Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

Phase 1 Safety And Tolerability Study Of Figitumumab Combined With Pegvisomant In Patients With Advanced Solid Tumors

Sponsors

Lead Sponsor: Pfizer

Source Pfizer
Brief Summary

This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.

Detailed Description

This study was closed to enrollment on 18 April 2011 due to inability to recruit patients on a timely basis as well as business reasons. Study closure was not related to any safety concerns.

Overall Status Terminated
Start Date November 2009
Completion Date October 2012
Primary Completion Date September 2011
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) From Screening to the follow-up visit (90 days after last dose of figitimumab)
Number of Participants With Dose Limiting Toxicities (DLT) From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2
Secondary Outcome
Measure Time Frame
Serum Circulating Insulin-like Growth Factor (IGF-1) Levels Days 1 and 15 of Cycle 1 (Baseline); Day 1 of subsequent cycles starting from Cycle 2 to Cycle 27; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)
Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15
Maximum Observed Plasma Concentration (Cmax) of Figitumumab Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit
Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15
Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit
Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab Days 1, 2, 8 and 15 of Cycle 1; Day 1 of subsequent cycle starting from Cycle 2 (up to Cycle 17); end of treatment ( 21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Figitumumab Cycle 2: Day 1 (within 2 hours before and 1 hour after figitumumab infusion); Cycle 3 to Cycle 17: Day 1 (within 2 hours before figitumumab infusion); end of treatment; 90-day follow-up visit
Area Under the Trough Concentrations (AUCtrough) Cycle 1: Day 15 (within 2 hours before loading dose), Day 16 (within 2 hours pre-SC dose); Cycle 2: Days 1, 8 and 15 (within 2 hours pre-SC dose); Cycle 3 up to Cycle 17: Day 1 (within 2 hours pre-SC dose); end of treatment; 90-day follow-up visit
Mean Change in Glucose Levels Between Fasting and Post Glucose Load Screening; Day 8 of Cycle 1; Day 15 of Cycle 2
Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab Day 1 of Cycles 1 and 4; end of treatment (21 days after last dose of figitumumab); follow-up visit (90 days after last dose of figitumumab)
Number of Participants With Objective Response From Screening, odd numbered cycles (predose, Cycle 3, 5, 7 etc.) up to Cycle 27 or end of treatment visit (21 days after last dose of figitumumab)
Enrollment 24
Condition
Intervention

Intervention Type: Drug

Intervention Name: figitumumab

Description: IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year

Arm Group Label: 1

Other Name: CP-751,871

Intervention Type: Drug

Intervention Name: pegvisomant

Description: growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year

Arm Group Label: 1

Other Name: Somavert

Eligibility

Criteria:

Inclusion Criteria:

- Patients ≥18 years of age with advanced solid tumors for which the combination of figitumumab and pegvisomant are reasonable treatment options.

- Patients between the ages of 10 and 18 years with advanced sarcomas for which there is no available curative therapy or therapy proven to prolong survival with an acceptable quality of life will be included in the Sarcoma Expansion Cohort.

- Adequate recovery from prior therapies.

- Adequate organ function (i.e. bone marrow, kidney, liver)

- Total IGF-1 ≥100 ng/ml (13 nmol/L).

Exclusion Criteria:

- Concurrent treatment with any anti-tumor agents.

- Pregnant or breastfeeding females.

- Significant past history or active cardiac disease

- Active infection

- History of diabetes mellitus.

- Glycosylated hemoglobin >5.7

Gender: All

Minimum Age: 10 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
Facility:
Pfizer Investigational Site | Minneapolis, Minnesota, 55455, United States
Pfizer Investigational Site | Rochester, Minnesota, 55905, United States
Pfizer Investigational Site | Montreal, Quebec, H3T 1E2, Canada
Pfizer Investigational Site | Helsinki, 00290, Finland
Pfizer Investigational Site | Muenster, 48149, Germany
Location Countries

Canada

Finland

Germany

United States

Verification Date

October 2013

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: 1

Type: Experimental

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov