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

NCT01678690 | Completed Early Phase 1

• 1 other identifier: HR-11-001
• Study Type: interventional
• Target: 11
• Locations: 2 countries
• Sites: 4

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.

Conditions

Malignant Tumors

Outcome Measures

Primary Outcomes (1)

• gemcitabine (dFdC) and difluorodeoxyuridine (dFdU) plasma concentration and gemcitabine triphosphate (dFdCTP) concentration in PBMC

  Day 1-5

Secondary Outcomes (1)

• the proportion of subjects experiencing adverse events all grades, change from baseline in clinical laboratory test results, vital sign measurements, and physical examination findings

  Day 1-8 (+/- 1) days

Study Arms (1)

Gemcitabine HCl Oral Formulation

EXPERIMENTAL

Subjects will be treated with Gemcitabine HCl Oral Formulation according to assigned cohort (2 mg or 5 mg or 10 mg) on Day 1 of the 7-day study treatment period

Drug: Gemcitabine HCl Oral Formulation

Interventions

Gemcitabine HCl Oral Formulation DRUG

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

Also known as: D07001-F4

Gemcitabine HCl Oral Formulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 18 years and older.
• Signed and dated informed consent form.
• Subjects with malignancies with histological or pathologic confirmation and who are clinically stable.
• History of treatment with at least 1 cytotoxic chemotherapy regimen for the current malignancy.
• If the subject has received cytotoxic chemotherapy within the past 14 days, the subject is beyond the nadir of white blood cell and platelet counts.
• At least 28 days have elapsed since the subject's prior radiotherapy or any major surgery (excluding diagnostic biopsy or venous access device placement).
• World Health Organization (WHO) performance status 0 to 2
• Subject has an ANC ≥1500 cells/mm³, platelet count ≥ 100,000 cells/mm³, and hemoglobin ≥ 9 g/dL.
• Subject has adequate liver function demonstrated by transaminases within normal limits (aspartate transaminase and alanine transaminase), total bilirubin ≤ 1.5 mg/dL (unless due to Gilbert's syndrome), albumin ≥ 2.5 g/dL, international normalized ratio \[INR\] \< 1.5).
• Subject has adequate renal function: serum creatinine ≤ 1.5 x upper limit of normal.
• Subject has a life expectancy \>24 weeks.
• If a women of child-bearing potential, subject has a negative pregnancy test and is not breast-feeding.
• If a women of child-bearing potential, subject is using a medically acceptable form of birth control prior to screening and for the duration of their study participation and for 1 month after the end of the study.
• Subject is willing to comply with protocol-required visit schedule and visit requirements and provide written informed consent.

You may not qualify if:

• Subject has rapidly progressive disease or rapid clinical deterioration as assessed by the Investigator.
• Subject is receiving full-dose (therapeutic) anticoagulation therapy.
• Subject is receiving concomitant radiotherapy.
• Subject is intolerant or allergic or has a known hypersensitivity to gemcitabine.
• Subject has clinically significant cardiovascular disease (for example: uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association Grade 2 or greater).
• Subject has uncontrolled serious cardiac arrhythmia.
• Subject has known active brain metastases, or any leptomeningeal metastases.
• Subject has a history of drug or alcohol abuse within last year.
• Subject has documented cerebrovascular disease.
• Subject has a seizure disorder not controlled on medication.
• Subject received an investigational agent within 30 days of screening.
• Subject received systemic treatment for infection within 14 days of screening.
• Subject has known human immunodeficiency virus infection or viral hepatitis.
• Subject has any other serious medical condition that, in the investigator's medical opinion, would preclude safe participation in a clinical trial.
• Subject has gastrointestinal disease or prior gastrointestinal surgery that may interfere with adequate oral therapy absorption.

Sponsors & Collaborators

• InnoPharmax Inc.: lead

Study Sites (4)

Georgia Regents University- Cancer Center

Augusta, Georgia, 30912, United States

Location

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

Location

Gabrail Cancer Center Research

Dover, Ohio, 44622, United States

Location

National Taiwan University Hospital

Taipei, Taiwan, 10048, Taiwan

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Nashat Y. Gabrail, MD

  Gabrail Cancer Center Research

  PRINCIPAL INVESTIGATOR

• Sharad Ghamande, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

• Chia-Chi Lin, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2012
• First Posted: September 5, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 2, 2016

Record last verified: 2016-08

Locations

TW (1); US (3)