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

NCT02516813 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-10-15

Study results available
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Summary

M3814 was an investigational drug that is being evaluated for the treatment of participants with locally advanced tumors. The main purposes of this study was to determine the safety, the tolerability and the efficacy of M3814 in combination with radiotherapy and in combination with chemoradiotherapy (Radiotherapy + cisplatin).

Conditions

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · Merck KGaA, Darmstadt, Germany

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-15
Primary Completion
2021-03-26
Completion
2021-11-19

Countries

  • United States
  • Belgium
  • Denmark
  • Germany
  • Netherlands
  • Norway
  • Sweden
  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02516813 on ClinicalTrials.gov