Advanced Solid Tumor Clinical Trial
Official title:
A Phase 1b/2 Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant Advanced Solid Tumors (TRIDENT-2)
Verified date | March 2024 |
Source | Turning Point Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A Phase 1b/2 Study of Repotrectinib in Combination with Other Anticancer Therapies for the Treatment of Subjects with KRAS-Mutant Advanced Solid Tumors (TRIDENT-2)
Status | Terminated |
Enrollment | 9 |
Est. completion date | March 1, 2023 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 (or as required by local regulation). - 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: - Major surgery within four weeks of the start of treatment. - 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. |
Country | Name | City | State |
---|---|---|---|
United States | 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 - 2107 | Houston | Texas |
United States | Local Institution - 2108 | Nashville | Tennessee |
United States | Local Institution - 2102 | Virginia Beach | Virginia |
Lead Sponsor | Collaborator |
---|---|
Turning Point Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Dose Limiting Toxicities | Number of participants with first cycle DLTs to determine Mean Tolderable Dose (MTD) and/or RP2D.
A DLT is defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications that meets the criteria defined in each subprotocol. The MTD is defined as the highest dose level of repotrectinib given in combination with other anticancer therapy observed to cause a DLT in fewer than 33% of the treated subjects in the first treatment cycle (i.e., Cycle 1). |
From initial dose to end of first cycle of treatment, approximately 28 days | |
Secondary | Overall Response Rate (ORR) Assessed the Investigator Using RECIST v1.1. | The ORR will be defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR). A confirmed response is a response that persists on a repeat imaging performed at least 4 weeks after initial documentation of response. Participants with a confirmed objective response (CR or PR) will be referred to as responders.
Radiographic confirmation of objective tumor response (CR or PR) or disease progression will be based on RECIST v1.1. The ORR will be reported as the percentage of responders by RECIST v1.1 along with the corresponding two-sided 95% Clopper-Pearson exact CI. Complete Response (CR) = Disappearance of all target lesions Partial Response (PR) = >=30% decrease in the sum diameters of target lesions. |
From screening to end of treatment approximately 10 months | |
Secondary | Cmax of Repotrectinib | Cmax is defined as maximum plasma concentration of the drug. | At Cycle 1 Day 1 and Cycle 1 Day 22 | |
Secondary | Tmax of Repotrecitinib | Tmax is defined is the time to maximum plasma concentration | At Cycle 1 Day 1 and Cycle 1 Day 22 | |
Secondary | AUC 0-24 of Repotrecitinib | Area under the plasma concentration time-curve. AUC from time 0 to 24 hours after dose. | At Cycle 1 Day 1 and Cycle 1 Day 22 | |
Secondary | Cmax of Trametinib | Cmax is defined as maximum plasma concentration of the drug. | At Cycle 1 Day 1 and Cycle 1 Day 22 | |
Secondary | Tmax of Trametinib | Tmax is defined is the time to maximum plasma concentration | At Cycle 1 Day 1 and Cycle 1 Day 22 | |
Secondary | AUC 0-24 of Trametinib | Area under the plasma concentration time-curve. AUC from time 0 to 24 hours after dose. | At Cycle 1 Day 1 and Cycle 1 Day 22 |
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