CP-751,871 In Combination With Docetaxel In Advance Non-hematologic Malignancies - Full Text View

Purpose

This clinical trial is designed to determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of escalating doses of CP 751,871 given in combination with docetaxel in patients with non-hematologic malignancies for whom docetaxel is a reasonable treatment option.

Condition	Intervention	Phase
Advanced Non-Hematologic Malignancies	Drug: CP-751,871 Drug: Docetaxel	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 1b Dose Escalation, Open-label Study Of CP-751,871 In Combination With Docetaxel In Advanced Non-hematologic Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Maximum tolerated dose [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 21 ] [ Designated as safety issue: Yes ]
Effect of CP-751,871 on docetaxel PK-Cmax [Maximum Observed Concentration] [ Time Frame: Prior to docetaxel C1-5; C1&C4: 30 and 50min post start docetaxel infusion and 30min, 1, 3, 8 and 24hr post end docetaxel infusion. Prior to CP-751,871 every cycle and 1hr post CP-751,871 C4 ] [ Designated as safety issue: No ]
Effect of CP-751,871 on docetaxel PK-Tmax [Time when maximum plasma concentration is reached] [ Time Frame: Prior to docetaxel C1-5; C1&C4: 30 and 50min post start docetaxel infusion and 30min, 1, 3, 8 and 24hr post end docetaxel infusion. Prior to CP-751,871 every cycle and 1hr post CP-751,871 C4 ] [ Designated as safety issue: No ]
Effect of CP-751,871 on docetaxel PK-AUClast [Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration] [ Time Frame: Prior to docetaxel C1-5; C1&C4: 30 and 50min post start docetaxel infusion and 30min, 1, 3, 8 and 24hr post end docetaxel infusion. Prior to CP-751,871 every cycle and 1hr post CP-751,871 C4 ] [ Designated as safety issue: No ]
Effect of CP-751,871 on docetaxel PK-AUC25 [Area under the plasma concentration-time profile from time zero to 25 hours postdose, the nominal time of the last sample (24 hours after end of infusion)] [ Time Frame: Prior to docetaxel C1-5; C1&C4: 30 and 50min post start docetaxel infusion and 30min, 1, 3, 8 and 24hr post end docetaxel infusion. Prior to CP-751,871 every cycle and 1hr post CP-751,871 C4 ] [ Designated as safety issue: No ]
Effect of CP-751,871 on docetaxel PK-AUClast(dn)[Dose-normalized AUClast] [ Time Frame: Prior to docetaxel C1-5; C1&C4: 30 and 50min post start docetaxel infusion and 30min, 1, 3, 8 and 24hr post end docetaxel infusion. Prior to CP-751,871 every cycle and 1hr post CP-751,871 C4 ] [ Designated as safety issue: No ]
Effect of CP-751,871 on docetaxel PK-Cmax(dn)[Dose-normalized Cmax] [ Time Frame: Prior to docetaxel C1-5; C1&C4: 30 and 50min post start docetaxel infusion and 30min, 1, 3, 8 and 24hr post end docetaxel infusion. Prior to CP-751,871 every cycle and 1hr post CP-751,871 C4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

PK of CP-751,871 given with docetaxel-Cmax [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit ] [ Designated as safety issue: No ]
PK of CP-751,871 given with docetaxel-Tmax [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit ] [ Designated as safety issue: No ]
PK of CP-751,871 given with docetaxel-Cday22[ Observed concentration on Day 22 of Cycle] [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit ] [ Designated as safety issue: No ]
PK of CP-751,871 given with docetaxel-AUClast [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit ] [ Designated as safety issue: No ]
PK of CP-751,871 given with docetaxel-Tlast[Time of last quantifiable time point] [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit ] [ Designated as safety issue: No ]
PK of CP-751,871 given with docetaxel-AUCtau [AUC from time zero to tau, the dosing interval, where tau is the actual time of the predose sample for the next cycle] [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit ] [ Designated as safety issue: No ]
PK of CP-751,871 given with docetaxel-AUC(0-d22) [AUC from time zero (Day 1) to Day 22, where Day 22 is the nominal time (504 hours) of the predose sample for the next cycle] [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit ] [ Designated as safety issue: No ]
PK of CP-751,871 given with docetaxel-AUC(0-d22)(dn)[Dose-normalized AUC(0-d22)] [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit ] [ Designated as safety issue: No ]
PK of CP-751,871 given with docetaxel-Rac [Observed accumulation ration] [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit ] [ Designated as safety issue: No ]
PK of CP-751,871 given with docetaxel-T1/2 [Terminal elimination half-life] [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit ] [ Designated as safety issue: No ]
PK of CP-751,871 given with docetaxel-AUCinf [AUC from time 0 extrapolated to infinity] [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit ] [ Designated as safety issue: No ]
PK of CP-751,871 given with docetaxel-CL [Clearance] [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit ] [ Designated as safety issue: No ]
PK of CP-751,871 given with docetaxel-Vss [Volume of distribution at steady state] [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit ] [ Designated as safety issue: No ]
PK of CP-751,871 given with docetaxel-Vz [Volume of distribution] [ Time Frame: Prior to CP-751,871 infusion each cycle; Cycles 1,2,3,4 at 1hr post infusion; Cycles 1&4 at 1,3,7 days post infusion. End of study and at each follow-up visit. ] [ Designated as safety issue: No ]
Biomarker: number of circulating tumor cells and their IGF-1R expression and circulating endothelial cells [ Time Frame: Predose on Days 1 and on Day 8 of each cycle and at the end of study ] [ Designated as safety issue: No ]
Presence of HAHA (human anti-human antibodies) [ Time Frame: Prior to each CP-751,871 infusion, end of study and 5th follow-up visit ] [ Designated as safety issue: Yes ]
Response Rate: Tumor assessment per RECIST criteria [ Time Frame: Every 2 months, approximately 7-10 days prior to start of next dosing cycle ] [ Designated as safety issue: No ]
Time to Progression: Tumor assessment per RECIST criteria [ Time Frame: Every 2 months, approximately 7-10 days prior to start of next dosing cycle ] [ Designated as safety issue: Yes ]

Enrollment:	46
Study Start Date:	March 2005
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CP-751,871 combined with docetaxel	Drug: CP-751,871 CP-751,871 was given intravenously [IV] every 3 weeks in escalating doses ranging from 0.1 mg/kg up to 20 mg/kg. Standard doses of Docetaxel were given every 3 weeks with CP-751,871. Study therapy was continued until disease progression, lack of tolerability for up to 17 cycles (approximately 1 year). Drug: Docetaxel Docetaxel up to 75 mg/m^2 was administered intravenously [IV] on Day 1 of each 3-week dosing cycle.

Arms

Assigned Interventions

Experimental: CP-751,871 combined with docetaxel

Drug: CP-751,871

CP-751,871 was given intravenously [IV] every 3 weeks in escalating doses ranging from 0.1 mg/kg up to 20 mg/kg.

Standard doses of Docetaxel were given every 3 weeks with CP-751,871. Study therapy was continued until disease progression, lack of tolerability for up to 17 cycles (approximately 1 year).

Drug: Docetaxel

Docetaxel up to 75 mg/m^2 was administered intravenously [IV] on Day 1 of each 3-week dosing cycle.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age greater than 18 years
Documented advanced-stage non-hematologic malignancy for whom docetaxel monotherapy is a reasonable treatment option
Eastern Cooperative Oncology Group [ECOG] performance status 0-1

Exclusion Criteria:

Significant active cardiac disease
Chemotherapy, biological or investigational agents within 4 weeks prior to dosing
Inadequate bone marrow, renal, cardiac or liver function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653158

Locations

United Kingdom
Pfizer Investigational Site
Sutton, Surrey, United Kingdom, SM2 5PT

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01653158 History of Changes
Other Study ID Numbers:	A4021003
Study First Received:	July 26, 2012
Last Updated:	July 27, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

non-hematologic cancer
advanced solid tumors
prostrate cancer

Additional relevant MeSH terms:

Neoplasms
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013