NCT02516813

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

An Open Label, Phase Ia/Ib Trial of the DNA-PK Inhibitor MSC2490484A in Combination With Radiotherapy in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Advanced Solid Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-09-15
• Primary completion: 2021-03-26
• Completion: 2021-11-19
• First posted: 2015-08-06
• Last updated: 2024-10-15
• Results posted: 2024-10-15

Locations

26 sites across 8 countries: United States, Belgium, Denmark, Germany, Netherlands, Norway, Sweden, Switzerland