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

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.

Status
Withdrawn
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00386555
Enrollment
0
Registered
2006-10-11
Start date
2007-05-31
Completion date
Unknown
Last updated
2012-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Brief 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.

Interventions

DRUGdocetaxel
DRUGCP-868,596 + docetaxel
DRUGAG-013736 + docetaxel
DRUGCP-868,596 + AG-013736 + docetaxel

Sponsors

Arog Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Centrally-located tumors

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Determine the safety and tolerability of the combination of daily AG 013736 and docetaxel on an every 3 week schedule—
Determine the safety and tolerability of both CP 868,596 and AG 013736 given together with docetaxel on an every 3 week schedule—
Assess additional evidence of anti-tumor activity as measured by duration of objective response, progression-free survival, and one-year survival (OS1year)—
Determine the safety and tolerability of the combination of daily CP 868,596 and docetaxel on an every 3 week schedule—
Evaluate the PK of CP 868,596 when given in combination with docetaxel—
Evaluate the PK of docetaxel when given in combination with CP 868,596, or CP 868,596 plus AG 01373—
Evaluate the pharmacokinetics (PK) of AG 013736 and CP 868,596 when given together with and without docetaxel—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026