NCT00517920

Phase 2 Study of an Active Drug in Advanced Hepatocellular Carcinoma (HCC)

Brief summary

Phase 2 Study of an active drug in Advanced Hepatocellular Carcinoma (HCC)

Interventional study

Status:
Completed
Conditions:
Advanced Hepatocellular Carcinoma
Enrollment:
44 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M06-879
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Masking:
None (Open Label)
Purpose:
Treatment

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Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria

- Subject must be greater than or equal to 18 years of age

- Subject must be diagnosed with unresectable or metastatic HCC

- Subjects must have a measurable lesion by RECIST on CT scan in at least one site which
has not received radiation

- Subject has an Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2

- No other active malignancy within the past 5 years

Exclusion Criteria

- Subject has received targeted VEGF/PDGF/TKI therapy. Prior Avastin is allowed

- Subject has Child-Pugh grade Class C hepatic impairment

- The subject has proteinuria Common Toxicity Criteria (CTC) grade > 1 as measured by
routine urinalysis or 24 hour urine collection during screening assessment

- Subject currently exhibits symptomatic or persistent, uncontrolled hypertension
defined as diastolic blood pressure > 100 mmHg or systolic blood pressure > 150 mmHg.
Subjects may be re-screened if blood pressure is shown to be controlled with or
without intervention

- The subject has a documented left ventricular Ejection Fraction < 50%

- Subject is receiving therapeutic anticoagulation therapy

All the cities where the clinical studies are located

Vancouver - V5Z 4E6
Toronto - M5G 2M9

British Columbia

Ontario