ECOG E2511 Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib(ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer

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ECOG E2511 Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib(ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer

This is a 2-part study consisting of a lead-in phase I dose escalation trial to establish the safety and
determine the optimal dose of veliparib (ABT-888) that will be safely combined with standard doses
of cisplatin and etoposide (CE). This will be followed by a randomized double blind phase II clinical
study to compare CE plus placebo against CE plus veliparib in patients with previously untreated
SCLC.
2.1 Phase I Primary Endpoints
To determine the recommended phase II dose (RP2D) of veliparib to use in combination with
CE.
2.2 Phase II Primary Endpoints
To determine whether the addition of ABT-888 to cisplatin etoposide (CE) results in
improved progression free survival (PFS) over CE with placebo in the frontline therapy of
newly diagnosed extensive stage small cell lung cancer
2.3 Phase II Secondary Endpoints
2.3.1 To determine the overall survival (OS) associated with the combination of CE plus
ABT-888
2.3.2 To assess the overall response rate (ORR) as well as complete response rate
(CRR) associated with the combination of CE plus ABT-888
2.3.3 To determine the toxicity profile of the combination of ABT-888 and CE
chemotherapy in this patient population.
2.3.4 To conduct exploratory correlative analysis of the impact of select biomarkers.
2.3.5 To compare the overall toxicity profile and specifically the incidence and severity of
chemotherapy-induced peripheral neuropathy with the addition of ABT-888 to CE

Protocol Number051206
Principal InvestigatorJoseph Aisner
PhasePhase I/II
ScopeNational
Applicable Disease SitesLung
Participating InstitutionsRutgers Cancer Institute of New Jersey
Robert Wood Johnson University Hospital at Hamilton

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.