Dose Escalation and Double-blind Study of Veliparib in Combination With Carboplatin and Etoposide in Treatment-naive Extensive Stage Disease Small Cell Lung Cancer

Phase 1/2 Completed 221 enrolled AbbVie

RandomizedSequentialDouble-blindTreatment

Summary

The study seeks to assess the efficacy of veliparib (ABT-888) in combination with carboplatin and etoposide in participants with extensive disease small cell lung cancer (ED SCLC).

Timeline

Start: 2014-10-13
Primary completion: 2019-04-17
Completion: 2019-04-17

Outcome

Missed primary endpoint

registry Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib vs Phase 2: Placebo + Carboplatin/Etoposide -> Placebo; p = 0.059 NCT02289690 ↗

Publications

Results Atrafi F, Groen HJM, Byers LA, Garralda E, Lolkema MP, Sangha RS, Viteri S, Chae YK, Camidge DR, Gabrail NY, Hu B, Tian T, Nuthalapati S, Hoening E, He L, Komarnitsky P, Calles A. A Phase I Dose-Escalation Study of Veliparib Combined with Carboplatin and Etoposide in Patients with Extensive-Stage Small Cell Lung Cancer and Other Solid Tumors. Clin Cancer Res. 2019 Jan 15;25(2):496-505. doi: 10.1158/1078-0432.CCR-18-2014. Epub 2018 Oct 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etoposide	Small molecule	100 mg/m2	Intravenous
Subject	Veliparib	Small molecule	80 mg	Oral
Subject	Veliparib	Small molecule	240 mg	Oral
Subject	Veliparib	Small molecule	400 mg	Oral
Background	Carboplatin	Small molecule	5 unknown	Intravenous