At a glance
ClinicalIndex Comparison Record- ✓At least 18 years of age
- ✓Part A: Histologically or cytologically confirmed advanced solid tumor with progression on ≥1 prior chemotherapy regimen, with no standard care available or for whom PLD might be standard of care
- ✓Part B: Histologically confirmed advanced primary, locally advanced incurable, recurrent, or metastatic endometrial cancer; completed 1 line of platinum-containing chemotherapy in the advanced setting
- ✓Measurable disease by RECIST v1.1
- ✕Prior chemotherapy, radiotherapy (except brachytherapy), endocrine therapy, or investigational drugs within 4 weeks (6 weeks for nitrosoureas/Mitomycin-C) or 4 drug half-lives before first dose, whichever is longer; prior immunotherapy within 4 weeks
- ✕Part B only: Uterine carcinosarcoma, prior anthracycline therapy, or >1 prior chemotherapy regimen
- ✕Unresolved CTCAE Grade ≥2 toxicity from prior anti-cancer therapy or radiotherapy
- ✕History of spinal cord compression or brain metastases (unless asymptomatic, treated, stable, and off steroids ≥4 weeks); any history of leptomeningeal metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Phase 1, First-in-Human Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of VX-984 in Combination With Chemotherapy in Subjects With Advanced Solid Tumors
In Brief
A Phase 1 clinical trial evaluating VX-984 120 mg + PLD 40 mg/m^2, VX-984 240 mg + PLD 40 mg/m^2, and 2 other interventions for Advanced Solid Tumor. Completed, enrolled 15 participants across 5 sites.
Detailed Summary
The purpose of this study was to evaluate the safety and tolerability of VX-984 (M9831) administered alone and in combination with pegylated liposomal doxorubicin (PLD), and to determine the maximum tolerated dose (MTD) and preliminary evidence of efficacy of VX-984 in combination with PLD in participants with advanced solid tumors.
Study Details
Timeline
Interventions
Participants received VX-984 orally 120 milligram (mg) orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 120 mg in combination with pegylated liposomal doxorubicin (PLD) 40 milligram per square meter (mg/m\^2) administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m\^2.
Participants received VX-984 orally 240 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 240 mg in combination with PLD 40 mg/m\^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m\^2.
Participants received VX-984 orally 480 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 480 mg in combination with PLD 40 mg/m\^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m\^2.
Participants received VX-984 orally 720 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 720 mg in combination with PLD 40 mg/m\^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m\^2.