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TAC-101 in Treating Patients With Advanced Hepatocellular Carcinoma (Liver Cancer)

This study has been completed.
National Cancer Institute (NCI)
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: February 10, 2004
Last updated: July 27, 2012
Last verified: July 2012

RATIONALE: TAC-101 may stop the growth of cancer by stopping blood flow to the tumor.

PURPOSE: This phase I/II trial is studying the side effects and best dose of TAC-101 and to see how well it works in treating patients with advanced hepatocellular carcinoma (liver cancer).

Condition Intervention Phase
Liver Cancer
Drug: TAC-101
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral TAC-101 in Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of TAC-101 [ Time Frame: 60 Days ]

Enrollment: 37
Study Start Date: April 2001
Study Completion Date: August 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAC-101
Oral TAC-101 daily Days 1-14, repeats every 21 days for 2 courses.
Drug: TAC-101
Once daily by mouth on days 1-14, repeat every 21 days for 2 courses.

Detailed Description:


Phase I

  • Primary

    • Determine the maximum tolerated dose (MTD) of TAC-101 in patients with advanced hepatocellular carcinoma.
    • Determine the safety of 2 consecutive courses of this drug in these patients.
    • Determine the pharmacokinetics of this drug in these patients.
    • Determine the toxic and adverse effects profile of this drug in these patients.

Phase II

  • Primary

    • Determine the objective antitumor response rate in patients treated with this drug at the MTD.
  • Secondary

    • Determine the overall survival time of patients treated with this drug.
    • Determine the time to disease progression in patients treated with this drug.
    • Determine the duration of observed objective response, using WHO criteria and measurements of serum alpha-fetoprotein concentrations, in patients treated with this drug.
    • Determine the time to treatment failure in patients treated with this drug.
    • Determine the safety and tolerability of intermittent treatment with this drug in these patients.

OUTLINE: This is an open-label, dose-escalation study.

  • Phase I: Patients receive oral TAC-101 once daily on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of TAC-101 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

  • Phase II: Patients receive oral TAC-101 at the MTD (determined in phase I) once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 35-60 days.

PROJECTED ACCRUAL: A total of 6-18 patients for the phase I portion and 21-41 patients for the phase II portion will be accrued for this study.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed hepatocellular carcinoma
  • At least 1 previously unirradiated, bidimensionally measurable lesion greater than 20 mm by MRI or conventional CT scan OR at least 10 mm by spiral CT scan
  • Patients with CNS involvement must have completed appropriate treatment and have no progressive neurologic deficits within the past 28 days
  • No carcinomatous meningitis



  • 18 to 80

Performance status

  • ECOG 0-2

Life expectancy

  • More than 12 weeks


  • Hemoglobin ≥ 10.0 g/dL
  • WBC ≥ 2,000/mm^3
  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 40,000/mm^3
  • No abnormal bleeding or clotting


  • No grade C Child-Pugh cirrhosis
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Albumin ≥ 2.8 g/dL
  • INR ≤ 1.5 times ULN
  • Bilirubin ≤ 2.0 mg/dL


  • Creatinine ≤ 1.5 times ULN


  • No prior deep vein thrombosis
  • No prior superficial venous thrombosis
  • No family history of thromboembolism in a first-degree relative
  • No lower extremity thromboses by Doppler ultrasound (unless a subsequent venous angiography confirms a false positive ultrasound)


  • No prior pulmonary embolism


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception, except oral contraceptives containing estrogen
  • Fasting triglycerides ≤ 400 mg/dL for men or ≤ 325 mg/dL for women
  • No other malignancy within the past 3 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No uncontrolled metabolic disorders, other nonmalignant organ or systemic disease, or secondary effects of cancer that induce a high medical risk
  • No known allergy or hypersensitivity to TAC-101 or its components


Biologic therapy

  • No prior thalidomide
  • No prior putative antiangiogenesis therapy
  • Prior interferon allowed


  • No more than 2 prior chemotherapy regimens

Endocrine therapy

  • No concurrent estrogen products


  • See Disease Characteristics
  • More than 21 days since prior radiotherapy, except small portal radiotherapy used for the palliation of isolated, symptomatic, osseous metastases
  • No prior radiotherapy to evaluable lesions
  • No concurrent radiotherapy unless for bone pain that is present before beginning study


  • Not specified


  • Prior anticancer treatment allowed provided there is clear evidence of progressive disease after the most recent treatment
  • More than 21 days since prior anticancer therapy and recovered
  • No more than 2 prior treatment regimens
  • No concurrent therapeutic anticoagulants

    • Concurrent low-dose warfarin for prophylactic care of indwelling venous access devices allowed
  • No concurrent azoles or tetracyclines
  • No concurrent medications known or suspected to increase risk of venous thromboembolism
  • No other concurrent retinoids
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Please refer to this study by its identifier: NCT00077142

United States, Texas
MD Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Taiho Pharmaceutical Co., Ltd.
Study Chair: Melanie B. Thomas, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00077142     History of Changes
Other Study ID Numbers: ID01-007
P30CA016672 ( US NIH Grant/Contract Award Number )
MDA-ID-01007 ( Other Identifier: UT MD Anderson Cancer Center )
CDR0000349508 ( Registry Identifier: NCI PDQ )
Study First Received: February 10, 2004
Last Updated: July 27, 2012

Keywords provided by M.D. Anderson Cancer Center:
advanced adult primary liver cancer
recurrent adult primary liver cancer
adult primary hepatocellular carcinoma
localized unresectable adult primary liver cancer
Oral TAC-101

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on April 28, 2017