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A Study Evaluating 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

This study is currently recruiting participants.
Verified July 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT02412371
First Posted: April 9, 2015
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
  Purpose
This study seeks to establish the recommended Phase 2 dose (RPTD) of veliparib in combination with concurrent Paclitaxel/Carboplatin-based chemoradiotherapy (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).

Condition Intervention Phase
Non-small Cell Lung Cancer Stage III Drug: Veliparib Drug: Paclitaxel Drug: Carboplatin Radiation: Radiotherapy Other: Placebo for Veliparib Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Recommended Phase 2 dose (RPTD) of veliparib (ABT-888) in combination with radiotherapy, paclitaxel and carboplatin [ Time Frame: Approximately 2 years ]
    Recommended Phase 2 dose (RPTD) in combination with radiotherapy, paclitaxel and carboplatin will be determined by dose escalation in phase 1 of the study. Dose limiting toxicity (DLT) events will be collected for each dosing cohort until a new dosing cohort is opened or until the recommended Phase 2 dose is identified.

  • Progression-free survival (PFS) [ Time Frame: Approximately 3 years ]
    Progression-free survival (PFS) is defined as the number of days from the date of enrollment to the date of earliest progression or death. If the participant does not experience disease progression or death, then the data will be censored at the date of the last disease assessment.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Approximately 3 years ]
    Overall survival is defined as the number of days from the date of participant enrollment to the date of death.

  • Objective Response Rate (ORR) [ Time Frame: Approximately every 8 weeks from first dose until one year after beginning therapy, then every 12 weeks for up to 3 years. ]
    Objective Response Rate (ORR) is defined as the proportion of the participants who have a complete response (CR) or partial response (PR).

  • Duration of Overall Response (DOR) [ Time Frame: Approximately every 8 weeks from first dose until one year after beginning therapy, then every 12 weeks for up to 3 years. ]
    Duration of Overall Response (DOR) is defined as the time from the participant's initial CR or PR to the time of disease progression.


Other Outcome Measures:
  • Quality of Life (QoL) [ Time Frame: Until a participant achieves 1 year on treatment (for participants in phase 2 only) ]
    Two short cancer questionnaires by the European Organization for Research and Treatment of Cancer (EORTC) will be used to measure change in a participant's quality of life.

  • Change in ECOG (Eastern Cooperative Oncology Group) Performance Status of Participants [ Time Frame: Approximately 3 years ]

Estimated Enrollment: 186
Study Start Date: April 30, 2015
Estimated Study Completion Date: November 22, 2020
Estimated Primary Completion Date: September 3, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RT + Carbo/Pac + Veliparib followed by Carbo/Pac + Veliparib
This arm, concurrent radiotherapy (RT) + carboplatin (Carbo)/Paclitaxel (Pac) + veliparib followed by consolidation of Carbo/Pac + veliparib, is for both the Phase 1/dose escalation and Phase 2 portion of the study.
Drug: Veliparib
Oral capsule of varying doses
Other Name: ABT-888
Drug: Paclitaxel
Administered via intravenous infusion on Day 1 of each treatment week/cycle.
Drug: Carboplatin
Administered via intravenous infusion on Day 1 of each treatment week/cycle.
Radiation: Radiotherapy
Radiation treatment administered on Day 1 through Day 5 of each week for approximately 30-34 visits.
Experimental: RT + Carbo/Pac + Veliparib followed by Carbo/Pac + Placebo
This arm, concurrent radiotherapy (RT) + carboplatin (Carbo)/Paclitaxel (Pac) + veliparib followed by consolidation of Carbo/Pac + Placebo, is for the Phase 2 portion of the study.
Drug: Veliparib
Oral capsule of varying doses
Other Name: ABT-888
Drug: Paclitaxel
Administered via intravenous infusion on Day 1 of each treatment week/cycle.
Drug: Carboplatin
Administered via intravenous infusion on Day 1 of each treatment week/cycle.
Radiation: Radiotherapy
Radiation treatment administered on Day 1 through Day 5 of each week for approximately 30-34 visits.
Other: Placebo for Veliparib
Oral capsule of varying doses
Placebo Comparator: RT + Carbo/Pac + Placebo followed by Carbo/Pac + Placebo
This arm, concurrent radiotherapy (RT) + carboplatin (Carbo)/Paclitaxel (Pac) + placebo followed by consolidation of Carbo/Pac + placebo, is for the Phase 2 portion of the study.
Drug: Paclitaxel
Administered via intravenous infusion on Day 1 of each treatment week/cycle.
Drug: Carboplatin
Administered via intravenous infusion on Day 1 of each treatment week/cycle.
Radiation: Radiotherapy
Radiation treatment administered on Day 1 through Day 5 of each week for approximately 30-34 visits.
Other: Placebo for Veliparib
Oral capsule of varying doses

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  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.

Exclusion Criteria:

  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.
  Contacts and Locations
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): NCT02412371


Contacts
Contact: AbbVie_Call Center 847-283-8955 abbvieclinicaltrials@abbvie.com

Locations
United States, California
UCSD Moores Cancer Center, US /ID# 133037 Recruiting
La Jolla, California, United States, 92093-0698
United States, Delaware
Medical Oncology Hematology Consultants, PA /ID# 133486 Recruiting
Newark, Delaware, United States, 19713
United States, Illinois
The University of Chicago Medical Center /ID# 133828 Recruiting
Chicago, Illinois, United States, 60637
United States, Maryland
University of Maryland School of Medicine /ID# 132944 Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana Farber Cancer Institute /ID# 133494 Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Hilltop Radiation Oncology /ID# 134438 Recruiting
Syracuse, New York, United States, 13210
SUNY Upstate Medical Center /ID# 133492 Recruiting
Syracuse, New York, United States, 13210
United States, North Carolina
University of North Carolina at Chapel Hill /ID# 133496 Recruiting
Chapel Hill, North Carolina, United States, 27599-7305
Duke Cancer Center /ID# 133497 Recruiting
Durham, North Carolina, United States, 27710
Wake Forest Baptist Health /ID# 134608 Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Rhode Island
Rhode Island Hospital /ID# 133493 Recruiting
Providence, Rhode Island, United States, 02903
The Miriam Hospital /ID# 133910 Not yet recruiting
Providence, Rhode Island, United States, 02903
United States, Texas
The University of Texas - MD Anderson Cancer Center /ID# 141321 Withdrawn
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Health System /ID# 133495 Recruiting
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Mark D McKee, MD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02412371     History of Changes
Other Study ID Numbers: M14-360
2016-001659-32 ( EudraCT Number )
First Submitted: November 6, 2014
First Posted: April 9, 2015
Last Update Posted: July 11, 2017
Last Verified: July 2017

Keywords provided by AbbVie:
previously untreated
PARP inhibitor
radiotherapy
paclitaxel
ABT-888
stage III
first line
carboplatin
veliparib
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Veliparib
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors