First in Human Study of M4344 in Participants With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

January 26, 2015

Primary Completion Date

June 16, 2021

Study Completion Date

September 24, 2021

Conditions
Solid TumorAdvanced Solid Tumor
Interventions
DRUG

M4344 10 mg BIW

Participants received M4344 at a dose of 10 milligrams (mg) orally twice weekly (BIW) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 20 mg BIW

Participants received M4344 at a dose of 20 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 40 mg BIW

Participants received M4344 at a dose of 40 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 80 mg BIW

Participants received M4344 at a dose of 80 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 160 mg BIW

Participants received M4344 at a dose of 160 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 300 mg BIW

Participants received M4344 at a dose of 300 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 450 mg BIW

Participants received M4344 at a dose of 450 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 700 mg BIW

Participants received M4344 at a dose of 700 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 1050 mg BIW

Participants received M4344 at a dose of 1050 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 1200 mg BIW

Participants received M4344 at a dose of 1200 mg orally BIW until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 100 mg BID

Participants received M4344 at a dose of 100 mg orally twice daily (BID) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 150 mg QD

Participants received M4344 at a dose of 150 mg orally once daily (QD) until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 250 mg QD

Participants received M4344 at a dose of 250 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 350 mg QD

Participants received M4344 at a dose of 350 mg orally QD until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 400 mg

Participants received M4344 at a dose of 400 mg orally on Day 2 and Day 9 until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

M4344 500 mg

Participants received M4344 at a dose of 500 mg orally on Day 2 and Day 9 until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

DRUG

Carboplatin

Participants received intravenous infusion of Carboplatin at a dose of Area Under Curve5 (AUC5) on Day 1 of 21-day cycle until disease progression, death, unacceptable toxicity, new anticancer treatment was started, or study withdrawal.

Trial Locations (16)

8903

Rutgers Cancer Institute of New Jersey, New Brunswick

10065

Memorial Sloan-Kettering Cancer Center (MSKCC), New York

37203

Tennessee Oncology, Nashville

37232

Vanderbilt University Medical Center, Nashville

53226

Froedtert & The Medical College of Wisconsin, Wauwatosa

63110

Washington University in St. Louis, St Louis

02114

Massachusetts General Hospital, Boston

48109-5901

University of Michigan Comprehensive Cancer Center, Ann Arbor

3075 EA

Erasmus Medisch Centrum, Rotterdam

Unknown

Hospital Clinic de Barcelona, Barcelona

Hospital Universitari Vall d'Hebron, Barcelona

"Fundacion Jimenez Diaz START Madrid. Oncology Phase I", Madrid

START Madrid. Fundacion Jimenez Diaz- Oncologia-Fase I, Madrid

"Hospital Clinico Universitario de Valencia Servicio de Hematologia y Oncologia Medica", Valencia

Royal Marsden Hospital, Sutton

W1G 6AD

Sarah Cannon Research Institute UK, London

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT02278250 - First in Human Study of M4344 in Participants With Advanced Solid Tumors | Biotech Hunter | Biotech Hunter