Expanded Access Study of TAS-102 in Patients With Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT02286492|
Expanded Access Status : Approved for marketing
First Posted : November 7, 2014
Last Update Posted : June 13, 2016
|Condition or disease||Intervention/treatment|
|Colorectal Cancer Metastatic||Drug: TAS-102|
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.
|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|
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286492