Study Of Anti-IGF-IR CP-751,871 In Patients With Solid Tumors

Sarcoma, Ewing's Clinical Trial

Official title:

Phase 1, Open Label, Multiple Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of CP 751,871 In Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474760
• Other study ID #: A4021010
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2007
• Last updated: October 25, 2013
• Start date: August 2005
• Est. completion date: October 2012

Study information

• Verified date: October 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a phase 1 study of anti-IGF-IR CP-751,871 in patients with solid tumors currently enrolling patients 9 years old and older with Ewing's sarcoma family of tumors (Ewing's, PNET and Askin's).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Ewing's sarcoma family tumors

Exclusion Criteria:

• Concurrent treatment with any other anti tumor agents

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma, Ewing
• Sarcoma, Ewing's

Intervention

Drug:
• CP-751,871
Currently dosing at 20 mg/kg, IV on day 1 of each 28 day cycle until progression or unacceptable toxicity

Locations

Country	Name	City	State
United Kingdom	Pfizer Investigational Site	Sutton	Surrey
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 150 days after last dose that were absent before treatment or that worsened relative to pretreatment state.	Baseline up to 150 days after the last administration of study drug	Yes
Secondary	Maximum Observed Plasma Concentration (Cmax) in Cycle 1		Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Maximum Observed Plasma Concentration (Cmax) in Cycle 4		Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 1		Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax) in Cycle 4		Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Plasma Decay Half-Life (t1/2) in Cycle 1	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Plasma Decay Half-Life (t1/2) in Cycle 4	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 1		Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Time to Reach Last Quantifiable Concentration (Tlast) in Cycle 4		Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Systemic Clearance (CL) in Cycle 1	CL is a quantitative measure of the rate at which a drug substance is removed from the body.	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Systemic Clearance (CL) in Cycle 4	CL is a quantitative measure of the rate at which a drug substance is removed from the body.	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Concentration at End of Infusion (Cendinf) in Cycle 1		Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Concentration at End of Infusion (Cendinf) in Cycle 4		Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Volume of Distribution (Vz) in Cycle 1	Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Volume of Distribution (Vz) in Cycle 4	Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Volume of Distribution at Steady State (Vss) in Cycle 1	Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Volume of Distribution at Steady State (Vss) in Cycle 4	Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the Vz at steady-state.	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 1	Area under the plasma concentration time-curve from zero to the last measured concentration	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) in Cycle 4	Area under the plasma concentration time-curve from zero to the last measured concentration	Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] in Cycle 1	Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0 - 8).	Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 1		Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Area Under the Plasma Concentration-time Profile From Time 0 to 504 Hours (21 Days) (AUC504) in Cycle 4		Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 1		Cycle 1: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Area Under the Plasma Concentration-time Profile From Time 0 to 672 Hours (28 Days) (AUC672) in Cycle 4		Cycle 4: 0 (predose), 1, 24 and 72 hours, 7 and 14 days postdose	No
Secondary	Human Anti-human Antibodies (HAHA) Levels	HAHA were indicators of immunogenicity to figitumumab.	30 minutes predose in Cycles 1 up to 61, and last scheduled follow-up visit (up to 150 days from the last dose of study drug)	No
Secondary	Number of Circulating Tumor Cells (CTCs)	Quantification of CTCs using an automated microscope system	30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort	No
Secondary	Number of Insulin-like Growth Factor 1 Receptor (IGF-1R) Positive CTCs	Quantification of IGF-IR positive CTCs using an automated microscope system	30 minutes predose in all cycles (up to 17); 1, 3, 7, and 14 days postdose in Cycle 1 for dose escalation and RP2D extension cohorts; and also 1 day postdose in Cycle 4 for RP2D extension cohort	No

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