| January 3, 2008 |
| November 11, 2009 |
| March 2008 |
| July 2011 (final data collection date for primary outcome measure) |
| Overall Survival (OS) [ Time Frame: 3 years ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00596830 on ClinicalTrials.gov Archive Site |
- Overall objective response rate (ORR) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Progression Free Survival (PFS) [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- Overall safety profile [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Patient reported outcomes (PROs) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Pharmacokinetics of CP 751,871 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Anti drug antibody occurrence [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Change in serum IGF1 levels [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| Carboplatin And Paclitaxel With Or Without CP-751, 871 (An IGF-1R Inhibitor) For Advanced NSCLC Of Squamous, Large Cell And Adenosquamous Carcinoma Histology |
| Randomized, Open Label, Phase III Trial Of CP- 751,871 In Combination With Paclitaxel And Carboplatin Versus Paclitaxel And Carboplatin In Patients With Non Small Cell Lung Cancer |
Determine whether the addition of CP 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with locally advanced (Stage IIIB with pleural effusion) or metastatic (Stage IV or recurrent) NSCLC of non adenocarcinoma histology. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
- Carcinoma, Squamous Cell
- Carcinoma, Adenosquamous
- Carcinoma, Large Cell
- Carcinoma, Non-Small-Cell Lung
|
- Drug: CP-751,871 + Carboplatin +Paclitaxel
- Drug: Carboplatin + Paclitaxel
|
- Experimental: Patients in Arm A will receive CP-751, 871 in combination with paclitaxel and carboplatin intravenously every 21 days for up to six cycles.`
- Active Comparator: Patient in Arm B will receive paclitaxel and carboplatin intravenously every 21 days for up to six cycles.
|
| |
| |
| Suspended |
| 820 |
| July 2011 |
| July 2011 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Confirmed diagnosis of non small cell lung cancer with a primary histology of predominantly squamous cell, large cell or adenosquamous carcinoma.
- Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease.
- No prior systemic treatment for NSCLC, except for adjuvant chemotherapy. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to randomization.
- Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to randomization and all acute toxicities have resolved.
- ECOG performance status (PS) 0 or 1.
Exclusion Criteria:
- Patients with symptomatic central nervous system (CNS) metastases are not permitted.
- Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted.
- Patients with other active cancer types are not permitted.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Australia, Austria, Brazil, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Poland, Puerto Rico, Russian Federation, Slovakia, Spain, Switzerland, Taiwan, Turkey, Ukraine |
| |
| NCT00596830 |
| Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| A4021016 |
| Pfizer |
|
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
|
| Pfizer |
| November 2009 |
