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AzTrials

Breast CancerPhase 1NCT04274933

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

A Phase 1 study testing Venetoclax and Capecitabine in people with Breast Cancer and Cancer, run by AbbVie at 18 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Endocrine therapy is the initial treatment for most hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancers. This study will evaluate the use of venetoclax in combination with capecitabine in adult participants with HR+, HER2-, metastatic breast cancer (MBC) who had… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Cancer
What is being tested?
Venetoclax and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
18 sitesin 4 countries
Study dates
21 May 2020to 8 Oct 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of advanced or metastatic breast cancer that is hormone receptor positive (HR+) and HER2 negative (HER2-).
  • 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.

Who cannot join

  • History of receiving systemic cytotoxic chemotherapy in the locally advanced or metastatic setting.
  • 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.

Trial locations and contacts

18 sites in 4 countries.

18 sites in 4 countries

United States11 sites

  • Massachusetts General Hospital /ID# 214833

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute /ID# 214832

    Boston, Massachusetts, 02215

  • Greenville Health System Cance /ID# 216059

    Greenville, South Carolina, 29605

  • MD Anderson Cancer Center /ID# 214867

    Houston, Texas, 77030

  • Joliet Oncology-Hematology Associates, LTD /ID# 215051

    Joliet, Illinois, 60435

  • Masonic Cancer Center /ID# 216101

    Minneapolis, Minnesota, 55455

  • Vanderbilt University Med Ctr /ID# 213852

    Nashville, Tennessee, 37232-6307

  • Memorial Sloan Kettering Cancer Center /ID# 214886

    New York, New York, 10065-6007

  • University of Pennsylvania /ID# 216357

    Philadelphia, Pennsylvania, 19104-5502

  • Utah Cancer Specialists /ID# 215375

    Salt Lake City, Utah, 84106

  • Swedish Cancer Institute /ID# 216120

    Seattle, Washington, 98104

Other trials in United States

Germany4 sites

  • Charite Universitaetsmedizin Berlin /ID# 215287

    Berlin, 10117

  • Universitaetsklinik Heidelberg /ID# 214679

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitatsklinikum Tubingen /ID# 217021

    Tübingen, 72076

  • Universitaetsklinikum Ulm /ID# 214678

    Ulm, Thuringia, 89081

Other trials in Germany

Puerto Rico2 sites

  • Pan American Center for Oncology Trials, LLC /ID# 216862

    Rio Piedras, 00935

  • GCM Medical Group PSC - Hato Rey /ID# 216904

    San Juan, 00917-3104

Other trials in Puerto Rico

Japan1 site

  • Aichi Cancer Center Hospital /ID# 224527

    Nagoya, Aichi-ken, 464-8681

Other trials in Japan

About this study

Official title: A Phase 1b Study of Venetoclax and Capecitabine In Subjects With Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Experienced Disease Progression During or After CDK4/6 Inhibitor Therapy

Endocrine therapy is the initial treatment for most hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancers. This study will evaluate the use of venetoclax in combination with capecitabine in adult participants with HR+, HER2-, metastatic breast cancer (MBC) who had disease progression following treatment that included a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.

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.

Read more

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.

Keywords
Breast Cancer, Metastatic, Locally Advanced, Venetoclax, Capecitabine, Hormone Receptor Positive, HER2 Negative
Medical subject headings
Breast Neoplasms, Neoplasms, Neoplasm Metastasis

What participants receive

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

Study groups in NCT04274933
Study groupRoleWhat they receive
Dose Escalation: Venetoclax and CapecitabineExperimentalVenetoclax at various doses will be administered in combination with capecitabine until a recommended dose is determined.
Receives: Drug: Venetoclax; Drug: Capecitabine
Dose Expansion: Venetoclax and CapecitabineExperimentalVenetoclax at the dose identified in Dose Escalation administered in combination with capecitabine.
Receives: Drug: Venetoclax; Drug: Capecitabine

What is being measured

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

  1. Number of participants with Dose Limiting Toxicities (DLTs)

    Adverse events that are considered by the investigator to have a reasonable possibility of relationship to the administration of venetoclax in combination with capecitabine will be considered a DLT.

    Measured: Up to 21 days after first dose of study drug

  2. Maximum observed plasma concentration (Cmax) of venetoclax

    Maximum observed plasma concentration (Cmax) of venetoclax

    Measured: Up to 9 days after first dose of study drug

  3. Maximum observed plasma concentration (Cmax) of capecitabine

    Maximum observed plasma concentration (Cmax) of capecitabine.

    Measured: Up to 9 days after first dose of study drug

  4. Maximum observed plasma concentration (Cmax) of 5-fluorouracil

    Maximum observed plasma concentration (Cmax) of 5-fluorouracil.

    Measured: Up to 9 days after first dose of study drug

  5. Time to Cmax (peak time, Tmax) of venetoclax

    Time to Cmax (peak time, Tmax) of venetoclax.

    Measured: Up to 9 days after first dose of study drug

  6. Time to Cmax (peak time, Tmax) of 5-fluorouracil

    Time to Cmax (peak time, Tmax) of 5-fluorouracil.

    Measured: Up to 9 days after first dose of study drug

  7. Time to Cmax (peak time, Tmax) of capecitabine

    Time to Cmax (peak time, Tmax) of capecitabine.

    Measured: Up to 9 days after first dose of study drug

  8. Area under the plasma concentration versus time curve (AUC) for venetoclax up to 24 hours post-dose (AUC0-24)

    Area under the plasma concentration versus time curve for venetoclax up to 24 hours post-dose.

    Measured: Up to 24 hours

  9. Area under the plasma concentration versus time curve (AUC) for capecitabine/5-fluorouracil up to 12 hours post-dose (AUC0-12)

    Area under the plasma concentration versus time curve for capecitabine/5-fluorouracil up to 12 hours post-dose.

    Measured: Up to 12 hours

Timeline

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

  1. First posted18 Feb 2020
  2. Study start21 May 2020
  3. Primary completion8 Oct 2020
  4. Study completion8 Oct 2020

Why it stopped: Company Decision

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
Sequential
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04274933
Sponsor's protocol ID
M19-992
Other IDs
2019-003452-36, 2019
Status last verified
Oct 2020
First submitted
17 Feb 2020
Last updated
29 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Venetoclax and Capecitabine in people with Breast Cancer and Cancer, run by AbbVie at 18 sites in 4 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Germany, Puerto Rico, Japan. 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 was stopped early (reason given: Company Decision). Results are not available in the source record.

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?

Number of participants with Dose Limiting Toxicities (DLTs) (time frame: Up to 21 days after first dose of study drug). The study lists 9 primary outcomes in all. 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 NCT04274933.

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 29 Oct 2020.

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