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

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ClinicalTrials.gov Identifier: NCT02289690
Recruitment Status : Active, not recruiting
First Posted : November 13, 2014
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

November 10, 2014
November 13, 2014
October 11, 2018
October 13, 2014
March 27, 2019   (Final data collection date for primary outcome measure)
  • Recommended Phase 2 dose of veliparib (ABT-888) in combination with carboplatin and etoposide [ Time Frame: Approximately 2 years ]
  • Maximum tolerated dose (MTD) of veliparib (ABT-888) in combination with carboplatin and etoposide [ Time Frame: Approximately 2 years ]
  • Maximum tolerated dose (MTD) of veliparib (ABT-888) in combination with carboplatin and etoposide [ Time Frame: Approximately 2 years ]
  • Recommended Phase 2 dose of veliparib (ABT-888) in combination with carboplatin and etoposide [ Time Frame: Approximately 2 years ]
Complete list of historical versions of study NCT02289690 on ClinicalTrials.gov Archive Site
Frequency of adverse events during maintenance veliparib monotherapy at 400 mg twice daily (BID) [ Time Frame: Approximately 2 years ]
Same as current
Not Provided
Not Provided
 
Dose Escalation and Double-blind Study of Veliparib in Combination With Carboplatin and Etoposide in Treatment-naive Extensive Stage Disease Small Cell Lung Cancer
A Phase 1 Dose Escalation and Phase 2 Randomized Double-Blind Study of Veliparib in Combination With Carboplatin and Etoposide as a Therapy of Treatment-Naïve Extensive Stage Disease Small Cell Lung Cancer
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). ED SCLC is defined herein as any SCLC except a disease confined to the hemithorax of origin, with or without the involvement of regional lymph nodes, including ipsilateral and contralateral mediastinal, ipsilateral and contralateral mediastinal, and ipsilateral supraclavicular nodes
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Small Cell Lung Cancer
  • Drug: Veliparib
    Varying doses administered on Days -2 to 5 in a 21-day cycle
    Other Name: ABT-888
  • Drug: Carboplatin
    Administered on Day 1 via intravenous infusion in a 21-day cycle
  • Drug: Etoposide
    Administered on Days 1 to 3 via intravenous infusion in a 21-day cycle
  • Experimental: Veliparib and carboplatin and etoposide
    Veliparib in combination with carboplatin/etoposide followed by veliparib monotherapy
    Interventions:
    • Drug: Veliparib
    • Drug: Carboplatin
    • Drug: Etoposide
  • Experimental: Veliparib and carboplatin and etoposide and placebo
    Veliparib in combination with carboplatin/etoposide followed by placebo monotherapy
    Interventions:
    • Drug: Veliparib
    • Drug: Carboplatin
    • Drug: Etoposide
  • Placebo Comparator: Placebo and Carboplatin and etoposide
    Placebo in combination with carboplatin/etoposide followed by placebo monotherapy
    Interventions:
    • Drug: Carboplatin
    • Drug: Etoposide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
221
155
March 27, 2019
March 27, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subject with histologically or cytologically confirmed extensive-stage disease SCLC which is newly diagnosed and chemotherapy naive
  2. Phase 1 ONLY: histologically or cytologically confirmed advanced/metastatic solid tumors for which carboplatin/etoposide treatment is considered appropriate.
  3. Subject in Phase 2 only: must have measurable disease per RECIST 1.1.
  4. Subjects with ED SCLC must consent to provide available archived formalin fixed paraffin embedded (FFPE) tissue sample of SCLC lesion (primary or metastatic) for central review and biomarker analysis.
  5. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
  6. Subject must have adequate hematologic, renal and hepatic function.

Exclusion Criteria:

  1. Phase 1 ONLY: Subject has had any prior anti-cancer therapy other than:

    Hormonal, non-myelosuppressive, biologic, targeted, or immune therapy (must be completed ≥ 4 weeks prior to Cycle 1 Day -2).

    One line of cytotoxic chemotherapy (must be completed ≥ 4 weeks prior to Cycle 1 Day -2).

    Adjuvant/neoadjuvant radiotherapy (must be completed ≥ 12 months prior to Cycle 1 Day -2, with field not involving > 10% of bone marrow reserve).

  2. Phase 2 ONLY: Subject has had any prior chemotherapy, radiotherapy, investigational anti-cancer agents or biologic therapy for the disease under study. Single non-target lesion irradiation with intent of symptom palliation is allowed if ≥ 4 weeks prior Cycle 1 Day -2.
  3. Subject has current central nervous system (CNS) or leptomeningeal metastases or history of CNS or leptomeningeal metastases.
  4. Subject has a history of seizures within 12 months of Cycle 1 Day-2 or diagnosed neurological condition placing subject at the increased risk of seizures.
  5. Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within 14 days prior to Cycle 1 Day-2.
  6. Subject has had major surgery within 6 weeks prior to Cycle 1 Day-2 (subjects must have completely recovered from any previous surgery prior Cycle 1 Day-2).
  7. Subject has clinically significant and uncontrolled major medical condition(s) including but not limited to:

    • Uncontrolled nausea/vomiting/diarrhea;
    • Active uncontrolled infection;
    • History of hepatitis B (HBV) with surface antigen (HBsAg) positivity within 3 months prior to the date of informed consent for this study (if no test has been performed within 3 months, it must be done at screening);
    • History of hepatitis C (HCV) with HCV RNA positivity within 3 months prior to the date of informed consent for this study (if no test has been performed within 3 months it must be done at screening);
    • Symptomatic congestive heart failure (NYHA class ≥ II);
    • Unstable angina pectoris or cardiac arrhythmia (except atrial fibrillation);
    • Psychiatric illness/social situation that would limit compliance with study requirements;
    • Any other medical condition, which in the opinion of the Investigator, places the subject at an unacceptably high risk for toxicities.
  8. The subject has a history of another active cancer within the past 3 years except cervical cancer in situ, in situ carcinoma of the bladder, squamous or basal cell carcinoma of the skin or another in situ cancer that is considered cured by the investigator (e.g., in situ prostate cancer, breast DCIS).
Sexes Eligible for Study: All
18 Years to 99 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Czechia,   France,   Hungary,   Korea, Republic of,   Netherlands,   Romania,   Russian Federation,   Spain,   United States
Czech Republic
 
NCT02289690
M14-361
2014-001764-35 ( EudraCT Number )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
AbbVie
AbbVie
Not Provided
Study Director: AbbVie Inc. AbbVie
AbbVie
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP