NCT02516813 - Phase 1 Trial of MSC2490484A, an Inhibitor of a DNA-dependent Protein Kinase, in Combination With Radiotherapy | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 15, 2015

Primary Completion Date

March 26, 2021

Study Completion Date

November 19, 2021

Conditions

Advanced Solid Tumors

Interventions

DRUG

M3814 100 mg

Participants received 100 mg of M3814 as capsule or tablet orally once daily.

DRUG

M3814 200 mg

Participants received 200 mg of M3814 as capsule or tablet orally once daily.

DRUG

M3814 300 mg

Participants received 300 mg of M3814 as capsule or tablet orally once daily.

DRUG

M3814 400 mg

Participants received 400 mg of M3814 as capsule or tablet orally once daily.

DRUG

M3814 50 mg

Participants received 100 mg of M3814 as capsule orally once daily.

RADIATION

Fractionated RT

Participants received fractionated palliative RT (3 Gray \[Gy\] \* 10 in Arm A and 2 Gy \* 33 to 35, 5 fractions per week \[F/W\]) in Arm B and received a single high dose of RT (10-25 Gy) capsule on Day 1 given on Lesion 1 and a single high dose of RT (10-25 Gy) on Day 2 given on Lesion 2 in ancillary CPoP part.

DRUG

Cisplatin

Participants received Cisplatin twice at a dose of 100 mg/m\^2 or weekly at a dose of 40 mg/m\^2.

Trial Locations (26)

10065

Memorial Sloan Kettering Cancer Center, New York

10461

Montefiore Medical Center PRIME, The Bronx

19107

Thomas Jefferson University Hospital, Philadelphia

33136

University of Miami Miller School of Medicine, Miami

33308

Holy Cross Hospital Inc., Fort Lauderdale

59101

Research site, Billings

77030

Research site, Houston

79106

Research site, Freiburg im Breisgau

93720

Research site, Fresno

98405

Research site, Tacoma

Unknown

Research site, Leuven

Rigshospitalet - PARENT, Copenhagen

Herlev Hospital - PARENT, Herlev

Charite Research Organisation GmbH - Phase - I Unit of Hematology and Oncology, Berlin

Universitaetsklinikum Carl Gustav Carus TU Dresden, Dresden

Universitaetsklinikum Essen - Westdeutsches Tumorzentrum, Essen

Universitaetsklinikum Heidelberg - RadioOnkologie und Strahlentherapie, Heidelberg

Universitaetsklinikum Schleswig-Holstein - Campus Kiel - Klinik für diagnostische Radiologie, Kiel

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - Klinik und Poliklinik fuer Radiologie, Mainz

Klinikum Mannheim GmbH Universitaetsklinikum - Parent, Mannheim

Universitaetsklinikum Tuebingen - Medizinische Klinik I, Tübingen

Antoni van Leeuwenhoek Ziekenhuis, Amsterdam

Research site, Oslo

Karolinska universitetssjukhuset - Solna - Radiumhemmet (onkologi), Solna

Universitaetsspital Zuerich - Parent, Zurich

1066 CX

Research site, Amsterdam

All Listed Sponsors

collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY