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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06120283
Registration number
NCT06120283
Ethics application status
Date submitted
1/11/2023
Date registered
7/11/2023
Date last updated
24/04/2024
Titles & IDs
Public title
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
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Scientific title
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
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Secondary ID [1]
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2023-506888-34-00
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Secondary ID [2]
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BGB-43395-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor
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Advanced Breast Cancer
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Metastatic Breast Cancer
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Hormone-receptor-positive Breast Cancer
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Hormone Receptor Positive Breast Carcinoma
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Hormone Receptor Positive Malignant Neoplasm of Breast
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HER2-negative Breast Cancer
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Hormone Receptor Positive HER-2 Negative Breast Cancer
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Non-small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Breast
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Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BGB-43395
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Letrozole
Experimental: Dose Escalation - Phase 1a: Sequential cohorts of increasing dose levels of BGB-43395 will be evaluated as monotherapy and in combination with either fulvestrant or letrozole.
Experimental: Dose Expansion - 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.
Treatment: Drugs: BGB-43395
Planned doses administered orally.
Treatment: Drugs: Fulvestrant
Standard dose administered via intramuscular injection.
Treatment: Drugs: Letrozole
Standard dose administered orally as a tablet.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [1]
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Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
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Timepoint [1]
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Up to approximately 3 years
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Primary outcome [2]
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Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-43395
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Assessment method [2]
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MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate of 28%. MAD is defined as the highest dose administered if MTD is not reached.
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Timepoint [2]
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Up to approximately 3 years
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Primary outcome [3]
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Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-43395
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Assessment method [3]
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RDFE of BGB-43395 alone or in combination with fulvestrant or letrozole will be determined based upon the MTD or MAD.
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Timepoint [3]
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Up to approximately 3 years
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Primary outcome [4]
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Phase 1b: Objective Response Rate (ORR)
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Assessment method [4]
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ORR is defined as the percentage of participants who have confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
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Timepoint [4]
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Up to approximately 3 years
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Secondary outcome [1]
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Phase 1a: ORR
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Assessment method [1]
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ORR is defined as the percentage of participants who have confirmed CR or PR assessed by the investigator using RECIST v1.1.
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Timepoint [1]
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Up to approximately 3 years
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Secondary outcome [2]
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Phase 1a and 1b: Duration of Response (DOR)
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Assessment method [2]
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DOR is defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.
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Timepoint [2]
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Up to approximately 3 years
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Secondary outcome [3]
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Phase 1a and 1b: Time to Response (TTR)
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Assessment method [3]
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TTR is defined as the time from the date of the first dose of study drugs to the date of the first determination of objective response by the investigator using RECIST v1.1.
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Timepoint [3]
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Up to approximately 3 years
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Secondary outcome [4]
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Phase 1b: Disease Control Rate (DCR)
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Assessment method [4]
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DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease assessed by the investigator using RECIST v1.1.
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Timepoint [4]
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Up to approximately 3 years
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Secondary outcome [5]
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Phase 1b: Clinical Benefit Rate (CBR)
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Assessment method [5]
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CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting = 24 weeks.
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Timepoint [5]
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Up to approximately 3 years
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Secondary outcome [6]
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Phase 1b: Progression-Free Survival (PFS)
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Assessment method [6]
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PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
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Timepoint [6]
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Up to approximately 3 years
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Secondary outcome [7]
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Phase 1b: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
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Assessment method [7]
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Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), and laboratory assessments.
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Timepoint [7]
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Up to approximately 3 years
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Secondary outcome [8]
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Phase 1a: Observed Plasma Maximum Concentration (Cmax) of BGB-43395 and its metabolite
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Assessment method [8]
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Timepoint [8]
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From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
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Secondary outcome [9]
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Phase 1a: Observed Plasma Trough Concentration (Ctrough) of BGB-43395 and its metabolite
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Assessment method [9]
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Timepoint [9]
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From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
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Secondary outcome [10]
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Phase 1a: Area under the concentration-time curve (AUC) of BGB-43395 and its metabolite
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Assessment method [10]
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Timepoint [10]
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From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
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Secondary outcome [11]
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Phase 1a: Half-life (t1/2) of BGB-43395 and its metabolite
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Assessment method [11]
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Timepoint [11]
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From Cycle 1 Day 1 up to Cycle 7 Day 1 (each cycle is 28 days)
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Secondary outcome [12]
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Phase 1b: Plasma concentrations of BGB-43395 and its metabolite
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Assessment method [12]
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Timepoint [12]
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From Cycle 1 Day 1 up to Cycle 5 Day 1 (each cycle is 28 days)
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Eligibility
Key inclusion criteria
- 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.
- Phase 1a: Received prior therapy for their condition (if available) and should be
refractory to or intolerant of standard-of-care therapies. In regions where approved
and available, participants with HR+ breast cancer must have received at least 2 prior
lines of treatment.
- Phase 1b (Dose Expansion): Selected tumor cohorts will include HR+/HER2- breast cancer
and additional tumor types.
- Phase 1b: Participants with HR+/HER2- breast cancer enrolled in regions where CDK4/6
inhibitors are approved and available must have received at least one line of therapy
for advanced disease including endocrine therapy and a CDK4/6 inhibitor. Participants
can have received up to 2 lines of prior cytotoxic chemotherapy for advanced disease.
- Eastern Cooperative Oncology Group (ECOG) Performance Status = 1.
- Female participants with metastatic HR+/HER2- breast cancer must be postmenopausal or
receiving ovarian function suppression treatment.
- Adequate organ function without symptomatic visceral disease.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior therapy selectively targeting CDK4 (prior CDK4/6 inhibitor therapy is permitted
and required in local regions where it is approved and available).
- Known leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Any malignancy = 3 years before the first dose of study drug(s) except for the
specific cancer under investigation in this study and any locally recurring cancer
that has been treated with curative intent (eg, resected basal or squamous cell skin
cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
- Uncontrolled diabetes.
- Infection requiring systemic antibacterial, antifungal, or antiviral therapy = 28 days
before the first dose of study drug(s), or symptomatic COVID-19 infection.
- History of hepatitis B or active hepatitis C infection.
- Prior allogeneic stem cell transplantation, or organ transplantation.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/05/2026
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Actual
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Sample size
Target
79
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Blacktown Cancer and Haematology Centre - Blacktown
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Recruitment hospital [2]
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Macquarie University - North Ryde
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Recruitment hospital [3]
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Austin Health - Heidelberg
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Recruitment hospital [4]
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Peter Maccallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2109 - North Ryde
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Recruitment postcode(s) [3]
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3084 - Heidelberg
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Colorado
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Country [2]
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United States of America
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State/province [2]
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North Carolina
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Country [3]
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United States of America
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State/province [3]
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Ohio
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Country [4]
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United States of America
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State/province [4]
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
BeiGene
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a dose escalation and dose expansion study to compare how well BGB-43395, a
cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with
either fulvestrant or letrozole in participants with hormone receptor positive (HR+) and
human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid
tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06120283
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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BeiGene
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Director
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Address
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Country
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Phone
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1.877.828.5568
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06120283
Download to PDF