A Phase I Study of ABT-888 in Combination With Temozolomide in Cancer Patients

Phase 1 Completed 41 enrolled AbbVie

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Temozolomide (chemotherapy) in treating patients with solid tumors, including metastatic melanoma (MM), BRCA deficient breast, ovarian, primary peritoneal, or fallopian tube cancer, and hepatocellular carcinoma (HCC).

Timeline

Start: 2007-08
Primary completion: 2010-06
Completion: —

Publications

Results Nuthalapati S, Munasinghe W, Giranda V, Xiong H. Clinical Pharmacokinetics and Mass Balance of Veliparib in Combination with Temozolomide in Subjects with Nonhematologic Malignancies. Clin Pharmacokinet. 2018 Jan;57(1):51-58. doi: 10.1007/s40262-017-0547-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Temozolomide	Small molecule	150 mg/m2	Oral
Subject	Temozolomide	Small molecule	200 mg/m2	Oral
Subject	Veliparib	Small molecule	10 mg	Oral
Subject	Veliparib	Small molecule	80 mg	Oral

A Phase I Study of ABT-888 in Combination With Temozolomide in Cancer Patients

Summary

Timeline

Publications

Drugs

Indications