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Brain DiseasesPhase 1NCT00649207

A Phase I Study of ABT-888 in Combination With Conventional Whole Brain Radiation Therapy (WBRT) in Cancer Patients With Brain Metastases

A Phase 1 study testing ABT-888 and Whole Brain Radiation Therapy in people with Brain Diseases and Brain Neoplasms, run by AbbVie (prior sponsor, Abbott) at 9 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Whole Brain Radiation Therapy (WBRT) in treating patients with brain metastases. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
ABT-888 and Whole Brain Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
9 sitesin 3 countries
Study dates
Mar 2008to Mar 2013
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age is greater than or equal to 18 years.
  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • Brain metastases secondary to germ cell tumor or lymphoma malignancy.
  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

9 sites in 3 countries.

9 sites in 3 countries

United States7 sites

  • Site Reference ID/Investigator# 8334

    Atlanta, Georgia, 30322

  • Site Reference ID/Investigator# 7180

    Baltimore, Maryland, 21231-2410

  • Site Reference ID/Investigator# 52462

    Chicago, Illinois, 60611

  • Site Reference ID/Investigator# 19021

    Detroit, Michigan, 48202-2689

  • Site Reference ID/Investigator# 24483

    Kansas City, Kansas, 66160

  • Site Reference ID/Investigator# 6653

    Madison, Wisconsin, 53792

  • Site Reference ID/Investigator# 6344

    Philadelphia, Pennsylvania, 19111

Other trials in United States

Canada1 site

  • Site Reference ID/Investigator# 18542

    Toronto, M5G 2M9

Other trials in Canada

Puerto Rico1 site

  • Site Reference ID/Investigator# 46322

    Ponce, 00716

Other trials in Puerto Rico

About this study

Official title: A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of ABT-888 in Combination With Whole Brain Radiation Therapy in Subjects With Brain Metastases

This Phase I clinical trial is studying the side effects and best dose of ABT-888 when given together with Whole Brain Radiation Therapy (WBRT) in treating patients with brain metastases.

Read the detailed description

This is a Phase 1, multicenter, dose-escalation study evaluating the safety, tolerability and pharmacokinetics of the PARP inhibitor ABT-888 in combination with conventional whole brain radiation therapy (WBRT) in the treatment of subjects with solid tumors metastatic to the brain.

Being tested
ABT-888, Whole Brain Radiation Therapy
Keywords
WBRT, Brain Metastases, Radiation, ABT-888, PARP
Medical subject headings
Brain Diseases, Brain Neoplasms, Central Nervous System Diseases, Neoplasm Metastasis, Nervous System Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABT-888Drug

    Also called veliparib

    Oral Capsules

  • Whole Brain Radiation TherapyRadiation

    Also called WBRT

    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

Study groups in NCT00649207
Study groupRoleWhat they receive
1ExperimentalThis 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).
Receives: Drug: ABT-888; Radiation: Whole Brain Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determine the maximum tolerated dose of ABT-888 in combination with whole brain radiation therapy

    Measured: ABT-888 will be dose escalated until the largest dose is reached that is felt to be safe based on safety information from all subjects.

Secondary outcomes (3)

  1. Safety Assessment Physical and Neurological Exam

    Measured: be performed at all study visits, final and follow-up visit

  2. Safety Assessment Mini-Mental State Examination

    Measured: be performed at all study visits, final and follow-up visit

  3. Safety Assessment Laboratory testing

    Chemistry and Hematology labs will be collected

    Measured: be performed at all study visits, final and follow-up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00649207
Sponsor's protocol ID
M10-128
Status last verified
May 2013
First submitted
28 Mar 2008
Last updated
21 Nov 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25682091

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABT-888 and Whole Brain Radiation Therapy in people with Brain Diseases and Brain Neoplasms, run by AbbVie (prior sponsor, Abbott) at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the maximum tolerated dose of ABT-888 in combination with whole brain radiation therapy (time frame: ABT-888 will be dose escalated until the largest dose is reached that is felt to be safe based on safety information from all subjects.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00649207, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2017.

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