A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel.

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Phase 2 Study of CP-868,596 + Docetaxel, AG-013736 + Docetaxel, or CP-868,596 + AG-013736 + Docetaxel and of Docetaxel Alone in Patients With Stage IIIb or IV Non-Small Cell Lung Cancer.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00386555
• Other study ID #: A5301010
• Status: Withdrawn
• Phase: Phase 2
• First received: October 6, 2006
• Last updated: August 7, 2012
• Start date: May 2007

Study information

• Verified date: May 2007
• Source: Arog Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To determine the effectiveness of CP-868,596 + docetaxel, AG-013736 + docetaxel and CP-868,596 + AG-013736 + docetaxel in patients previously treated for non-small cell lung cancer.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Platinum-pretreated patients with advanced stage IIIb or IV NSCLC

Exclusion Criteria:

• Centrally-located tumors

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• docetaxel

• CP-868,596 + docetaxel

• AG-013736 + docetaxel

• CP-868,596 + AG-013736 + docetaxel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arog Pharmaceuticals, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the anti-tumor efficacy of CP 868,596 plus docetaxel, AG 013736 plus docetaxel, CP 868,596 plus AG 013736 plus docetaxel, and docetaxel alone in patients with advanced NSCLC based on objective tumor response (CR and PR) rate
Secondary	Determine the safety and tolerability of the combination of daily CP 868,596 and docetaxel on an every 3 week schedule
Secondary	Determine the safety and tolerability of the combination of daily AG 013736 and docetaxel on an every 3 week schedule
Secondary	Determine the safety and tolerability of both CP 868,596 and AG 013736 given together with docetaxel on an every 3 week schedule
Secondary	Assess additional evidence of anti-tumor activity as measured by duration of objective response, progression-free survival, and one-year survival (OS1year)
Secondary	Evaluate the pharmacokinetics (PK) of AG 013736 and CP 868,596 when given together with and without docetaxel
Secondary	Evaluate the PK of CP 868,596 when given in combination with docetaxel
Secondary	Evaluate the PK of docetaxel when given in combination with CP 868,596, or CP 868,596 plus AG 01373

External Links

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