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WithdrawnNCT00386555Updated Aug 9, 2012

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

A Phase 2 interventional study of docetaxel and CP-868,596 + docetaxel in Carcinoma, Non-Small-Cell Lung, sponsored by Arog Pharmaceuticals, Inc.. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-09.

Sponsored by Arog Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Study was cancelled before patient enrollment
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Arog Pharmaceuticals, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Centrally-located tumors
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • Drugdocetaxel
  • DrugCP-868,596 + docetaxel
  • DrugAG-013736 + docetaxel
  • DrugCP-868,596 + AG-013736 + docetaxel
06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. Determine the safety and tolerability of the combination of daily CP 868,596 and docetaxel on an every 3 week schedule

  2. Determine the safety and tolerability of the combination of daily AG 013736 and docetaxel on an every 3 week schedule

  3. Determine the safety and tolerability of both CP 868,596 and AG 013736 given together with docetaxel on an every 3 week schedule

  4. Assess additional evidence of anti-tumor activity as measured by duration of objective response, progression-free survival, and one-year survival (OS1year)

  5. Evaluate the pharmacokinetics (PK) of AG 013736 and CP 868,596 when given together with and without docetaxel

  6. Evaluate the PK of CP 868,596 when given in combination with docetaxel

  7. Evaluate the PK of docetaxel when given in combination with CP 868,596, or CP 868,596 plus AG 01373

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00386555
Lead sponsor
Arog Pharmaceuticals, Inc.
First posted
Oct 11, 2006
Start date
May 2007
Last update
Aug 9, 2012

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2007. You cannot join it, but the record below documents what was studied.

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