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Closed (no longer recruiting)Last updated: 21 December 2023

M14-361: This phase I trial is combining an anti-cancer drug (veliparib) with chemotherapy (carboplatin and etoposide) for the treatment of patients with extensive-stage Small Cell Lung Cancer (SCLC)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-Naive Extensive Stage Disease Small Cell Lung Cancer

Clinical summary

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

Conditions

This trial is treating patients with Extensive Disease Small Cell Lung Cancer (ED SCLC).

Cancer

Lung Cancers Lung cancer

Age

People18 - 99

Phase

I

Trial Acronym

M14-361

More information

Trial Identifiers

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Trial sponsor

AbbVie

Scientific 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-Naive Extensive Stage Disease Small Cell Lung Cancer

Eligibility

Inclusion

  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

  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 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.
  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).

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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