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An Exploratory Study of Gemcitabine Hydrochloride Oral Formulation (D07001-F4) in Subjects With Malignant Tumors

NCT01678690 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2016-09-02

No results posted yet for this study

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.

Conditions

  • Malignant Tumors

Interventions

DRUG

Gemcitabine HCl Oral Formulation

Gemcitabine HCl Oral Formulation 80 mg/vial Subjects will be treated on Day 1 of the 7-day study treatment period

Sponsors & Collaborators

  • InnoPharmax Inc.

    lead INDUSTRY

Principal Investigators

  • Nashat Y. Gabrail, MD · Gabrail Cancer Center Research

  • Sharad Ghamande, MD · Augusta University

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

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States
  • 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 NCT01678690 on ClinicalTrials.gov