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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Small Cell Lung Cancer

In brief

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).

Key facts

Study ID

NCT02289690

Run by

AbbVie

People needed

221

Starts

2014-10-13

Expected to finish

2019-04-17

Last updated by the study team

2020-05-14

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject with histologically or cytologically confirmed extensive-stage disease SCLC which is newly diagnosed and chemotherapy naive
• Phase 1 ONLY: histologically or cytologically confirmed advanced/metastatic solid tumors for which carboplatin/etoposide treatment is considered appropriate.
• Subject in Phase 2 only: must have measurable disease per RECIST 1.1.
• 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.
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
• Subject must have adequate hematologic, renal and hepatic function.

You may not qualify if…

• 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).
• 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.
• Subject has current central nervous system (CNS) or leptomeningeal metastases or history of CNS or leptomeningeal metastases.
• 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.
• Subject has received anti-cancer Chinese medicine or anti-cancer herbal remedies within 14 days prior to Cycle 1 Day-2.
• 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).
• 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 ribonucleic acid (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 (Yew York Heart Association [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.
• 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).

Where it is running

• Univ of Colorado Cancer Center /ID# 129220 — Aurora, Colorado, United States
• Emory University Hospital /ID# 141682 — Atlanta, Georgia, United States
• Georgia Regents University /ID# 148567 — Augusta, Georgia, United States
• Northwestern University Feinberg School of Medicine /ID# 137088 — Chicago, Illinois, United States
• Herbert Herman Cancer Center /ID# 167020 — Lansing, Michigan, United States
• Gabrail Cancer Center Research /ID# 129216 — Canton, Ohio, United States
• Allegheny General Hospital /ID# 147328 — Pittsburgh, Pennsylvania, United States
• University of Texas MD Anderson Cancer Center /ID# 129213 — Houston, Texas, United States
• Southern Medical Day Care Ctr /ID# 155498 — Wollongong, New South Wales, Australia
• The Townsville Hospital /ID# 155499 — Douglas, Queensland, Australia
• Peninsula & South Eastern Haem /ID# 155497 — Frankston, Victoria, Australia
• Border Medical /ID# 157894 — Wodonga, Victoria, Australia
• Cliniques Universitaires Saint Luc /ID# 151024 — Woluwe-Saint-Lambert, Brussels Capital, Belgium
• CHU de Liege /ID# 151025 — Liège, Liege, Belgium
• UZ Antwerp /ID# 151026 — Edegem, Belgium
• C.H.U.de Mons Borinage /ID# 151023 — Mons, Belgium
• CHU UCL Namur /ID# 151022 — Namur, Belgium
• University of Calgary /ID# 152544 — Calgary, Alberta, Canada
• Cross Cancer Institute /ID# 132883 — Edmonton, Alberta, Canada
• Juravinski Cancer Clinic /ID# 152543 — Hamilton, Ontario, Canada
• Hopital du Sacre Coeur Montreal /ID# 154436 — Montreal, Quebec, Canada
• Nemocnice Na Plesi s.r.o. /ID# 149825 — Nová Ves pod Pleší, Pribram, Czechia
• Nemocnice Novy Jicin /ID# 149838 — Nový Jičín, Czechia
• Vitkovicka nemocnice a. s. /ID# 149839 — Ostrava, Czechia
• Mayo Clinic - Scottsdale /ID# 129127 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.