RecruitingPhase 1NCT04997993

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

A Phase IA/IB Trial of Leflunomide in Patients With PTEN-Altered Advanced Solid Malignancies and HER2 Negative Breast Cancer


Sponsor

Deborah Doroshow

Enrollment

24 participants

Start Date

Dec 13, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests leflunomide (a drug currently used for arthritis) as a new anti-cancer treatment in patients with advanced solid tumors that have lost the PTEN tumor suppressor gene, or in patients with HER2-negative advanced breast cancer who have exhausted other treatment options. **You may be eligible if...** - You are 18 or older with advanced or metastatic cancer - Your tumor has confirmed loss of PTEN protein expression or a PTEN gene mutation, OR you have advanced HER2-negative breast cancer - Your cancer has progressed on standard therapies - You are in good health (ECOG 0–2) with adequate blood, liver, and kidney function - You are willing to use contraception (or commit to a prolonged elimination protocol after stopping) **You may NOT be eligible if...** - You have a primary brain tumor - You received chemotherapy or radiation within 4 weeks before starting the study - You have a history of hepatitis B or C (due to leflunomide's effects on the liver) - You are allergic to leflunomide or teriflunomide - You have an uncontrolled infection, serious heart condition, or major psychiatric illness - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLeflunomide

Leflunomide, 20-50mg PO daily


Locations(1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

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NCT04997993