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A Single Arm, Open Label Study of First Line Treatment With Tarceva Plus Avastin on Progression-free Survival in Patients With Advanced or Metastatic Liver Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Liver Cancer

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Trial Information

A Single Arm, Open Label Study of First Line Treatment With Tarceva Plus Avastin on Progression-free Survival in Patients With Advanced or Metastatic Liver Cancer


Inclusion Criteria:



- adult patients, >=18 years of age;

- advanced or metastatic liver cancer;

- >=1 measurable lesion, not previously treated with local therapy within 4 weeks of
enrollment.

Exclusion Criteria:

- prior or concomitant systemic anti-cancer treatment for advanced disease;

- patients at high risk of variceal bleeding;

- clinically significant cardiovascular disease;

- major surgery, open biopsy, or significant traumatic injury within 4 weeks of study
start.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

Week 16

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Korea: Food and Drug Administration

Study ID:

ML21213

NCT ID:

NCT00605722

Start Date:

March 2008

Completion Date:

September 2010

Related Keywords:

  • Liver Cancer
  • Liver Neoplasms

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