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Completed

NCT Number: NCT01916447

A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors.

The purpose of this study is to investigate the safety and determine the maximum tolerated dose of TAS-102 administered in combination with CPT-11 in patients with advanced gastrointestinal tumors.

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Key information

Conditions

Advanced Gastrointestinal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Los Angeles Clinical Site, Los Angeles, California, United States

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About this study

This is an open-label, non-randomized, dose-escalation, Phase 1 study of TAS-102 administered in combination with CPT-11. The study will be conducted in 2 parts: a Dose Escalation Phase (Part 1) to determine the maximum tolerated dose and an Expansion Phase (Part 2) to further evaluate the safety, pharmacokinetics, and preliminary efficacy of the maximum tolerated dose. Patients will be assigned to sequential dose-level cohorts with each cohort corresponding to a pre-specified dose of TAS-102 and CPT-11 combination. Escalation to the subsequent dose level will occur only after the previous dose level is determined to be safe.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Has provided written informed consent
  • Has advanced gastrointestinal tumors refractory to at least 1 chemotherapy
  • ECOG performance status of 0 or 1
  • Is able to take medications orally
  • Has adequate organ function (bone marrow, kidney and liver)
  • Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion criteria

  • Has had certain other recent treatment e.g. major surgery, extended field radiation, anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration
  • Presence of serious illnesses or medical condition(s) e.g. brain metastases, systemic infection, heart failure
  • Has unresolved toxicity of greater than or equal to CTCAE Grade 1 attributed to any prior therapies
  • Known sensitivity to TAS-102, CPT-11, Bevacizumab, or their components
  • Is a pregnant or lactating female
  • Has had either partial or total gastrectomy

Treatment and study plan

TAS-102

Drug

Escalating doses (20-35 mg/m2/dose, based on tolerability), orally, twice daily on days 1-5 of each 14-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.

CPT-11

Drug

Escalating doses (30-minute infusion of 120-180 mg/m2/dose, based on tolerability), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met.

Other names: camptothecin-11, irinotecan

Bevacizumab

Drug

Dose (infusion of 5 mg/kg administered per site standard practice), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met.

Other names: Avastin

Primary outcomes

  1. Determine maximum tolerated dose

    Time frame: Through Cycle 1 and Cycle 2 (ie, 4 weeks)

    The maximum tolerated dose is defined as the highest dose level at which less than 33% of the evaluable patients treated experience a dose-limiting toxicity during Cycle 1 or Cycle 2 (ie, during the first 4 weeks) of study drug administration.

  2. Safety monitoring including adverse events, vital signs, and laboratory assessments

    Time frame: Safety is assessed through 30 days following last administration of study medication or until initiation of new anticancer treatment.

    Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.

Secondary outcomes

  1. Investigate the safety of TAS-102 and CPT-11 at the MTD administered in combination with Bevacizumab (5 mg/kg IV).

    Time frame: Through 30 days following last administration of study medication or until initiation of new anticancer treatment

    Standard safety monitoring and grading using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) will be used.

  2. Investigate the clinical pharmacokinetics (PK) of TAS-102, CPT-11, and their metabolites.

    Time frame: Blood samples will be collected in Cycle 1 at pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 24 and 48 hours post AM dose of TAS-102 in combination with CPT-11.

    PK analysis for FTD, FTY, TPI, CPT-11, and SN-38 in plasma and will include Cmax, Tmax, AUC0-last, AUC0-inf, and T1/2. FTD and TPI: CL/F, Vd/F will be calculated.

  3. Document any preliminary antitumor activity of TAS-102 administered in combination with CPT-11 and in combination with CPT-11 and Bevacizumab.

    Time frame: After every 4 cycles (i.e., every 8 weeks)

    Tumor assessments using Response Evlauation Criteria in Solid Tumors (RECIST)

Sponsors and collaborators

Lead sponsor

Taiho Oncology, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-label, Non-randomized, Dose-escalating Safety, Tolerability, and Pharmacokinetic Study of TAS-102 in Combination With CPT-11 and Bevacizumab in Patients With Advanced Gastrointestinal Tumors

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 5, 2013
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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