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

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Oncology, Inc.
• Treatments: Bevacizumab; Camptothecin; Irinotecan; Trifluridine

Criteria

Inclusion Criteria:

1. Has provided written informed consent

2. Has advanced gastrointestinal tumors refractory to at least 1 chemotherapy

3. ECOG performance status of 0 or 1

4. Is able to take medications orally

5. Has adequate organ function (bone marrow, kidney and liver)

6. 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:

1. 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

2. Presence of serious illnesses or medical condition(s) e.g. brain metastases, systemic infection, heart failure

3. Has unresolved toxicity of greater than or equal to CTCAE Grade 1 attributed to any prior therapies

4. Known sensitivity to TAS-102, CPT-11, Bevacizumab, or their components

5. Is a pregnant or lactating female

6. Has had either partial or total gastrectomy