NCT01657799

Brief Summary

The primary objective of this study is to evaluate the efficacy and safety of veliparib and whole brain radiation therapy in adults with brain metastases from non-small cell lung cancer (NSCLC).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

October 19, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2015

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

February 14, 2018

Completed
Last Updated

June 6, 2018

Status Verified

January 1, 2018

Enrollment Period

2.3 years

First QC Date

August 2, 2012

Results QC Date

January 18, 2018

Last Update Submit

May 2, 2018

Conditions

Brain Metastases From Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Overall survival was defined as the number of days from the date of randomization to the date of death. All events of death were included, regardless of whether the event occurred while the participant was still taking study treatment or after treatment was discontinued. If a participant had not died, the data were censored at the date the participant was last known to be alive.

    From randomization up to 36 months

Secondary Outcomes (3)

  • Best Tumor Response Rate

    From randomization up to 24 months

  • Time to Intracranial Progression (Radiographic)

    From randomization up to 24 months

  • Time to Clinical Brain Metastasis Progression

    From randomization up to 24 months

Study Arms (3)

Veliparib 200 mg BID + WBRT

EXPERIMENTAL

Participants received veliparib 200 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.

Drug: VeliparibRadiation: Whole brain radiation therapy

Veliparib 50 mg BID + WBRT

EXPERIMENTAL

Participants received veliparib 50 mg twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.

Drug: VeliparibRadiation: Whole brain radiation therapy

Placebo BID + WBRT

PLACEBO COMPARATOR

Participants received placebo twice a day (BID) orally concomitantly with whole brain radiation therapy (WBRT). Participants received a total of 30.0 Gy of WBRT given in 10 daily fractions of 3.0 Gy, excluding weekends and holidays.

Drug: PlaceboRadiation: Whole brain radiation therapy

Interventions

VeliparibDRUG

Veliparib capsules for oral administration

Also known as: ABT-888
Veliparib 200 mg BID + WBRTVeliparib 50 mg BID + WBRT
PlaceboDRUG

Placebo to veliparib capsules for oral administration

Placebo BID + WBRT
Whole brain radiation therapyRADIATION

30.0 grays (Gy) of WBRT given in 10 daily fractions of 3.0 Gy each, excluding weekends and holidays

Placebo BID + WBRTVeliparib 200 mg BID + WBRTVeliparib 50 mg BID + WBRT

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must have cytologically or histologically confirmed non-small cell lung cancer
  • Subject must have brain metastases demonstrated on a magnetic resonance imaging (MRI) brain scan.
  • Subject must be eligible for treatment with WBRT
  • Subject must have had adequate hematologic, renal, and hepatic function.

You may not qualify if:

  • Subject is diagnosed with brain metastases greater than 28 days prior to Day 1
  • Subject received any prior form of cranial radiation and/or neurosurgery for their brain metastases
  • Subject's last dose of anti-cancer therapy or investigational therapy was less than or equal to 7 days prior to Day 1
  • Subject has a Karnofsky Performance Score of less than 70
  • Subject has significant dyspnea requiring supplemental oxygen therapy
  • Subject has liver metastases (restaging is not required for known liver metastases)
  • Subject has more than 2 sites (organ systems) of metastases from non-small cell lung cancer with the exception of intra-cranial sites of metastases from non-small cell lung cancer, thoracic sites of metastases from non-small cell lung cancer and bone metastases
  • Subject has leptomeningeal metastases or subarachnoid spread of tumor
  • Subject has unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment
  • Subject has a known seizure disorder that is uncontrolled, or has seizures occurring greater than or equal to 3 times a week over the past month. Subjects presenting with symptoms of seizures from the brain metastases are eligible; however he/she should receive adequate anti-seizure medication prior to study treatment
  • Subject is pregnant or lactating
  • Subject has previously been treated with a poly-(ADP-ribose)-polymerase inhibitor as an investigational agent
  • Subject has clinically significant and uncontrolled major medical condition(s)
  • Subject has a history of another active cancer within the past 5 years except: cervical cancer in situ, in situ carcinoma of the bladder, basal or squamous cell carcinoma of the skin or other cancer in situ that is considered cured

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chabot P, Hsia TC, Ryu JS, Gorbunova V, Belda-Iniesta C, Ball D, Kio E, Mehta M, Papp K, Qin Q, Qian J, Holen KD, Giranda V, Suh JH. Veliparib in combination with whole-brain radiation therapy for patients with brain metastases from non-small cell lung cancer: results of a randomized, global, placebo-controlled study. J Neurooncol. 2017 Jan;131(1):105-115. doi: 10.1007/s11060-016-2275-x. Epub 2016 Sep 21.

    PMID: 27655223RESULT

MeSH Terms

Interventions

veliparib

Results Point of Contact

Title
Global Medical Services
Organization
AbbVie
800-633-9110

Study Officials

  • Vincent Giranda, MD

    AbbVie

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2012

First Posted

August 6, 2012

Study Start

October 19, 2012

Primary Completion

January 22, 2015

Study Completion

January 22, 2015

Last Updated

June 6, 2018

Results First Posted

February 14, 2018

Record last verified: 2018-01