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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

Brief 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). 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

Condition or disease Intervention/treatment Phase
Small Cell Lung Cancer Drug: Veliparib Drug: Carboplatin Drug: Etoposide Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 13, 2014
Estimated Primary Completion Date : March 27, 2019
Estimated Study Completion Date : March 27, 2019


Arm Intervention/treatment
Experimental: Veliparib and carboplatin and etoposide
Veliparib in combination with carboplatin/etoposide followed by veliparib monotherapy
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 and placebo
Veliparib in combination with carboplatin/etoposide followed by placebo monotherapy
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

Placebo Comparator: Placebo and Carboplatin and etoposide
Placebo in combination with carboplatin/etoposide followed by placebo monotherapy
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




Primary Outcome Measures :
  1. Recommended Phase 2 dose of veliparib (ABT-888) in combination with carboplatin and etoposide [ Time Frame: Approximately 2 years ]
  2. Maximum tolerated dose (MTD) of veliparib (ABT-888) in combination with carboplatin and etoposide [ Time Frame: Approximately 2 years ]

Secondary Outcome Measures :
  1. Frequency of adverse events during maintenance veliparib monotherapy at 400 mg twice daily (BID) [ Time Frame: Approximately 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289690


  Show 62 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02289690     History of Changes
Other Study ID Numbers: M14-361
2014-001764-35 ( EudraCT Number )
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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

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

Keywords provided by AbbVie:
Extensive Stage Smal Cell Lung Cancer
ABT-888
Veliparib
PARP - Poly (ADP) ribose polymerase

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Etoposide phosphate
Veliparib
Carboplatin
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors