Summary

for people ages 18-99 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination with concurrent Paclitaxel/Carboplatin-based chemoradiotherapy and consolidation with Paclitaxel/Carboplatin-based chemotherapy (Phase 1 portion) and to assess whether the addition of oral veliparib versus placebo to Paclitaxel/Carboplatin-based chemoradiotherapy with Paclitaxel/Carboplatin consolidation will improve progression-free survival (PFS) in subjects with Stage III non-small cell lung cancer (Phase 2 portion).

Official Title

A Phase 1 Dose Escalation and Phase 2 Randomized, Placebo-Controlled Study of the Efficacy and Tolerability of Veliparib in Combination With Paclitaxel/Carboplatin-Based Chemoradiotherapy Followed by Veliparib and Paclitaxel/Carboplatin Consolidation in Subjects With Stage III Non-Small Cell Lung Cancer (NSCLC)

Keywords

Non-small Cell Lung Cancer Stage III veliparib PARP inhibitor ABT-888 first line previously untreated stage III non-small cell lung cancer radiotherapy paclitaxel carboplatin Lung Neoplasms Carcinoma, Non-Small-Cell Lung Albumin-Bound Paclitaxel RT + Carbo/Pac + Veliparib followed by Carbo/Pac + Veliparib

Eligibility

You can join if…

Open to people ages 18-99

  1. Participants with Histologically or cytologically confirmed Stage III non-small cell lung cancer (NSCLC).
  2. Participants in the randomized portion of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 criteria.
  3. Participants must have V20 (volume of lung to receive 20 Gy radiotherapy according to simulation) < 35%.
  4. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1.
  5. Participant must have adequate hematologic, renal, hepatic, and lung function.
  6. Participant must consent to provide archived tissue or cytology sample of NSCLC lesion for analysis.

You CAN'T join if...

  1. Participants with prior chemotherapy or radiotherapy (RT) for current NSCLC.Participants curatively treated for past early stage NSCLC greater than 3 years ago may be included.
  2. Participants with prior exposure to poly-ADP-ribose polymerase (PARP) inhibitors.
  3. Participants with known hypersensitivity to carboplatin, paclitaxel, or formulations containing polyethoxylated castor oil (Cremophor).
  4. Participants with prior mediastinal or thoracic radiotherapy. Prior tangential RT to prior breast cancer is acceptable.
  5. Participants with major surgery in the 4 weeks prior to randomization (Video-assisted thoracoscopic surgery (VATS) and/or mediastinoscopy is not considered major surgery).
  6. Participants with a previous or concurrent malignancy except for treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient received potentially curative treatment and has been disease-free for 3 years or is considered cured by the investigator if has been disease-free for less than 3 years.
  7. Participant is pregnant or lactating.
  8. Participant with sensory peripheral neuropathy of ≥ Grade 2 at baseline, unable to swallow medication, or participants with prior history of seizure within the prior 12 months.

Locations

  • UCSD
    La Jolla California 92037 United States
  • University of Chicago
    Chicago Illinois 60637-1443 United States
  • Wake Forest Univ HS
    Winston-Salem North Carolina 27157 United States
  • UNC
    Chapel Hill North Carolina 27599 United States
  • Duke Univ Med Ctr
    Durham North Carolina 27710 United States
  • University of Virginia
    Charlottesville Virginia 22908 United States
  • Univ Maryland School Medicine
    Baltimore Maryland 21201 United States
  • SUNY Upstate Medical Center
    Syracuse New York 13210 United States
  • Christiana Care Health Service
    Newark Delaware 19713 United States
  • Rhode Island Hospital
    Providence Rhode Island 02905 United States
  • The Miriam Hospital
    Providence Rhode Island 02906 United States
  • Dana-Farber Cancer Institute
    Boston Massachusetts 02215 United States
  • Hosp Univ Fundacion Alcorcon
    Alcorcon 28922 Spain
  • Hosp. Sta Creu i Sant Pau
    Barcelona 08025 Spain
  • Hospital Universitario Vall d´
    Barcelona 08035 Spain
  • Hospital General Universitario Gregorio Maranon
    Madrid 28009 Spain
  • Fundacion Jimenez Diaz
    Madrid 28040 Spain
  • Hosp Univ 12 de Octubre
    Madrid 28041 Spain
  • Hosp Univ Madrid Sanchinarro
    Madrid 28050 Spain
  • Hosp Clin Univ de Valencia
    Valencia 46010 Spain
  • Masarykuv onkologikcy ustav
    Brno 656 53 Czechia
  • Krajska nemocnice Liberec a.s.
    Liberec 46063 Czechia
  • Nemocnice Novy Jicin
    Nový Jicín 741 01 Czechia
  • Nemocnice Na Bulovce
    Prague 8 - Liben 180 81 Czechia
  • Genl Hosp Athens Gennimatas
    Athens 115 27 Greece
  • Metropolitan Hospital
    Athens 18547 Greece
  • Papageorgiou Hospital
    NEA Efkarpia 56403 Greece
  • University Gen Hosp of Patra
    Patras 26504 Greece
  • Bioclinic Thessaloniki
    Thessaloniki 54622 Greece
  • Euromedica General Clinic
    Thessaloniki 54645 Greece

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02412371
Phase
Phase 1/2
Study Type
Interventional
Last Updated
June 6, 2018