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Phase 2a Study to Evaluate Suppression of Radiotherapy-induced Mucositis by TK112690

NCT05658016 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-08-14

No results posted yet for this study

Summary

Patients expected to receive a continuous course of radiation as single daily fractions of 2.0 Gy treatment with a cumulative radiation dose of 70 Gy. The radiation can be 2DRT, 3DRT,IMRT etc. Prior to each radiation treatment the patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization. 6 Hours after the completion of TK-90 infusion or TK-90 placebo dose, the patients will receive another identical TK-90 or TK-90 placebo treatment depending on randomization. This treatment cycle will continue for 7 weeks. The TK112690 dose will be 45 mg/kg.

Conditions

Interventions

DRUG

TK-112690

TK112690 treatment Pre \& Post Radiation

DRUG

Placebo

TK112690 Placebo treatment Pre \& Post Radiation

Sponsors & Collaborators

  • SIRO Clinpharm Private Limited

    collaborator UNKNOWN

  • Tosk, Inc.

    lead INDUSTRY

Principal Investigators

  • Emile Youssef, MD, PhD · Tosk, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-17
Primary Completion
2023-09-30
Completion
2023-09-30
FDA Drug
Yes

Countries

  • India

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 NCT05658016 on ClinicalTrials.gov