TS-1 in Combination With Calcium Folinate in Patients With Heavily Pre-treated mCRC

May 4, 2018 updated by: TTY Biopharm

A Phase II Study Assessing Efficacy and Safety of TS-1 in Combination With Calcium Folinate in Patients With Heavily Pre-treated Metastatic Colorectal Cancer

Primary Objective:

To determine disease control rate (DCR) of TS-1® in patients with heavily pre-treated metastatic colorectal cancer

Secondary Objectives:

  • To determine objective response rate (ORR)
  • To determine time to progression (TTP)
  • To determine overall survival (OS)
  • To assess incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability]

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Simon's optimal two-stage design will be used to determine the sample size for this study.

• Stage I: >1/9: The first 9 evaluable patients enrolled, >1 (or ≥2) responders are required in order to enter the second stage, otherwise the trial will be terminated at the first stage due to futility.

• Stage II: Total >8/34: For the total 34 evaluable patients, >8 (or ≥9) responders are required to conclude the effectiveness of the study regimen.

The primary endpoint will be disease control rate which will be presented in frequency tabulation with two-sided 95% confidence interval (using binomial estimation).

The secondary endpoints are described as follows:

  • ORR will be presented in frequency tabulation with two-sided 95% confidence interval;
  • TTP will be estimated by Kaplan-Meier method with two-sided 95% confidence interval;
  • OS will be estimated by Kaplan-Meier method with two-sided 95% confidence interval;
  • Incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability] : assessed by CTCAE v4.0. Safety parameters will only be analyzed on the safety analysis set and be presented in frequency tabulation.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Linkou, Taiwan
        • Chang-Gung Memorial Hospital, Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. histologically or cytologically confirmed colorectal adenocarcinoma;
  2. metastatic and unresectable disease;

  3. presence of at least one measurable tumor lesion which is defined as lesion that can be measured in at least one dimension (longest diameter) with a minimum size of:

    1. 10mm by CT scan and MRI (no less than double the slice thickness and a minimum of 10mm);
    2. 20mm by conventional techniques;

  4. previously treatment to

    1. fluoropyrimidine, oxaliplatin and irinotecan;
    2. at least one targeted therapy

  5. adequate hematopoietic function which is defined as below:

    1. hemoglobin ≥ 9 g/dL;
    2. absolute neutrophil count (ANC) ≥ 1,500/mm3;
    3. platelet count ≥ 100,000/mm3;

  6. adequate hepatic function which is defined as below:

    1. total bilirubin ≤ 2 times upper limit of normal (ULN);
    2. hepatic transaminases (ALT and AST) ≤ 3 x ULN. If there are known liver metastases, ALT or AST must be ≤ 5 x ULN;

  7. adequate renal function which is defined as below:

    a. serum creatinine ≤ 1.5 x ULN;

  8. age of 20 years or above;
  9. ECOG performance status 0-2;
  10. life expectancy of at least 12 weeks;
  11. ability to take oral medication;
  12. ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

  1. history or known presence of brain metastasis;
  2. presence of mental disease or psychotic manifestation;
  3. significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigator's discretion;
  4. presence of diarrhea ≥ grade 2 in common terminology criteria for adverse event version 4.0 (CTCAE v4.0);
  5. other malignancy within the past 5 years (different site or histology) except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ;
  6. recent (within 30 days prior to study treatment) treatment of another investigational drug;
  7. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients with childbearing potential should have effective contraception for both the patient and his or her partner during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-1 + leucovorin
Single arm
Drug: S-1+leucovorin

Eligible patients will receive TS-1 orally 40-60 mg (depending on patient's body surface area (BSA)) in combination with calcium folinate 30 mg twice a day for 7 days in a 2-week cycle.

The treatment will be administered until disease progression, intolerable toxicity, or consent withdrawal during any time of the study.

Other Names:
  • TS-1+calcium folinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: 6 months(an expected average)
Documented objective response (OR) (defined as partial response [PR] or complete response [CR]), assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 at any time during trial participation by Investigator assessment
6 months(an expected average)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 6 months(an expected average)
the rate of completely response [CR] and partial response [PR] patients according to RECIST version 1.1. criteria
6 months(an expected average)
Time to Progression (TTP)
Time Frame: until disease progression, intolerable toxicity, 12 months(an expected average)
Participants follow-up for disease progression occur. Maximum follow-up time is 12 months after the initial administration of the last subject
until disease progression, intolerable toxicity, 12 months(an expected average)
Overall survival (OS)
Time Frame: at death or at the end of study, 24 months(an expected average)
median time between the start date of study treatment and the date of the death
at death or at the end of study, 24 months(an expected average)
Incidence of adverse events (AEs), serious adverse events (SAEs) [Safety and Tolerability]
Time Frame: From the date of study entry until 30 days after the last dose of study treatment
assessed by the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v4.0 and within some subgroups of patients
From the date of study entry until 30 days after the last dose of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TTY Biopharm

Collaborators

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Hung-Chih Hsu, Chang Gung Memorial Hospital, Linkou, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2014

Primary Completion (Actual)

June 18, 2015

Study Completion (Actual)

June 18, 2015

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 7, 2018

Study Record Updates

Last Update Posted (Actual)

May 7, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG1307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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