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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00754104
• Other study ID #: M10-371
• Status: Withdrawn
• Phase: Phase 1
• First received: September 15, 2008
• Last updated: January 17, 2011
• Start date: September 2008

Study information

• Verified date: January 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%.

Study Design

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• ABT-869
0.25 mg/kg. daily.
• Tarceva
150mg, daily.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics		Day 7, 15, 21, 35 and Day 1 of every 8 weeks	No