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CDK4 Inhibitor

Dose Expansion for Breast Cancer

Phase 1

Recruiting

Research Sponsored by BeiGene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, non-small cell lung cancer, and others.

Female participants with metastatic HR+/HER2- breast cancer must be postmenopausal or receiving ovarian function suppression treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3 years

Awards & highlights

Study Summary

This trial is testing a new drug called BGB-43395 to see how well it works on its own or when combined with other drugs in participants with hormone receptor positive and human epidermal growth

Who is the study for?

This trial is for adults with advanced solid tumors, like HR+ breast cancer or non-small cell lung cancer, that rely on CDK4. Participants must have tried standard treatments without success and be in good physical condition (ECOG ≤ 1). Women with metastatic HR+/HER2- breast cancer should be postmenopausal or suppressing ovarian function.Check my eligibility

What is being tested?

The study tests BGB-43395 alone or combined with fulvestrant or letrozole in patients with certain cancers. It aims to find the best dose of BGB-43395 by gradually increasing amounts and observing effects in different groups of participants.See study design

What are the potential side effects?

Potential side effects include those common to cancer therapies targeting CDK4: fatigue, nausea, diarrhea, low blood counts leading to increased infection risk, liver issues, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have an advanced cancer that relies on CDK4, like certain breast or lung cancers.

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I am a woman with advanced HR+/HER2- breast cancer and am either postmenopausal or receiving treatment to suppress ovarian function.

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I am fully active and can carry on all pre-disease activities without restriction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395

Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395

+1 more

Secondary outcome measures

Phase 1a and 1b: Duration of Response (DOR)

Phase 1a and 1b: Time to Response (TTR)

Phase 1a: Area under the concentration-time curve (AUC) of BGB-43395 and its metabolite

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment2 Interventions

Phase 1b: The recommended dose for expansion (RFDE) for BGB-43395 (in combination with fulvestrant) from Phase 1a will be evaluated in HR+ breast cancer and selected tumor cohorts.

Group II: Dose EscalationExperimental Treatment3 Interventions

Phase 1a: Sequential cohorts of increasing dose levels of BGB-43395 will be evaluated as monotherapy and in combination with either fulvestrant or letrozole.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3690

Letrozole

2002

Completed Phase 4

~3240

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor

175 Previous Clinical Trials

28,735 Total Patients Enrolled

3 Trials studying Breast Cancer

257 Patients Enrolled for Breast Cancer

Study DirectorStudy DirectorBeiGene

1,211 Previous Clinical Trials

489,193 Total Patients Enrolled

28 Trials studying Breast Cancer

9,124 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this clinical study?

"To successfully carry out this research, a total of 79 eligible participants who meet the inclusion criteria are required. The trial will be conducted by BeiGene and managed from various locations including The University of Texas Md Anderson Cancer Center in Houston, Texas and Macquarie University Hospital in Macquarie Park, Victoria."

Answered by AI

Are there any available openings for patients to participate in this study?

"Indeed, according to clinicaltrials.gov, this investigation is actively enrolling participants. The initial posting of the study took place on December 1st, 2023, and it was last revised on January 4th, 2024."

Answered by AI

What level of risk does Dose Expansion pose to patients' safety?

"Given that this is a Phase 1 trial, there is limited data available to support the safety and effectiveness of Dose Expansion. Therefore, our team at Power rates its safety as 1 on a scale from 1 to 3."

Answered by AI

Are there various facilities within the state where this research study is currently being conducted?

"At present, this clinical trial is actively enrolling patients from a total of 4 sites. These sites are situated in Houston, Macquarie Park, Melbourne, and several other locations. It is highly recommended that participants choose the site closest to their residence in order to minimize travel requirements during their participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

2023. "BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06120283.

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