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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05580770
Registration number
NCT05580770
Ethics application status
Date submitted
22/09/2022
Date registered
14/10/2022
Titles & IDs
Public title
Mirdametinib + BGB-3245 in Advanced Solid Tumors
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Scientific title
A Phase 1/2a Open-Label, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Mirdametinib in Combination With BGB-3245 in Patients With Advanced Solid Tumors
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Secondary ID [1]
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MEKRAF-AST-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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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Mirdametinib
Treatment: Drugs - BGB-3245
Experimental: Phase 1 Dose Escalation Cohorts Ranging in Dose - Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Experimental: Phase 2 Dose Expansion A - Participants with cutaneous melanoma harboring NRAS mutations
Experimental: Phase 2 Dose Expansion B - Participants with NSCLC harboring KRAS mutations
Experimental: Phase 2 Dose Expansion C - Participants with NSCLC or cutaneous melanoma harboring BRAF Class II or Class III mutation or BRAF Fusion mutation
Treatment: Drugs: Mirdametinib
Mirdametinib administered orally
Treatment: Drugs: BGB-3245
BGB-3245 administered orally
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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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Incidence of treatment emergent adverse events
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Assessment method [1]
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Safety and tolerability endpoint evaluation via incidence of treatment emergent Adverse Events (TEAEs).
TEAEs severities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
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Timepoint [1]
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Up to 24 months
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Primary outcome [2]
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Maximum Tolerated Dose (Part 1 Only)
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Assessment method [2]
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The maximum tolerated dose (MTD) for mirdametinib and BGB-3245 administered as a combination, if any, will be based on safety and tolerability during the first 28 days of treatment in Cycle 1.
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Timepoint [2]
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Up to 18 months
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Primary outcome [3]
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Recommended Phase 2 Dose (Part 1 Only)
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Assessment method [3]
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The recommended phase 2 dose (RP2D) for mirdametinib and BGB-3245 administered as a combination will be determined based on safety, tolerability, PK, preliminary anti-tumor efficacy, and other available data.
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Timepoint [3]
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Up to 24 months
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Primary outcome [4]
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Objective Response Rate (Part 2 Only)
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Assessment method [4]
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Preliminary anti-tumor efficacy for the RP2D of mirdametinib and BGB-3245 administered as a combination as assessed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI). Objective Response Rate (ORR) defined as the proportion of participants with complete response (CR) + partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
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Timepoint [4]
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Up to 24 months
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Secondary outcome [1]
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Objective Response Rate (Part 1 Only)
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Assessment method [1]
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Preliminary anti-tumor efficacy for the RP2D of mirdametinib and BGB-3245 administered as a combination as assessed by CT or MRI. ORR defined as the proportion of participants with CR + PR using RECIST v1.1
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Timepoint [1]
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Up to 24 months
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Secondary outcome [2]
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Duration of Response Rate
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Assessment method [2]
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Duration of response rate in participants treated with the combination of mirdametinib and BGB-3245, defined as the time from response (CR + PR using RECIST v1.1) to disease progression and/or death.
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Timepoint [2]
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Up to 36 months
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Secondary outcome [3]
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Change in plasma concentrations of mirdametinib and BGB-3245
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Assessment method [3]
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To determine the PK of mirdametinib and BGB-3245 administered as a combination in the eligible participant population. Plasma concentrations of mirdametinib and BGB-3245 will be measured to evaluate systemic exposures (AUC, Cmax, Ctrough, and other PK parameters as data allow).
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Timepoint [3]
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Up to 24 months
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Eligibility
Key inclusion criteria
Key
* Able to provide informed consent
* At least 18 years of age on day of signing ICF
* Advanced, metastatic or unresectable solid cancer that has not responded to or progressed during or after at least 1 line of appropriate therapy or for which there is no treatment available or prior therapy was not tolerated.
* Part 1: oncogenic mutation or other genomic aberration of the MAPK pathway
* Part 2: oncogenic mutation or genomic aberration defined below:
* Cohort A: cutaneous melanoma harboring NRAS mutations.
* Cohort B: non-small cell lung cancer (NSCLC) harboring a KRAS mutation.
* Cohort C: NSCLC or cutaneous melanoma harboring BRAF Class II or Class III mutations or BRAF Fusion mutation.
* Must have archival tumor tissue or agree to a fresh tumor biopsy at screening
* Measurable disease per RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of = 2
* Adequate organ function and no transfusion within 14 days of first dose
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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
* Central Nervous System metastases, leptomeningeal carcinomatosis or untreated spinal cord compression
* History of glaucoma
* Active parathyroid disorder or history of malignancy associated hypercalcemia
* Clinically significant cardiac disease within the past 6 months of signing ICF
* History of toxicity from another RAF, MEK, ERK inhibitor requiring discontinuation of treatment from these agents
* Severe or uncontrolled systemic disease
* Inability to swallow oral medications
* Clinically significant active infection (HIV, Hepatitis B or Hepatitis C)
* History of or ongoing Immune Thrombocytopenia (ITP), Von Willebrand disease and/or other past or present bleeding disorders
* Underlying medical conditions in investigator's opinion to be unfavorable to be a part of the study
* Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose or anticipates need for major surgery while on study
* Systemic anti-cancer therapy within 2 weeks or 5 half-lives before first dose
* Concomitant systemic or glucocorticoid therapy within 2 weeks before first dose
* Concomitant medicines that are strong CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives before first dose
* Live vaccine within 4 weeks before first dose
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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
3/02/2023
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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
30/06/2027
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Actual
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Sample size
Target
136
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [2]
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Calvary Mater Newcastle - Waratah
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment postcode(s) [2]
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2298 - Waratah
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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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California
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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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Connecticut
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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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Florida
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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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Massachusetts
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Country [5]
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United States of America
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State/province [5]
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Ohio
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Country [6]
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United States of America
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State/province [6]
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Pennsylvania
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Country [7]
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United States of America
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State/province [7]
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
SpringWorks Therapeutics, Inc.
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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
A Phase 1/2a open-label, multicenter, dose escalation and expansion study of mirdametinib in combination with BGB-3245 in adult participants with histologically confirmed, advanced (American Joint Committee on Cancer (AJCC) Stage III or IV) metastatic or unresectable solid cancer that is refractory to or has progressed during or after at least 1 line of appropriate prior systemic anti-cancer therapy including chemotherapy, immunotherapy, or appropriate targeted therapy, or for which there is no treatment available, or prior standard of care therapy was not tolerated.
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Trial website
https://clinicaltrials.gov/study/NCT05580770
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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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Address
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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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SpringWorks Clinical
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Address
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Country
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Phone
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877-279-4870
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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
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05580770