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

Inclusion criteria

• 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.

Exclusion criteria

• 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.