drugset / Trial / NCT02116777

Talazoparib and Temozolomide in Treating Younger Patients With Refractory or Recurrent Malignancies

NCT02116777

Phase 1/2 Completed 40 enrolled National Cancer Institute (NCI)
RandomizedSequentialOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and best dose of talazoparib and temozolomide and to see how well they work in treating younger patients with tumors that have not responded to previous treatment (refractory) or have come back (recurrent). Talazoparib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving talazoparib together with temozolomide may work better in treating younger patients with refractory or recurrent malignancies.

Timeline

Start
2014-05-16
Primary completion
2018-12-31
Completion
2018-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Talazoparib Small molecule 400 ug/m2 Oral
Subject Talazoparib Small molecule 600 ug/m2 Oral
Subject Temozolomide Small molecule 20 mg/m2 Oral
Subject Temozolomide Small molecule 30 mg/m2 Oral
Subject Temozolomide Small molecule 40 mg/m2 Oral
Subject Temozolomide Small molecule 55 mg/m2 Oral