Clinical trial · Interventional
Comparison of Veliparib and Whole Brain Radiation Therapy (WBRT) Versus Placebo and WBRT in Adults With Brain Metastases From Non-Small Cell Lung Cancer
A Randomized, Double-Blind, Phase 2, Dose-Ranging Study to Evaluate the Safety and Efficacy of Veliparib and Whole Brain Radiation Therapy Versus Placebo and Whole Brain Radiation Therapy in Subjects With Brain Metastases From Non-Small Cell Lung Cancer
NCT01657799CI-TRIAL-00033212completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases From Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Veliparib | Drug | Veliparib | ALIAS |
| Whole brain radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Veliparib 200 mg BID + WBRT
- 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.
- interventionNames
- Drug: Veliparib
- Radiation: Whole brain radiation therapy
- type
- EXPERIMENTAL
- label
- Veliparib 50 mg BID + WBRT
- 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.
- interventionNames
- Drug: Veliparib
- Radiation: Whole brain radiation therapy
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTChabot 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 27655223