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Type(s) of Cancer
Lung
Study Phase
Phase 1Phase 2
Study Completion Date
2016-12-08
NCT01642251Uploaded 04-18-2023
Access via NCI by Request
PDS UID: nci-data-517
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
Provider Information
Provider Data DescriptionThere are two different submissions (each with one dataset) for PMID 30523756 from ECOG-ACRIN trial E2511. This dataset, NCT01642251-D1, contains baseline, treatment, and efficacy data. Dataset NCT01642251-D2 contains toxicity data.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase I/II trial studies the side effects and best dose of veliparib when given together with or without cisplatin and etoposide and to see how well they work in treating patients with extensive stage small cell lung cancer or large cell neuroendocrine non-small cell lung cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cisplatin and etoposide with or without veliparib may work better in treating patients with extensive stage small cell lung cancer or metastatic large cell neuroendocrine non-small cell lung cancer.
ConditionsExtensive Stage Small Cell Lung Carcinoma
Large Cell Lung Carcinoma
Neuroendocrine Carcinoma
Small Cell Carcinoma
Stage IV Non-Small Cell Lung Cancer AJCC v7
Intervention TypeDrug: Cisplatin
Drug: Etoposide
Drug: Veliparib
Drug: Placebo
Drug(s)Drug: Cisplatin
Drug: Etoposide
Drug: Veliparib
Drug: Placebo
Total Enrolled156
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm A (veliparib) - Experimental
Arm B (placebo) - Active Comparator
Secondary IDE2511
PubMed (PMID)30523756
32860331
Collaborator(s)N/A
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01642251-D1
Data DictionaryNCT01642251-D1-Data-Dictionary_3.pdf
DATANCT01642251-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01642251-D2
Data DictionaryNCT01642251-D2-Data-Dictionary_3.pdf
DATANCT01642251-D2-Dataset_2.csv
OTHERREADME.pdf
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