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To Determine the MTD and to Evaluate the Safety, Efficacy and PK Profiles of TSB-9-W1 in Pre-treated Patients With mCRC.

NCT02249650 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-04-01

No results posted yet for this study

Summary

TSB-9-W1, prepared by Taiwan Sunpan Biotechnology Co., Ltd. (TSB) is a botanical drug and applied patent in the United States (US patent No. 7,138,428 B2), Japan (Patent No.

5441947\) and Taiwan (Patent No. I432191 and I282280). The R\&D laboratory in TSB is ISO/IEC 17025 certified by Taiwan Accreditation Foundation (TAF) and the laboratory number is 2026.The trade name of TSB-9-W1 is "IDS" in English, the registration number is 01472800 at 2011 by Intellectual Property Office (IPO), Taiwan.

A phase I and pk study to determine the Maximum Tolerated Dose (MTD) and to evaluate the safety and efficacy profiles of TSB-9-W1 in pre-treated patients with metastatic colorectal cancer (mCRC).

there are 5 cohorts and a minimal 2 patients and up to 30 patients are required at phase I.

This is a single arm study. All eligible patients with mCRC will receive TSB-9-W1 treatment.

Each treatment cycle is composed by a contiguous 2-day oral administration and a contiguous 3-day rest. Patient should take the study drug once daily before meal with approximately 250 ml or appropriate amount of water.

Conditions

Interventions

DRUG

TSB-9-W1

Product name: TSB-9-W1 Unit dose: 100 mg per capsule Dosage form: Capsule Treatment cycle: A treatment cycle consists of 2-day on-dose oral administering and followed by a 3-day off-dose.

Sponsors & Collaborators

  • Virginia Contract Research Organization Co., Ltd.

    collaborator OTHER

  • Taiwan Sunpan Biotechnology Development Co., Ltd.

    lead OTHER

Principal Investigators

  • Tsai-Sheng Yang, Bachelor · Chang Gung Memorial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-10
Primary Completion
2020-02-12
Completion
2020-08-25
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT02249650 on ClinicalTrials.gov