Clinical Trials List
Protocol NumberM10-897
2012-09-01 - 2016-09-01
Phase II
Terminated6
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
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
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Trial Applicant
AbbVie
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Sponsor
AbbVie
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chia-Chi Lin Division of Hematology & Oncology
- JIN-YUAN SHIH Division of General Internal Medicine
- 吳佩芳 醫研部
- 林育麟 Division of Hematology & Oncology
- 陳冠宇 Division of General Internal Medicine
- Chong-Jen Yu Division of General Internal Medicine
- 廖唯昱 Division of General Internal Medicine
- Jih-Hsiang Lee Division of Hematology & Oncology
- CHAO-CHI HO CHAO-CHI HO Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Shang-Yin Wu Division of Hematology & Oncology
- Chia-Jui Yen Division of Hematology & Oncology
- 陳海雯 Division of Radiation Therapy
- Wen-Pin Su Division of Hematology & Oncology
- 謝函潔 Division of Neurology
- 李榮順 Division of Orthopedics
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- JENG-SEN TSENG Division of Thoracic Medicine
- TSUNG -YING YANG Division of Thoracic Medicine
- KUO-HSUAN HSU Division of Thoracic Medicine
- 陳焜結 Division of Thoracic Medicine
- PO-LIN CHEN Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Wan Yuo Wan Yuo Division of Radiology
- 藍耿立 Division of Radiation Therapy
- Chao-Hua Chiu Division of Thoracic Medicine
- Yuh-Min Chen Division of Thoracic Medicine
- 李怡慧 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Tsu-Yi Chao Division of Hematology & Oncology
- 林群書 Division of Radiation Therapy
- 陳宇欽 Division of Hematology & Oncology
- 徐昌鴻 Division of Neurology
- 戴明燊 Division of Hematology & Oncology
- 黃子權 Division of Hematology & Oncology
- 張平穎 Division of Hematology & Oncology
- 高偉堯 Division of Hematology & Oncology
- TSU-YI CHAO Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chih-Yen Tu Division of Thoracic Medicine
- Wei-Shih Huang Division of Neurology
- 陳鴻仁 Division of Thoracic Medicine
- Ming-Kuei Lu Division of Neurology
- Chun-Ru Chien Division of Radiation Therapy
- Chen Chia-Hung Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Brain Metastases from Non-Small Cell Lung Cancer
Objectives
The objectives of this study are to evaluate the efficacy and safety of veliparib when given
during whole brain radiation therapy (WBRT). The efficacy evaluation includes comparing Overall Survival, Best Tumor Response Rate, Time to Clinical Brain Metastases Progression, and Time to Intracranial Progression (Radiographic) between each of the veliparib and WBRT groups (200 mg BID veliparib and WBRT or 50 mg BID veliparib and WBRT) and the placebo BID and WBRT group. The study will also evaluate the effects of veliparib and WBRT on Karnofsky Performance Status, Quality of Life, and Activities of Daily Living.
Test Drug
ABT-888 (Veliparib)
Active Ingredient
ABT-888 (Veliparib)
Dosage Form
Dosage
100 ; 50
Endpoints
Primary Efficacy Endpoint:
The primary efficacy endpoint is overall survival.
Secondary Efficacy Endpoints:
Secondary efficacy analyses comparing the effects of veliparib 50 mg BID and WBRT
versus placebo BID and WBRT as well as veliparib 200 mg BID and WBRT versus
placebo BID and WBRT on the following set of endpoints will also be performed: best
tumor response rate, time to clinical brain metastasis progression, time to intracranial
progression (radiographic).
The primary efficacy endpoint is overall survival.
Secondary Efficacy Endpoints:
Secondary efficacy analyses comparing the effects of veliparib 50 mg BID and WBRT
versus placebo BID and WBRT as well as veliparib 200 mg BID and WBRT versus
placebo BID and WBRT on the following set of endpoints will also be performed: best
tumor response rate, time to clinical brain metastasis progression, time to intracranial
progression (radiographic).
Inclution Criteria
Main Inclusion Criteria:
Subject must be ≥ 18 years of age;
Subject must have cytologically or histologically confirmed NSCLC;
Subject must have brain metastases demonstrated on a MRI brain scan;
Subject must be eligible for treatment with WBRT;
Subject must have adequate hematologic, renal, and hepatic function as follows:
o Absolute Neutrophil Count (ANC > 1,000/mm3 [1.0 × 109/L]);
o Platelets > 100,000/mm3 (100 × 109/L);
o Hemoglobin > 9.0 g/dL (1.4 mmol/L);
o Serum creatinine < 1.5 × upper normal limit (ULN) OR creatinine clearance > 45mL/min/1.73m2 for subjects with creatinine levels above the ULN;
o AST and/or ALT < 2.5 × the ULN;
o Bilirubin < 1.5 × the ULN. Subjects with Gilbert's Syndrome may have a bilirubin ≥ 1.5 × the ULN.
Women of childbearing potential and men must agree to use adequate contraception prior to study entry (sufficiently long enough to ensure prevention of pregnancy) for the duration of study participation and for a minimum of 90 days following completion of therapy. Women of childbearing potential must have a negative serum pregnancy test prior to initiation of treatment. To be considered of non-child bearing potential, postmenopausal women must be amenorrheic for at least 12 months or subjects must be surgically sterile. Adequate means of contraception are considered to be:
o Total abstinence from sexual intercourse as the preferred life style, periodic abstinence is
not acceptable;
o Vasectomized male subjects or vasectomized partner of female subjects; a vasectomized
partner of female subjects must be an exclusive partner;
o Hormonal contraceptives (oral, vaginal ring, parenteral or transdermal);
o Double-barrier method (condoms and diaphragm or vaginal cap plus spermicidal sponge,
jellies or cream);
o Intra-Uterine Device (IUD).
Note: Additionally, male subjects (including those who are vasectomized) with partners of
childbearing potential, must agree to use condoms for the duration of the Treatment Period and for 90 days following completion of therapy.
Subject must be able to take oral medication.
Subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Subject must be ≥ 18 years of age;
Subject must have cytologically or histologically confirmed NSCLC;
Subject must have brain metastases demonstrated on a MRI brain scan;
Subject must be eligible for treatment with WBRT;
Subject must have adequate hematologic, renal, and hepatic function as follows:
o Absolute Neutrophil Count (ANC > 1,000/mm3 [1.0 × 109/L]);
o Platelets > 100,000/mm3 (100 × 109/L);
o Hemoglobin > 9.0 g/dL (1.4 mmol/L);
o Serum creatinine < 1.5 × upper normal limit (ULN) OR creatinine clearance > 45mL/min/1.73m2 for subjects with creatinine levels above the ULN;
o AST and/or ALT < 2.5 × the ULN;
o Bilirubin < 1.5 × the ULN. Subjects with Gilbert's Syndrome may have a bilirubin ≥ 1.5 × the ULN.
Women of childbearing potential and men must agree to use adequate contraception prior to study entry (sufficiently long enough to ensure prevention of pregnancy) for the duration of study participation and for a minimum of 90 days following completion of therapy. Women of childbearing potential must have a negative serum pregnancy test prior to initiation of treatment. To be considered of non-child bearing potential, postmenopausal women must be amenorrheic for at least 12 months or subjects must be surgically sterile. Adequate means of contraception are considered to be:
o Total abstinence from sexual intercourse as the preferred life style, periodic abstinence is
not acceptable;
o Vasectomized male subjects or vasectomized partner of female subjects; a vasectomized
partner of female subjects must be an exclusive partner;
o Hormonal contraceptives (oral, vaginal ring, parenteral or transdermal);
o Double-barrier method (condoms and diaphragm or vaginal cap plus spermicidal sponge,
jellies or cream);
o Intra-Uterine Device (IUD).
Note: Additionally, male subjects (including those who are vasectomized) with partners of
childbearing potential, must agree to use condoms for the duration of the Treatment Period and for 90 days following completion of therapy.
Subject must be able to take oral medication.
Subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign and date the informed consent approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
Exclusion Criteria
Main Exclusion Criteria:
Subject is diagnosed with brain metastases ≥ 21 days prior to Treatment 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 (brain directed or systemic therapies) was ≤ 7 days prior to Treatment Day 1. Subjects may continue to receive bisphosphonates, steroids such as inhaled steroids for asthma, topical steroids, or
replacement/stress corticosteroids, and medroxyprogesterone during the study if started prior to treatment with veliparib/placebo and WBRT;
Subject has a Karnofsky Performance Score (KPS) of < 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 NSCLC (restaging is not
required for subjects with more than 2 known sites of metastases) with the exception of the
following:
o Intra-cranial sites of metastases from NSCLC;
o Thoracic sites of metastases from NSCLC; and
o Bone metastases.
Subject has leptomeningeal metastases or subarachnoid spread of tumor as demonstrated on a MRI brain scan;
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 PARP inhibitor as an investigational agent;
Subject has clinically significant and uncontrolled major medical condition(s) including but not limited to:
o Uncontrolled nausea/vomiting/diarrhea.
o Active uncontrolled infection requiring intravenous antibiotics;
o Non-cancer related neurologic or neurodegenerative condition;
o Symptomatic congestive heart failure;
o Unstable angina pectoris or cardiac arrhythmia;
o Psychiatric illness/social situation that would limit compliance with study requirements;
o Any medical condition, which in the opinion of the Investigator, places the subject at an
unacceptably high risk for toxicities;
o Fluid retention, including ascites or pleural effusion, may be allowed at the discretion of the Investigator.
Subject has a history of another active cancer within the past 5 years except:
o Cervical cancer in situ
o In situ carcinoma of the bladder;
o Basal or squamous cell carcinoma of the skin; or
o Other cancer in situ that is considered cured.
Subject is diagnosed with brain metastases ≥ 21 days prior to Treatment 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 (brain directed or systemic therapies) was ≤ 7 days prior to Treatment Day 1. Subjects may continue to receive bisphosphonates, steroids such as inhaled steroids for asthma, topical steroids, or
replacement/stress corticosteroids, and medroxyprogesterone during the study if started prior to treatment with veliparib/placebo and WBRT;
Subject has a Karnofsky Performance Score (KPS) of < 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 NSCLC (restaging is not
required for subjects with more than 2 known sites of metastases) with the exception of the
following:
o Intra-cranial sites of metastases from NSCLC;
o Thoracic sites of metastases from NSCLC; and
o Bone metastases.
Subject has leptomeningeal metastases or subarachnoid spread of tumor as demonstrated on a MRI brain scan;
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 PARP inhibitor as an investigational agent;
Subject has clinically significant and uncontrolled major medical condition(s) including but not limited to:
o Uncontrolled nausea/vomiting/diarrhea.
o Active uncontrolled infection requiring intravenous antibiotics;
o Non-cancer related neurologic or neurodegenerative condition;
o Symptomatic congestive heart failure;
o Unstable angina pectoris or cardiac arrhythmia;
o Psychiatric illness/social situation that would limit compliance with study requirements;
o Any medical condition, which in the opinion of the Investigator, places the subject at an
unacceptably high risk for toxicities;
o Fluid retention, including ascites or pleural effusion, may be allowed at the discretion of the Investigator.
Subject has a history of another active cancer within the past 5 years except:
o Cervical cancer in situ
o In situ carcinoma of the bladder;
o Basal or squamous cell carcinoma of the skin; or
o Other cancer in situ that is considered cured.
The Estimated Number of Participants
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Taiwan
60 participants
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Global
300 participants
