A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Solid Tumors
NCT ID: NCT05071183
Last Updated: 2024-04-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
9 participants
INTERVENTIONAL
2021-09-23
2023-03-01
Brief Summary
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Detailed Description
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Phase 2 Efficacy Evaluation: Investigate the anti-tumor efficacy and safety of repotrectinib in combination with other anticancer therapies for the treatment of patients with locally advanced or metastatic KRAS-mutant solid tumors.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TPX-0005 + Trametinib
TPX-0005 + Trametinib Dose Escalation and Dose Expansion
Dose escalation: KRAS G12D mutant advanced solid tumors. Dose expansion: KRAS G12D locally advanced or metastatic NSCLC
TPX-0005
Oral TPX-0005 capsules
Trametinib
Oral trametinib tablets
Interventions
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TPX-0005
Oral TPX-0005 capsules
Trametinib
Oral trametinib tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological or cytological confirmation of unresectable or metastatic solid tumor malignancy harboring a KRAS mutation.
* No more than 3 prior standard treatments appropriate for tumor type and stage of disease.
* ECOG performance status ≤ 1.
* Existence of measurable disease (according to Response evaluation criteria in solid tumors \[RECIST v1.1\] criteria).
* Subjects with asymptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible.
* Adequate organ function.
Exclusion Criteria
* Previous other cancer requiring treatment within the previous two years.
* Clinically significant cardiovascular disease.
* Any of the following cardiac criteria:
* Mean resting corrected QT interval (QTc) \> 470 msec obtained from three ECGs and any factors that increase the risk of QTc prolongation or arrhythmic events
* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
* Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
* Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.
* Subjects being treated with or anticipating the need for treatment with strong CYP3A inhibitors or inducers.
18 Years
ALL
No
Sponsors
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Turning Point Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 2101
California City, California, United States
Local Institution - 2109
California City, California, United States
Local Institution - 2106
Denver, Colorado, United States
Local Institution - 2108
Nashville, Tennessee, United States
Local Institution - 2107
Houston, Texas, United States
Local Institution - 2102
Virginia Beach, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA127-1025
Identifier Type: OTHER
Identifier Source: secondary_id
TPX-0005-13
Identifier Type: OTHER
Identifier Source: secondary_id
CA127-1025
Identifier Type: -
Identifier Source: org_study_id
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