An Open-Label Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M4344 (Formerly VX-803) as a Single Agent and in Combination With Cytotoxic Chemotherapy in Participants With Advanced Solid Tumors
Abstract
The purpose of this study was to evaluate the safety and tolerability of multiple ascending doses of single-agent M4344 administered twice-weekly (BIW), twice daily (BID) or once daily dose schedule in participants with advanced solid tumors. This investigation is a three part study examining M4344 alone and in combination with carboplatin to determine the safety and maximum tolerated dose.
Conditions: Solid Tumor, Advanced Solid Tumor.
Primary outcome: Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); Part A: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0); Part A: Number of Participants With Clinically Relevant Findings in Vital Signs; Part A: Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs); Part A: Maximum Tolerated Dose (MTD) of M4344 Administered Twice Weekly (BIW); Part A2: Number of Participants With Treatment-Emergent Adverse Events (TEAEs); Part A2: Number of Participants With Grade 3 or 4 (Greater Than [>] 20 Percent [%] of Total) in Laboratory Parameters Based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0); Part A2: Number of Participants With Clinically Relevant Findings in Vital Signs; Part A2: Number of Participants With Clinically Significant…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 97 participants or records.
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