NCT03225105

M3541 in Combination With Radiotherapy in Solid Tumors

A Phase I, Open-label, Uncontrolled, Multicenter, Dose-escalation Study of M3541 in Combination With Palliative Radiotherapy in Subjects With Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This dose-escalation study evaluated the safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and explore antitumor activity of M3541 in combination with fractionated palliative radiotherapy (RT) in participants with solid tumors with malignant lesions in the thorax, abdominal cavity, head and neck region, or extremities likely to benefit from palliative RT.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	M3541	Participants received M3541 orally once per fraction day (FD) for two consecutive calendar weeks (that is, Monday through Friday, with Saturday and Sunday as M3541 holidays).
RADIATION	Palliative Radiotherapy (RT)	Participants received RT dose of 30 Gray (Gy) given in 10 fractions (3 Gy given per fraction day) administered over two consecutive calendar weeks (that is, Monday through Friday, with Saturday and Sunday as RT holidays).

Timeline

• Start date: 2017-09-06
• Primary completion: 2019-09-02
• Completion: 2020-04-27
• First posted: 2017-07-21
• Last updated: 2023-11-22
• Results posted: 2023-11-22

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study