drugset / Trial / NCT02116777
Talazoparib and Temozolomide in Treating Younger Patients With Refractory or Recurrent Malignancies
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |