Study of ABT-869 in Combination With Tarceva in Subjects With Solid Tumors
This study has been withdrawn prior to enrollment.
Sponsor:
Abbott
Collaborator:
Genentech
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00754104
First received: September 15, 2008
Last updated: January 17, 2011
Last verified: January 2009
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Purpose
Study of ABT-869 in Combination with Tarceva in Subjects with Solid Tumors
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumors |
Drug: ABT-869 Drug: Tarceva |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Open Label Study of ABT-869 in Combination With Tarceva in Subjects With Advanced Non-hematologic Malignancy |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Pharmacokinetics [ Time Frame: Day 7, 15, 21, 35 and Day 1 of every 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | September 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: ABT-869
0.25 mg/kg. daily.
Other Name: ABT-869
Drug: Tarceva
150mg, daily.
Other Name: Tarceva
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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%.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Rod Humerickhouse, Global Project Head, Oncology, Abbott |
| ClinicalTrials.gov Identifier: | NCT00754104 History of Changes |
| Other Study ID Numbers: | M10-371 |
| Study First Received: | September 15, 2008 |
| Last Updated: | January 17, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013