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Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT02286492
Expanded Access Status : Approved for marketing
First Posted : November 7, 2014
Last Update Posted : June 13, 2016
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Brief Summary:
The objective of the program is to provide access to TAS-102 to patients with metastatic colorectal cancer who are refractory to or failing standard chemotherapy, are new to therapy with TAS-102 and in whom therapy with TAS-102 is clinically indicated.

Condition or disease Intervention/treatment
Colorectal Cancer Metastatic Drug: TAS-102

Detailed Description:

This is an open-label study to provide expanded access to TAS-102 prior to its commercial availability for patients with metastatic colorectal cancer who have been previously treated with, or are not candidates for fluoropyrimidine-, irinotecan-, and oxaliplatin-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) therapy, and an anti-epidermal growth factor receptor (EGFR) therapy.

Serious adverse event information (whether or not related to TAS-102) as well as reports of pregnancy, overdose, or medication error will reported. In addition, all grades of adverse drug reactions (ADRs, adverse events related to study medication) and any adverse event that results in treatment discontinuation will be recorded as study data on CRFs.

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Study Type : Expanded Access
Official Title: An Open-Label Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer Refractory to or Failing Standard Chemotherapy

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: TAS-102
    At a dose of 35 mg/m2 administered orally twice daily for 5 days a week with 2 days rest for 14 days, followed by a 14-day rest (1 treatment cycle)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. Has provided written informed consent
  2. Has adenocarcinoma of the colon or rectum
  3. Has failed at least 2 prior regimens of standard chemotherapies for metastatic colorectal cancer
  4. ECOG performance status of 0 or 1
  5. Is able to take medications orally
  6. Has adequate organ function (bone marrow, kidney and liver)
  7. 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. Certain serious illnesses or medical condition(s)
  2. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, within the specified time frames prior to study drug administration
  3. Has received TAS-102
  4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
  5. Is a pregnant or lactating female

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286492

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Sponsors and Collaborators
Taiho Oncology, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02286492    
Other Study ID Numbers: TO-TAS-102-401
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: June 13, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases