Spots Global Cancer Trial Database for Phase1 Study of Gemcitabine HCl Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lymphomas
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Trial Identification
Brief Title: Phase1 Study of Gemcitabine HCl Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lymphomas
Official Title: An Open Label, Phase 1, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Clinical Activity of Gemcitabine Hydrochloride Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lymphomas
Study ID: NCT01800630
Interventions
Study Description
Brief Summary: Open-label Phase 1 sequential dose-escalation study of 10 increasing doses (3 to 6 patients each)to determine and characterize the DLTs and MTD of gemcitabine HCl oral formulation (D07001-F4). Patients will be assigned to receive oral D07001-F4 on Days 1, 3, 5, 8, 10, and 12 of 4 21-day cycles each to further characterize safety and tolerability.
Detailed Description:
Keywords
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Contact Details
Name: Chia-Chi Lin, MD
Affiliation: National Taiwan University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Wu-Chou Su, MD
Affiliation: National Cheng-Kung University Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Yee Chao, MD
Affiliation: Taipei Veterans General Hospital, Taiwan
Role: PRINCIPAL_INVESTIGATOR
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