Clinical trial NCT00976508: Figitumumab Combined With Pegvisomant For Advanced Solid Tumors
Official title: Phase 1 Safety And Tolerability Study Of Figitumumab Combined With Pegvisomant In Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Colorectal Neoplasms
Lung Neoplasms
Breast Neoplasms
Prostatic Neoplasms
Sarcoma
Keywords: advanced solid tumors cancer refractory cancer figitumumab pegvisomant
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-14
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Screening to the follow-up visit (90 days after last dose of figitimumab)
measure: Number of Participants With Dose Limiting Toxicities (DLT)
timeFrame: From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2
Secondary outcomes:
measure: Serum Circulating Insulin-like Growth Factor (IGF-1) Levels
timeFrame: 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)
measure: Cycle 1: Maximum Observed Plasma Concentration (Cmax) of Figitumumab
timeFrame: Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15
measure: Maximum Observed Plasma Concentration (Cmax) of Figitumumab
timeFrame: 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
measure: Cycle 1: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab
timeFrame: Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15
measure: Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab
timeFrame: 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
measure: Cycle 1: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Figitumumab
timeFrame: 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)
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)of Figitumumab
timeFrame: 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
measure: Area Under the Trough Concentrations (AUCtrough)
timeFrame: 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
measure: Mean Change in Glucose Levels Between Fasting and Post Glucose Load
timeFrame: Screening; Day 8 of Cycle 1; Day 15 of Cycle 2
measure: Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab
timeFrame: 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)
measure: Number of Participants With Objective Response
timeFrame: 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)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: