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

AbbVie

Status and phase: Completed; Phase 2

Conditions: Brain Metastases From Non-small Cell Lung Cancer

Treatments: Drug: Placebo; Radiation: Whole brain radiation therapy; Drug: Veliparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01657799

2011-003618-18 (EudraCT Number)

M10-897

Details and patient eligibility

About

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).

Enrollment: 307 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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307 participants in 3 patient groups, including a placebo group

Veliparib 200 mg BID + WBRT

Experimental group

Description:

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.

Treatment:

Drug: Veliparib

Radiation: Whole brain radiation therapy

Veliparib 50 mg BID + WBRT

Experimental group

Description:

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.

Treatment:

Drug: Veliparib

Radiation: Whole brain radiation therapy

Placebo BID + WBRT

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Radiation: Whole brain radiation therapy