A Study to Evaluate the Safety and Tolerability of Venetoclax Tablets in Combination With Capecitabine Tablets in Adult Participants With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Had Disease Progression During or After CDK4/6 Inhibitor Therapy
NCT ID: NCT04274933
Last Updated: 2020-10-29
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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TERMINATED
PHASE1
4 participants
INTERVENTIONAL
2020-05-21
2020-10-08
Brief Summary
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Venetoclax is an investigational drug being developed for the treatment of breast cancer. This study is open-label meaning both the participants and study doctors will know what treatment is being given. The study includes two phases: dose escalation and dose expansion. In dose escalation, participants will receive various doses of venetoclax in combination with capecitabine. In dose expansion, participants will receive the recommended dose of venetoclax determined during dose escalation in combination with capecitabine. Adult participants with locally advanced or MBC that is not amenable to curative therapy will be enrolled. Around 42 participants will be enrolled at approximately 20 sites worldwide.
Venetoclax and capecitabine will be administered on a 21-day cycle. During dose escalation, participants will take various doses of venetoclax as a tablet by mouth once a day and capecitabine as a tablet by mouth twice per day on days 1 - 14 of each cycle for approximately 30 weeks. During dose expansion, participants will take venetoclax at the dose identified during dose escalation as a tablet by mouth once a day and capecitabine as a tablet by mouth twice per day on days 1 - 14 of each cycle for approximately 30 weeks.
There may be a higher burden for participants in this trial compared to standard of care. Participants will attend weekly visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and evaluating for side effects.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation: Venetoclax and Capecitabine
Venetoclax at various doses will be administered in combination with capecitabine until a recommended dose is determined.
Venetoclax
Tablet; Oral
Capecitabine
Tablet; Oral
Dose Expansion: Venetoclax and Capecitabine
Venetoclax at the dose identified in Dose Escalation administered in combination with capecitabine.
Venetoclax
Tablet; Oral
Capecitabine
Tablet; Oral
Interventions
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Venetoclax
Tablet; Oral
Capecitabine
Tablet; Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance score of 0-1.
* Willing to provide tissue biopsy sample prior to start of study treatment, and in participants with measurable disease, at Day 1 of Cycle 3.
* Escalation cohort: Able to provide a tissue sample obtained at any time in disease history prior to start of study treatment.
* Expansion cohort: Able to provide a fresh tissue sample from either primary tumor or metastatic site; if fresh sample collection is deemed unsafe by the investigator, then an archival tissue block is acceptable if obtained at time of most recent progression and within 16 weeks of study treatment.
* Experienced disease progression during or after CDK4/6 inhibitor therapy administered in combination with endocrine therapy for a minimum of 8 weeks prior to progression.
Exclusion Criteria
* Received anti-cancer therapy within the previous 21 days prior to the start of study drugs.
* No known uncontrolled metastases to the central nervous system (CNS). Participants with brain metastases are eligible provided they have shown positive clinical and radiographic stable disease for at least 4 weeks after definitive therapy and have not used steroids for at least 2 weeks prior to first dose of study drugs.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Joliet Oncology-Hematology Associates, LTD /ID# 215051
Joliet, Illinois, United States
Massachusetts General Hospital /ID# 214833
Boston, Massachusetts, United States
Dana-Farber Cancer Institute /ID# 214832
Boston, Massachusetts, United States
Masonic Cancer Center /ID# 216101
Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Center /ID# 214886
New York, New York, United States
University of Pennsylvania /ID# 216357
Philadelphia, Pennsylvania, United States
Greenville Health System Cance /ID# 216059
Greenville, South Carolina, United States
Vanderbilt University Med Ctr /ID# 213852
Nashville, Tennessee, United States
MD Anderson Cancer Center /ID# 214867
Houston, Texas, United States
Utah Cancer Specialists /ID# 215375
Salt Lake City, Utah, United States
Swedish Cancer Institute /ID# 216120
Seattle, Washington, United States
Universitaetsklinik Heidelberg /ID# 214679
Heidelberg, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm /ID# 214678
Ulm, Thuringia, Germany
Charite Universitaetsmedizin Berlin /ID# 215287
Berlin, , Germany
Universitatsklinikum Tubingen /ID# 217021
Tübingen, , Germany
Aichi Cancer Center Hospital /ID# 224527
Nagoya, Aichi-ken, Japan
Pan American Center for Oncology Trials, LLC /ID# 216862
Rio Piedras, , Puerto Rico
GCM Medical Group PSC - Hato Rey /ID# 216904
San Juan, , Puerto Rico
Countries
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Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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2019-003452-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M19-992
Identifier Type: -
Identifier Source: org_study_id