Study of CP-751,871 in Combination With Docetaxel and Prednisone in Patients With Hormone Insensitive Prostate Cancer (HRPC)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00313781

First received: April 10, 2006

Last updated: March 5, 2013

Last verified: March 2013

History of Changes

Results First Received: January 18, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Prostatic Neoplasms
Interventions:	Drug: CP-751,871 Drug: docetaxel Drug: prednisone

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion intravenously (IV) over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21 days cycle, up to 17 cycles.
Docetaxel+Prednisone	Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
Docetaxel+Prednisone+CP-751,871 Crossover	Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.

Participant Flow for 2 periods

Period 1: Before Crossover

	CP-751,871+Docetaxel+Prednisone	Docetaxel+Prednisone
STARTED	102	102
Treated	97	102
COMPLETED	27	23
NOT COMPLETED	75	79
Death	22	8
Lost to Follow-up	0	3
Withdrawal by Subject	3	1
Unspecified	45	30
Crossover	0	37
Randomized, not treated	5	0

Period 2: After Crossover

	CP-751,871+Docetaxel+Prednisone	Docetaxel+Prednisone	Docetaxel+Prednisone+CP-751,871 Crossover
STARTED	0	0	37
COMPLETED	0	0	10
NOT COMPLETED	0	0	27
Death	0	0	6
Withdrawal by Subject	0	0	3
Unspecified	0	0	18

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
CP-751,871+Docetaxel+Prednisone	Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
Docetaxel+Prednisone	Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
Total	Total of all reporting groups

Baseline Measures

	CP-751,871+Docetaxel+Prednisone	Docetaxel+Prednisone	Total
Number of Participants [units: participants]	102	102	204
Age, Customized [units: Participants]
Less than (<) 18 years	0	0	0
18 to 44 years	0	1	1
45 to 64 years	26	32	58
Greater than or equal to (>=) 65 years	76	69	145
Gender [units: Participants]
Female	0	0	0
Male	102	102	204

Outcome Measures

Show All Outcome Measures

1. Primary:

Percentage of Participants With Prostate Specific Antigen (PSA) Best Response [ Time Frame: Baseline, Day 1 and Day 15 of each cycle, end of treatment (up to 28 days post last dose) and follow-up (monthly, up to 150 days post last dose) ]

Show Outcome Measure 1

2. Secondary:

Progression Free Survival (PFS) [ Time Frame: Baseline, Day 15 of each cycle and follow-up (monthly, up to 150 days post last dose) ]

Show Outcome Measure 2

3. Secondary:

Human Anti-human Antibody (HAHA) at Baseline (Day 1 of Cycle 1) [ Time Frame: Baseline (Day 1 of Cycle 1) ]

Show Outcome Measure 3

4. Secondary:

Human Anti-human Antibody (HAHA) at the Last Follow-up Visit [ Time Frame: The last follow-up visit (150 days post last dose) ]

Show Outcome Measure 4

5. Secondary:

Total Number of Circulation Tumor Cells (CTCs) [ Time Frame: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose) ]

Show Outcome Measure 5

6. Secondary:

Total Number of the Insulin Like Growth Factor Receptor Type 1 (IGF-1R) Positive CTCs [ Time Frame: Baseline, prior to dosing in odd numbered cycles (ie. Cycle 1, 3, 5, etc) and end of treatment (up to 28 days post last dose) ]

Show Outcome Measure 6

7. Secondary:

Quality of Life Measured by the Functional Assessment of Cancer Treatment‑Prostate (FACT‑P) [ Time Frame: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose) ]

Show Outcome Measure 7

8. Secondary:

Pain Measured by the Modified Brief Pain Inventory‑Short Form (mBPI‑sf Modified Pfizer) [ Time Frame: Baseline, Cycle 1 to Cycle 10 before drug administration and end of treatment (up to 28 days post last dose) ]

Show Outcome Measure 8

9. Secondary:

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) for CP-751,871 [ Time Frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose) ]

Show Outcome Measure 9

10. Secondary:

Maximum Observed Plasma Concentration (Cmax) for CP-751,871 [ Time Frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose) ]

Show Outcome Measure 10

11. Secondary:

Minimum Observed Plasma Trough Concentration (Cmin) for CP-751,871 [ Time Frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose) ]

Show Outcome Measure 11

12. Secondary:

Area Under the Curve From Time Zero to End of Dosing Interval (AUC0-tau) for CP-751,871 [ Time Frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose) ]

Show Outcome Measure 12

13. Secondary:

Population PK Parameters of CP-751,871 [ Time Frame: Days 1, 8 and 15 of each cycle and last follow-up visit (150 days post last dose) ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00313781 History of Changes
Other Study ID Numbers:	A4021011
Study First Received:	April 10, 2006
Results First Received:	January 18, 2013
Last Updated:	March 5, 2013
Health Authority:	United States: Food and Drug Administration

To Top