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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

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Small Cell Lung Cancer

Intervention: Veliparib (Drug); Carboplatin (Drug); Etoposide (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: AbbVie

Official(s) and/or principal investigator(s):
Philip Komarnitsky, MD, Study Director, Affiliation: AbbVie

Overall contact:
Lindsey Rosenwinkel, BS, Phone: 847-937-6985, Email: lindsey.rosenwinkel@abbvie.com

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

Clinical Details

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-Nave Extensive Stage Disease Small Cell Lung Cancer

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Maximum tolerated dose (MTD) of veliparib (ABT-888) in combination with carboplatin and etoposide

Recommended Phase 2 dose of veliparib (ABT-888) in combination with carboplatin and etoposide

Secondary outcome: Frequency of adverse events during maintenance veliparib monotherapy at 400 mg twice daily (BID)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

Lindsey Rosenwinkel, BS, Phone: 847-937-6985, Email: lindsey.rosenwinkel@abbvie.com

Site Reference ID/Investigator# 132883, Edmonton T6G 1Z2, Canada; Recruiting
Site Reference ID/Investigator# 132883, Principal Investigator

Site Reference ID/Investigator# 131252, Groningen 9713 GZ, Netherlands; Recruiting
Site Reference ID/Investigator# 131252, Principal Investigator

Site Reference ID/Investigator# 134719, Nijmegen 6525 GA, Netherlands; Not yet recruiting
Site Reference ID/Investigator# 134719, Principal Investigator

Site Reference ID/Investigator# 131251, Rotterdam 3075 EA, Netherlands; Recruiting
Site Reference ID/Investigator# 131251, Principal Investigator

Site Reference ID/Investigator# 130302, Barcelona 08028, Spain; Recruiting
Site Reference ID/Investigator# 130302, Principal Investigator

Site Reference ID/Investigator# 130301, Madrid 28050, Spain; Recruiting
Site Reference ID/Investigator# 130301, Principal Investigator

Site Reference ID/Investigator# 129220, Aurora, Colorado 80045, United States; Recruiting
Site Reference ID/Investigator# 129220, Principal Investigator

Site Reference ID/Investigator# 129214, Durham, North Carolina 27710, United States; Not yet recruiting
Site Reference ID/Investigator# 129214, Principal Investigator

Site Reference ID/Investigator# 129216, Canton, Ohio 44718, United States; Recruiting
Site Reference ID/Investigator# 129216, Principal Investigator

Site Reference ID/Investigator# 129213, Houston, Texas 77030, United States; Not yet recruiting
Site Reference ID/Investigator# 129213, Principal Investigator

Additional Information

Starting date: October 2014
Last updated: July 15, 2015

Page last updated: August 23, 2015

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