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

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ClinicalTrials.gov Identifier: NCT00077142
Recruitment Status : Completed
First Posted : February 11, 2004
Last Update Posted : October 31, 2018
National Cancer Institute (NCI)
Taiho Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Liver Cancer Drug: TAC-101 Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2001
Actual Primary Completion Date : July 2005
Actual Study Completion Date : August 2005

Arm Intervention/treatment
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077142

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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.
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Study Chair: Melanie B. Thomas, MD M.D. Anderson Cancer Center
Additional Information:
Publications of Results:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00077142    
Other Study ID Numbers: ID01-007
P30CA016672 ( U.S. NIH Grant/Contract )
MDA-ID-01007 ( Other Identifier: UT MD Anderson Cancer Center )
CDR0000349508 ( Registry Identifier: NCI PDQ )
First Posted: February 11, 2004    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
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:
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Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases