CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 52 enrolled
Drug / intervention
M3814 100 mg +6 moredrug
Likely dose
M3814 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02516813
NCT02516813Phase 1Completed
CompareCT.gov

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

EMD Serono Research & Development Institute, Inc.·interventional·Posted Aug 6, 2015·Updated Oct 15, 2024

In Brief

A Phase 1 clinical trial evaluating M3814 100 mg, M3814 200 mg, and 5 other interventions for Advanced Solid Tumors. Completed, enrolled 52 participants across 26 sites in 8 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesBelgium, Denmark, Germany, Netherlands, Norway, Sweden, Switzerland, United States
CollaboratorsMerck KGaA, Darmstadt, Germany

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 6, 2015
Enrollment StartSep 15, 2015
Primary CompletionMar 26, 2021
Study CompletionNov 19, 2021
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 10.9 years ago

Interventions

M3814 100 mgdrug

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

M3814 200 mgdrug

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

M3814 300 mgdrug

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

M3814 400 mgdrug

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

M3814 50 mgdrug

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

Fractionated RTradiation

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.

Cisplatindrug

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