NCT00754104

Brief Summary

Study of ABT-869 in Combination with Tarceva in Subjects with Solid Tumors

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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

September 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2009

Enrollment Period

3 months

First QC Date

September 15, 2008

Last Update Submit

January 17, 2011

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    Day 7, 15, 21, 35 and Day 1 of every 8 weeks

Study Arms (1)

A

EXPERIMENTAL
Drug: ABT-869Drug: Tarceva

Interventions

ABT-869DRUG

0.25 mg/kg. daily.

A
TarcevaDRUG

150mg, daily.

A

Eligibility Criteria

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

You may qualify if:

  • Subject must have a histologically or cytologically confirmed non-hematologic malignancy.
  • Subject must have an ECOG Score of 0-2.
  • Adequate organ function.

You may not qualify if:

  • Subject has received targeted VEGF/PDGF therapy (tyrosine kinase inhibitor) therapy. Prior Avastin allowed.
  • Subject has untreated brain or meningeal metastases.
  • History of greater than 10% weight loss.
  • Has clinically relevant hemoptysis.
  • Subject has proteinuria CTC grade \> 1.
  • Must not have had radiation therapy or major surgery within 21 days of study day 1.
  • The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (DBP) \> 100 mmHg or systolic blood pressure (SBP) \> 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 (LVEF) \< 50%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

linifanibErlotinib Hydrochloride

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds
0

Study Design

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

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 17, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2008

Last Updated

January 19, 2011

Record last verified: 2009-01