Know Cancer

or
forgot password

An Open-Label Study to Characterize the Pharmacokinetic Parameters of Erlotinib (Tarceva®, OSI-774) in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

Thank you

Trial Information

An Open-Label Study to Characterize the Pharmacokinetic Parameters of Erlotinib (Tarceva®, OSI-774) in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function


Inclusion Criteria:



- Histologically confirmed advanced solid tumor (measurable or nonmeasurable) that is
potentially responsive to erlotinib or for which no effective therapy is available,

- Cohort 1: Adequate hepatic function: bilirubin <= ULN, ALT (SGPT) and AST (SGOT) <=
1.5 x ULN or Cohort 2: Moderate hepatic function: 7-9 as assessed by the Child-Pugh
System, ECOG Performance Status 0-2

- Life expectancy >= 12 weeks,

- Prior radiation permitted provided that 4 weeks (or 2 weeks for palliative radiation)
has elapsed and patients have recovered from acute toxic effects of radiotherapy,

- Prior chemotherapy permitted provided that 4 weeks has elapsed and patients have
recovered from acute toxic effects of chemotherapy,

- Adequate hematopoietic and renal function: ANC >= 1.5 x 10^9/L, platelets >= 75 x
10^9/L, and creatinine <= 1.5 x ULN,

Exclusion Criteria:

- Use of tobacco or nicotine-containing products within 4 weeks of Day 1 and while on
study,

- Use of a CYP3A4 inhibitor or inducer within 14 days prior to Day 1 and until Day 5,

- Use of a warfarin-derivative anticoagulant within 14 days prior to Day 1 and until
Day 5,

- Encephalopathy >= grade 2,

- Significant history of cardiac disease unless well-controlled,

- Active or uncontrolled infections or serious illnesses or medical conditions that
could interfere with the patient's ongoing participation,

- Concurrent anticancer therapy or any other investigational agents within 4 weeks of
Day 1 and while on study,

- Symptomatic brain metastases that are not stable, require steroids, are potentially
life-threatening, or that have required radiation within the last 4 weeks,

- Gastro-intestinal abnormalities, including inability to take oral medication,
requirement for IV alimentation, active peptic ulcer or prior surgical procedures
affecting absorption.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

OSI-774-104

NCT ID:

NCT00139620

Start Date:

May 2005

Completion Date:

September 2007

Related Keywords:

  • Advanced Solid Tumors
  • advanced cancer, solid tumor
  • Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905
University of Colorado Health Sciences CenterDenver, Colorado  80262
Premiere OncologySanta Monica, California  90404
UPMC Cancer PavilionPittsburgh, Pennsylvania  15232