Figitumumab Combined With Pegvisomant For Advanced Solid Tumors

NCT00976508 | Terminated Phase 1 Results

• 1 other identifier: A4021040
• Study Type: interventional
• Target: 24
• Locations: 4 countries
• Sites: 5

Brief Summary

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

Conditions

Colorectal Neoplasms; Lung Neoplasms; Breast Neoplasms; Prostatic Neoplasms; Sarcoma

Keywords

advanced solid tumors cancer refractory cancer figitumumab pegvisomant

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. AEs were graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 (Grade \[Gr\] 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death). Relatedness to \[study drug\] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

  From Screening to the follow-up visit (90 days after last dose of figitimumab)

• Number of Participants With Dose Limiting Toxicities (DLT)

  DLT was defined as any of the following events occurring during DLT period and considered related to study medication: Grade (Gr) 4 neutropenia lasting \>=7 days, febrile neutropenia (Gr 3 or 4 neutropenia, fever \>=38.5 degrees Celsius, lasting over 24 hours), neutropenic infection (Gr \>=3 neutropenia, infection); Gr 3 or 4 thrombocytopenia associated with bleeding or Gr 4 thrombocytopenia \>=7 days; Gr 3 or 4 lymphopeniab accompanied by an opportunistic infection; other non-hematologic Grade 4 toxicities or symptomatic Gr 3 toxicities that require medical intervention and 14 days to resolve.

  From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2

Secondary Outcomes (11)

• 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

Study Arms (1)

1

EXPERIMENTAL

Drug: figitumumab; Drug: pegvisomant

Interventions

figitumumab DRUG

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

Also known as: CP-751,871

1

pegvisomant DRUG

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

Also known as: Somavert

1

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Pfizer Investigational Site

Minneapolis, Minnesota, 55455, United States

Location

Pfizer Investigational Site

Rochester, Minnesota, 55905, United States

Location

Pfizer Investigational Site

Montreal, Quebec, H3T 1E2, Canada

Location

Pfizer Investigational Site

Helsinki, 00290, Finland

Location

Pfizer Investigational Site

Münster, 48149, Germany

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Colorectal Neoplasms; Lung Neoplasms; Breast Neoplasms; Prostatic Neoplasms; Sarcoma

Interventions

figitumumab; pegvisomant

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Limitations and Caveats

The study was terminated prematurely due to lack of operational feasibility and the halt of figitumumab development.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 14, 2009
• Study Start: November 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2012
• Last Updated: December 13, 2013
• Results First Posted: December 13, 2013

Record last verified: 2013-10

Locations

CA (1); US (2); DE (1); FI (1)