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Phase1 Study of Gemcitabine HCl Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lymphomas

NCT01800630 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2019-07-08

No results posted yet for this study

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.

Conditions

  • Advanced Solid Malignancies
  • Malignant Lymphomas

Interventions

DRUG

Gemcitabine HCl Oral Formulation

Sponsors & Collaborators

  • InnoPharmax Inc.

    lead INDUSTRY

Principal Investigators

  • Chia-Chi Lin, MD · National Taiwan University Hospital

  • Wu-Chou Su, MD · National Cheng-Kung University Hospital

  • Yee Chao, MD · Taipei Veterans General Hospital, Taiwan

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-11-30
Completion
2016-03-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01800630 on ClinicalTrials.gov