An Open-Label, Exploratory, Limited Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors
Phase of Trial: Phase 0
Latest Information Update: 16 Sep 2016
At a glance
- Drugs Gemcitabine (Primary)
- Indications Solid tumours
- Focus Pharmacokinetics
- Sponsors INNOPHARMAX
- 02 Jun 2015 Based on the absence of drug-related adverse events, it was concluded that single doses used in this study were were safe and well-tolerated and another phase I study has been initiated to determine the maximum tolerated dose , according to an ASCO abstract.
- 02 Jun 2015 Results presented at the 51st Annual Meeting of the American Society of Clinical Oncology.
- 19 May 2014 Trial status changed to completed as reported by ClinicalTrials.gov.