Pilot Study of Veliparib (ABT-888) and Lapatinib (Tykerb) in Patients With Metastatic, Triple Negative Breast Cancer

Conditions

• Metastatic Triple Negative Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

19 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Combination of Veliparib + Lapatinib — DRUG
  Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs.

Study Details

This study will evaluate the effectiveness and safety of the combination of two drugs, Veliparib and Lapatinib, given to participants with metastatic triple negative breast cancer that have undergone previous treatment. Veliparib is an investigational drug and has not been approved by the FDA while Lapatinib has been approved by the FDA for another type of breast cancer. All eligible participants will receive the study medications and not a placebo.

Key Dates

Start date

Sep 4, 2014

Status verified

Dec 2025

Primary completion

Jul 22, 2021

Completion

Jul 22, 2021

Study Design

Enrollment

20 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Combination of Veliparib + Lapatinib
  Lapatinib will be administered as a tablet at a dosage of 1250 mg/day continuously for 28 days starting on Day 1 of each cycle. Veliparib will be administered as a capsule at a dosage of 200 mg every 12 hours for 28 days starting on Day 2 of each cycle. A cycle of therapy is defined as 28 days. Treatment is administered on an outpatient basis. Patient response will be evaluated every 8 weeks according to the current Response Evaluation Criteria in Solid Tumors (RECIST) guidelines and performance of relevant scans and/or x-rays.

Primary Outcome Measure

Number of Subjects Experiencing Study-related Toxicities When Taking Veliparib in Combination With Lapatinib [ Time Frame: baseline to 4 years ]

Locations (1)

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