First-in-Human Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of VX-984 in Combination With Chemotherapy

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

October 19, 2017

Study Completion Date

October 19, 2017

Conditions
Advanced Solid Tumor
Interventions
DRUG

VX-984 120 mg + PLD 40 mg/m^2

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.

DRUG

VX-984 240 mg + PLD 40 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.

DRUG

VX-984 480 mg + PLD 40 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.

DRUG

VX-984 720 mg + PLD 40 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.

Trial Locations (5)

37203

Nashville

75246

Dallas

77030

Houston

85258

Scottsdale

02215

Boston

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT02644278 - First-in-Human Study of the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of VX-984 in Combination With Chemotherapy | Biotech Hunter | Biotech Hunter