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A Phase 1, Open Label Study of ABT-869 in Combination With Tarceva in Subjects With Advanced Non-hematologic Malignancy


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

Thank you

Trial Information

A Phase 1, Open Label Study of ABT-869 in Combination With Tarceva in Subjects With Advanced Non-hematologic Malignancy


Inclusion Criteria:



- Subject must have a histologically or cytologically confirmed non-hematologic
malignancy.

- Subject must have an ECOG Score of 0-2.

- Adequate organ function.

Exclusion Criteria:

- 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%.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pharmacokinetics

Outcome Time Frame:

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

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

M10-371

NCT ID:

NCT00754104

Start Date:

September 2008

Completion Date:

Related Keywords:

  • Solid Tumors

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