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

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Cancer

Intervention: TAC-101 (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Melanie B. Thomas, MD, Study Chair, Affiliation: M.D. Anderson Cancer Center


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).

Clinical Details

Official title: Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral TAC-101 in Patients With Advanced Hepatocellular Carcinoma

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Maximum Tolerated Dose (MTD) of TAC-101

Detailed description: OBJECTIVES: 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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.



- 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) Pulmonary

- 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


- 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 Surgery

- 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


- No other concurrent retinoids

Locations and Contacts

MD Anderson Cancer Center at University of Texas, Houston, Texas 77030-4009, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

UT MD Anderson Cancer Center website

Starting date: April 2001
Last updated: July 27, 2012

Page last updated: August 23, 2015

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