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

Conditions

• Advanced Gastrointestinal Tumors

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.
• 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.

Study Details

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.

Key Dates

First listed

Aug 5, 2013

Start date

Sep 30, 2013

Status verified

Aug 2024

Primary completion

Sep 30, 2017

Completion

Sep 30, 2017

Study Design

Enrollment

65 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: TAS-102 and CPT-11 with or without Bevacizumab

Primary Outcome Measure

Determine maximum tolerated dose [ Time Frame: Through Cycle 1 and Cycle 2 (ie, 4 weeks) ]

Locations (4)

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