Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung Cancer

NCT ID: NCT01657799

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-19
• Study Completion Date: 2015-01-22

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).

Conditions

Brain Metastases From Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Veliparib 200 mg BID + WBRT

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.

Group Type: EXPERIMENTAL

Veliparib

Intervention Type: DRUG

Veliparib capsules for oral administration

Whole brain radiation therapy

Intervention Type: RADIATION

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

Veliparib 50 mg BID + WBRT

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.

Group Type: EXPERIMENTAL

Veliparib

Intervention Type: DRUG

Veliparib capsules for oral administration

Whole brain radiation therapy

Intervention Type: RADIATION

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

Placebo BID + WBRT

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to veliparib capsules for oral administration

Whole brain radiation therapy

Intervention Type: RADIATION

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

Interventions

Veliparib

Veliparib capsules for oral administration

Intervention Type: DRUG

Placebo

Placebo to veliparib capsules for oral administration

Intervention Type: DRUG

Whole brain radiation therapy

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

Intervention Type: RADIATION

Other Intervention Names

ABT-888

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent Giranda, MD

Role: STUDY_DIRECTOR

AbbVie

References

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.

Reference Type: RESULT

PMID: 27655223 (View on PubMed)

Other Identifiers

2011-003618-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M10-897

Identifier Type: -

Identifier Source: org_study_id