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

NCT01800630 | Completed Phase 1

• 1 other identifier: HR-12-001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 3

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.

Conditions

Advanced Solid Malignancies; Malignant Lymphomas

Outcome Measures

Primary Outcomes (1)

• To determine MTD and DLT of Gemcitabine Oral formulation

  MTD will be determined by study structure and DLT will be determined by definition

  During the 21-day cycle 1 treatment

Secondary Outcomes (4)

• AE/SAE incidences

  Throughout treatment and 30-day follow-up (estimated average of 5 months)

• Changes from baseline in clinical laboratory test (hematology, biochemistry, coagulation factors and urinalysis) results, vital sign measurements, physical examination findings, and ECG and 2D echocardiogram/multiple-gated acquisition (MUGA) scan results

  Throughout treatment and 30-day follow-up (estimated average of 5 months)

• characterize the PK of D07001-F4

  cycle 0 and cycle 1 (Day -7~Day 19)

• ORR(Objective Response Rate) and tumor response

  After cycle 2 and cycle 4 treatments (estimated average of 2 months and 4 months)

Study Arms (1)

Gemcitabine HCl Oral Formulation (D07001-F4)

EXPERIMENTAL

Subjects will receive a single 5-mg (nontherapeutic) dose of gemcitabine (Gemzar®) via an IV push and then treated with Gemcitabine HCl Oral Formulation (D07001-F4)according to assigned cohort (2 mg to 80 mg) on Day 1, 3, 5, 8, 10, and 12 of 4 21-day cycles study treatment period.

Drug: Gemcitabine HCl Oral Formulation

Interventions

Gemcitabine HCl Oral Formulation DRUG

Also known as: D07001-F4

Gemcitabine HCl Oral Formulation (D07001-F4)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 20 years and older
• Signed and dated informed consent form
• Patients with advanced solid malignancies and malignant lymphomas with histological or pathologic confirmation who have failed standard therapies or for which no standard therapy exists
• Both measurable and non-measurable disease allowed (measurable disease per RECIST, version 1.1, or Revised Response Criteria for Malignant Lymphoma \[Cheson criteria\])
• World Health Organization (WHO) performance status 0 to 2
• At least 28 days have elapsed (before screening) since the patient's prior systemic therapy, radiotherapy, or any major surgery (excluding diagnostic biopsy or venous access device placement)
• Patient has
• Absolute neutrophil count (ANC) ≥ 1500 cells/mm³
• Platelet count ≥ 75,000 cells/mm³
• Hemoglobin ≥ 9 g/dL.
• Patient has adequate liver function, demonstrated by:
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5\*the upper limit of normal (ULN) (≤ 5.0\*ULN in case of liver metastasis)
• Total bilirubin ≤ 1.5 mg/dL (unless due to Gilbert's syndrome)
• Albumin ≥ 2.5 g/dL
• International normalized ratio (INR) \< 1.5

You may not qualify if:

• Patient is receiving full-dose (therapeutic) anticoagulation therapy.
• Patient is intolerant or allergic or has a known hypersensitivity to gemcitabine
• Patient has clinically significant cardiovascular disease (for example: uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association Grade 2 or greater).
• Patient has uncontrolled serious cardiac arrhythmia.
• Patient has known brain metastases or any leptomeningeal metastases.
• Patient has received radiotherapy of more than 10 Gy within 6 months of screening.
• Patient has a history of drug or alcohol abuse within last year.
• Patient has documented cerebrovascular disease.
• Patient has a seizure disorder not controlled on medication (based on decision of Investigator).
• Patient received an investigational agent within 28 days of screening
• Patient received systemic treatment for infection within 14 days of screening.
• Patient has known human immunodeficiency virus (HIV) infection.
• Patient has hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection in medical history.
• Patient has received yellow fever vaccine and other live attenuated vaccines within the last 4 weeks
• Patient has any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in a clinical trial.

Sponsors & Collaborators

• InnoPharmax Inc.: lead

Study Sites (3)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Chia-Chi Lin, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Wu-Chou Su, MD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

• Yee Chao, MD

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 23, 2013
• First Posted: February 28, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2016
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

TW (3)