Dose Escalation and Double-blind Study of Veliparib in Combination With Carboplatin and Etoposide in Treatment-naive Extensive Stage Disease Small Cell Lung Cancer
CompletedPhase 1, PHASE2Results postedLast updated 14 May 2020
What this trial tests
Phase 1, PHASE2 trial testing Veliparib in Small Cell Lung Cancer in 221 participants. Completed in 17 April 2019.
Adults 18 to 99, any sex, with Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)Primary· Cycle 1 Day -2 to pre-dose on Cycle 2 Day 1 (23 days)
A DLT was defined as any of the following drug-related toxicities, graded according to the Common Toxicity Criteria for Adverse Events (CTCAE), V.4.0:
1. Events associated with treatment delay \>14 days in initiating Cycle 2 therapy:
Grade 4 thrombocytopenia, neutropenia, or febrile neutropenia, or Grade 3 febrile neutropenia with fever for \> 7 days
2. Grade ≥ 3 non-hematologic toxicity with ≥ 2 grade increase from baseline and attributed to veliparib treatment, excluding nausea or vomiting for ≤ 48 hours or inadequately treated, electrolyte abnormalities resolving in ≤ 24 hours, hyperse
Group
Value
95% CI
Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide
0
Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide
0
Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide
0
Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide
0
Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide
1
Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide
0
Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide
1
Phase 1: Maximum Observed Plasma Concentration (Cmax) of VeliparibPrimary· Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose
Plasma concentrations of veliparib were determined using a validated online solid-phase extraction followed by high-performance liquid chromatography with tandem mass spectrometric detection (HPLC LC-MS/MS). The lower limit of quantitation (LLOQ) for veliparib was established at ≥ 1.05 ng/mL.
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of VeliparibPrimary· Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose
Plasma concentrations of veliparib were determined using a validated online solid-phase extraction followed by high-performance liquid chromatography with tandem mass spectrometric detection (HPLC LC-MS/MS). The lower limit of quantitation (LLOQ) for veliparib was established at ≥ 1.05 ng/mL.
Phase 1: Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose (AUC[0-8]) of VeliparibPrimary· Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose
The area under the plasma concentration-time curve from time 0 to 8 hours post-dose for veliparib was estimated using non-compartmental methods.
Phase 1: Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC[0-12]) of VeliparibPrimary· Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose
The area under the plasma concentration-time curve from time 0 to 12 hours post-dose for veliparib was estimated using non-compartmental methods. AUC(0-12) was calculated by assuming the concentration at 12 hours post-dose was the same as the pre-dose concentration.
Phase 1: Dose-normalized Maximum Observed Plasma Concentration of VeliparibPrimary· Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose
Plasma concentrations of veliparib were determined using a validated online solid-phase extraction followed by high-performance liquid chromatography with tandem mass spectrometric detection (HPLC LC-MS/MS). The lower limit of quantitation (LLOQ) for veliparib was established at ≥ 1.05 ng/mL.
Dose normalized Cmax is calculated as Cmax / veliparib dose in mg.
Phase 1: Dose-normalized Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose of VeliparibPrimary· Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose
The area under the plasma concentration-time curve from time 0 to 8 hours post-dose for veliparib was estimated using non-compartmental methods. Dose normalized AUC(0-8) is calculated as AUC(0-8) / veliparib dose in mg.
Phase 1: Dose-normalized Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose of VeliparibPrimary· Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose
The area under the plasma concentration-time curve from time 0 to 12 hours post-dose for veliparib was estimated using non-compartmental methods. AUC(0-12) was calculated by assuming the concentration at 12 hours post-dose was the same as the pre-dose concentration. Dose normalized AUC(0-12) is calculated as AUC(0-12) / veliparib dose in mg.
Phase 1: Maximum Observed Plasma Concentration (Cmax) of Etoposide With and Without VeliparibPrimary· Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.
Etoposide plasma concentrations were determined using liquid chromatography with tandem mass spectrometric detection with a lower limit of quantitation 160 ng/mL.
Group
Value
95% CI
Etoposide Cycle 1 Day 1 (With Veliparib)
16.9
± 18
Etoposide Cycle 2 Day 1 (No Veliparib)
16.4
± 21
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Etoposide With and Without VeliparibPrimary· Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.
Etoposide plasma concentrations were determined using liquid chromatography with tandem mass spectrometric detection with a lower limit of quantitation 160 ng/mL.
Group
Value
95% CI
Etoposide Cycle 1 Day 1 (With Veliparib)
0.9
0.8 – 3.0
Etoposide Cycle 2 Day 1 (No Veliparib)
0.9
0.9 – 3.7
Phase 1: Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC[0-t]) of Etoposide With and Without VeliparibPrimary· Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.
The area under the plasma concentration-time curve from 0 to the last measurable concentration (24 hours) of etoposide was estimated using using non-compartmental methods.
Group
Value
95% CI
Etoposide Cycle 1 Day 1 (With Veliparib)
102
± 23
Etoposide Cycle 2 Day 1 (No Veliparib)
94.7
± 18
Phase 1: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-∞]) of Etoposide With and Without VeliparibPrimary· Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.
The area under the plasma concentration-time curve from 0 to infinity for etoposide was estimated using using non-compartmental methods.
Group
Value
95% CI
Etoposide Cycle 1 Day 1 (With Veliparib)
112
± 56
Etoposide Cycle 2 Day 1 (No Veliparib)
99.5
± 18
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide
Serious: 3/4 (75%)
Deaths: 0/4
Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide
Serious: 1/3 (33%)
Deaths: 0/3
Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide
Serious: 3/4 (75%)
Deaths: 1/4
Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide
Serious: 2/3 (67%)
Deaths: 1/3
Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide
Serious: 3/8 (38%)
Deaths: 0/8
Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide
Serious: 6/14 (43%)
Deaths: 0/14
Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03581292 — Veliparib, Radiation Therapy, and Temozolomide in Treating Patients With Newly Diagnosed Malignant Glioma Without H3 K27
· Phase 2
· active not recruiting
NCT03289910 — Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and
· Phase 2
· active not recruiting
NCT03032614 — Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
· Phase 2
· withdrawn
NCT02631733 — Liposomal Irinotecan and Veliparib in Treating Patients With Solid Tumors
· Phase 1
· completed
NCT03061188 — Phase I/Ib Study of Nivolumab & Veliparib in Patients With Advanced Solid Tumors & Lymphoma
· Phase 1
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 14 May 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02289690.