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Phase 2a Study to Evaluate Suppression of 5-Fluorouracil -Induced Mucositis by TK112690

NCT05669521 · 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 500 mg/m2 of Leucovorin by iv \& 500 mg/m2 of Fluorouracil (5FU) by iv bolus for their Colorectal Cancer. The patients will receive a one-hour infusion of TK-90 or equivalent TK-90 placebo depending on randomization at 5 hours \& 11 hours post 5-FU iv bolus. This treatment cycle will continue weekly for 6 weeks. The TK112690 dose will be 45 mg/kg.

Conditions

Interventions

DRUG

TK-112690

TK112690 treatment Post 5-FU chemotherapy

DRUG

Placebo

Placebo treatment Post 5-FU chemotherapy

Sponsors & Collaborators

  • SIRO Clinpharm Pvt. Ltd.

    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
2022-06-15
Primary Completion
2023-09-30
Completion
2023-09-30
FDA Drug
Yes

Countries

  • India

Study Locations

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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 NCT05669521 on ClinicalTrials.gov