A Phase I Study of ABT-888 in Combination With Conventional Whole Brain Radiation Therapy (WBRT) in Cancer Patients With Brain Metastases
NCT ID: NCT00649207
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2008-03-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
This is an open label study; therefore, there are no numbered/labeled study arms.
This is a dose escalation study, ABT-888 dose will be escalated in conjunction with two schedules of whole brain radiation therapy (WBRT). Subjects may be treated WBRT for 3 weeks (15 days) or 2 weeks (10 days).
ABT-888
Oral Capsules
Whole Brain Radiation Therapy
15 fractions of 2.5 Gy over 3 weeks to a total dose of 37.5 GY or 10 fractions of 3.0 Gy over 2 weeks to a total dose of 30 Gy
Interventions
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ABT-888
Oral Capsules
Whole Brain Radiation Therapy
15 fractions of 2.5 Gy over 3 weeks to a total dose of 37.5 GY or 10 fractions of 3.0 Gy over 2 weeks to a total dose of 30 Gy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed non-CNS primary solid malignancy.
* Pathologically or radiographically confirmed metastatic disease in the brain. Subjects with non-measurable lesions, including leptomeningeal carcinomatosis, are eligible.
* WBRT is clinically indicated, with the exception of prophylactic treatment.
* Karnofsky Performance Status (KPS) greater than or equal to a score of 70.
* Adequate hematology, renal and hepatic function.
* Both men and women of childbearing potential must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and up to 2 months following completion of protocol therapy.
* Total abstinence from sexual intercourse (minimum one complete menstrual cycle)
* A vasectomized partner \* Hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration
* Double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or cream)
* Subject is capable of understanding and complying with parameters as outlined in the protocol.
* Subject or the subject's legally acceptable representative has voluntarily signed and dated 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
* Primary central nervous system (CNS) neoplasm.
* Prior or concurrent administration of the following therapies or treatments:
* Prior treatment with WBRT
* SRS performed less than 14 days prior to WBRT D1, or is scheduled to occur within 30 days of the last WBRT session
* Last dose of chemotherapy, immunotherapy, biologic therapy, or investigational therapy was less than 14 days prior to WBRT D1. Bisphosphonates, hormone modification therapy, and trastuzumab are permitted without restriction
* Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment.
* Known seizure disorder (status epileptics) that is uncontrolled, or seizures occurring greater than or equal to 3 times a week over the past month.
* If female, subject is pregnant or breast-feeding.
* Clinically significant and uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or neurological/psychiatric disease or disorder, including but not limited to:
* Active uncontrolled infection
* Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
* Any other illness condition(s) that could exacerbate potential toxicities, confound safety assessments, require excluded therapy for management, or limit compliance with study requirements
* Unable to swallow and retain oral medications.
* Known contraindication to enhanced MRI and CT, including but not limited to:
* Presence of metal objects within the body such as a cardiac pacemaker, implanted cardiac defibrillator, brain aneurysm clips, cochlear implant, ocular foreign body, or shrapnel
* History of immediate or delayed hypersensitivity reaction or other contraindication to contrast agents including but not limited to gadolinium and iodine
* Previous enrollment in this study or another study involving the investigation of ABT-888, with the exception of receiving a single dose of study drug.
* Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-888 and/or WBRT.
18 Years
99 Years
ALL
No
Sponsors
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AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
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Principal Investigators
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Shepherd L Stacie, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 8334
Atlanta, Georgia, United States
Site Reference ID/Investigator# 52462
Chicago, Illinois, United States
Site Reference ID/Investigator# 24483
Kansas City, Kansas, United States
Site Reference ID/Investigator# 7180
Baltimore, Maryland, United States
Site Reference ID/Investigator# 19021
Detroit, Michigan, United States
Site Reference ID/Investigator# 6344
Philadelphia, Pennsylvania, United States
Site Reference ID/Investigator# 6653
Madison, Wisconsin, United States
Site Reference ID/Investigator# 18542
Toronto, , Canada
Site Reference ID/Investigator# 46322
Ponce, , Puerto Rico
Countries
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References
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Mehta MP, Wang D, Wang F, Kleinberg L, Brade A, Robins HI, Turaka A, Leahy T, Medina D, Xiong H, Mostafa NM, Dunbar M, Zhu M, Qian J, Holen K, Giranda V, Curran WJ. Veliparib in combination with whole brain radiation therapy in patients with brain metastases: results of a phase 1 study. J Neurooncol. 2015 Apr;122(2):409-17. doi: 10.1007/s11060-015-1733-1. Epub 2015 Feb 15.
Other Identifiers
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M10-128
Identifier Type: -
Identifier Source: org_study_id