Spots Global Cancer Trial Database for An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors
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Trial Identification
Brief Title: An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors
Official Title: 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
Study ID: NCT01678690
Conditions
Interventions
Study Description
Brief Summary: Open-label, Phase 0, dose-escalation study of 3 successive cohorts (3 subjects per cohort), to determine and characterize the plasma PK of gemcitabine HCl oral formulation (D07001-F4) administered once on Day 1 with 7 Days of study follow-up. In addition, oral tolerability and safety will also be assessed during this 1-week period.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Georgia Regents University- Cancer Center, Augusta, Georgia, United States
Gabrail Cancer Center Research, Canton, Ohio, United States
Gabrail Cancer Center Research, Dover, Ohio, United States
National Taiwan University Hospital, Taipei, , Taiwan
Contact Details
Name: Nashat Y. Gabrail, MD
Affiliation: Gabrail Cancer Center Research
Role: PRINCIPAL_INVESTIGATOR
Name: Sharad Ghamande, MD
Affiliation: Augusta University
Role: PRINCIPAL_INVESTIGATOR
Name: Chia-Chi Lin, MD
Affiliation: National Taiwan University Hospital
Role: PRINCIPAL_INVESTIGATOR
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