NCT00139620

Brief Summary

This is a multicenter, open-label, 2-arm study comparing erlotinib exposure in cancer patients with adequate hepatic function versus cancer patients with moderate hepatic impairment. All patients will receive a single 150 mg dose of erlotinib on Day 1 followed by 96 hours of plasma sampling for PK and protein binding studies. Patients may then enter the maintenance phase of the study and continue to receive erlotinib until disease progression or unacceptable toxicity.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2005

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2005

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2007

Completed
Last Updated

February 8, 2018

Status Verified

June 1, 2015

Enrollment Period

1.8 years

First QC Date

August 25, 2005

Last Update Submit

February 6, 2018

Conditions

Advanced Solid Tumors

Keywords

advanced cancer, solid tumor

Interventions

Tarceva, erlotinib, OSI-774DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Premiere Oncology

Santa Monica, California, 90404, United States

Location

University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

UPMC Cancer Pavilion

Pittsburgh, Pennsylvania, 15232, United States

Location

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Related Links

MeSH Terms

Interventions

Erlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 31, 2005

Study Start

August 22, 2005

Primary Completion

June 25, 2007

Study Completion

June 25, 2007

Last Updated

February 8, 2018

Record last verified: 2015-06

Locations

US(4)GB(1)