- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00976508
Figitumumab Combined With Pegvisomant For Advanced Solid Tumors
October 23, 2013 updated by: Pfizer
Phase 1 Safety And Tolerability Study Of Figitumumab Combined With Pegvisomant In Patients With Advanced Solid Tumors
This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.
Study Overview
Status
Terminated
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- Pfizer Investigational Site
-
-
-
-
-
Helsinki, Finland, 00290
- Pfizer Investigational Site
-
-
-
-
-
Muenster, Germany, 48149
- Pfizer Investigational Site
-
-
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- Pfizer Investigational Site
-
Rochester, Minnesota, United States, 55905
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year
Other Names:
growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: From Screening to the follow-up visit (90 days after last dose of figitimumab)
|
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)
Time Frame: From Cycle 2, Day 1 to Cycle 3, Day 8; from Cycle 1, Day 15 to end of Cycle 2
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Circulating Insulin-like Growth Factor (IGF-1) Levels
Time Frame: 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)
|
The effect of the combined therapy with figitumumab and pegvisomant on circulating concentrations of total IGF-1 was assessed.
|
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
Time Frame: Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15
|
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
Time Frame: 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 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
Time Frame: Cycle 1: Day 1 (within 2 hours before figitumumab infusion), Day 2 (1 hour post figitumumab infusion), Day 8 and Day 15
|
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
Time Frame: 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
|
Plasma Concentration at the Last Quantifiable Time Point (Clast) of Figitumumab from Cycle 2 to the end of treatment.
|
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
Time Frame: 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 plasma concentration time-curve from zero to the last measured concentration (AUClast) of figitumumab in cycle 1.
|
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
Time Frame: 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 plasma concentration time-curve from zero to the last measured concentration (AUClast)of figitumumab after Cycle 1
|
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)
Time Frame: 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
|
The trough concentration-time profile (AUCtrough) of pegvisomant was to be analyzed by noncompartmental methods.
|
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
Time Frame: Screening; Day 8 of Cycle 1; Day 15 of Cycle 2
|
The effect of combining figitumumab with pegvisomant was analyzed to assess whether pegvisomant reverses figitumumab-induced glucose intolerance at various pegvisomant dose levels.
The change in glucose load was assessed by Glucose Tolerance Testing (GTT) at baseline (fasting), during Cycle 1 following administration of figitumumab alone (post load), and near the end of Cycle 2 (post load) following combined therapy with figitumumab and pegvisomant.
|
Screening; Day 8 of Cycle 1; Day 15 of Cycle 2
|
Percentage of Participants Reporting Positive Anti-Drug Antibodies (ADA) Response for Figitumumab
Time Frame: 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)
|
Percentage of participants with positive total or neutralizing ADA 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
Time Frame: 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)
|
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST)version 1.1.
Confirmed CR defined as disappearance of all target lesions.
Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST version 1.1.
Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
September 10, 2009
First Submitted That Met QC Criteria
September 11, 2009
First Posted (Estimate)
September 14, 2009
Study Record Updates
Last Update Posted (Estimate)
December 13, 2013
Last Update Submitted That Met QC Criteria
October 23, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Genital Neoplasms, Male
- Breast Diseases
- Prostatic Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplasms
- Breast Neoplasms
- Prostatic Neoplasms
- Lung Neoplasms
- Colorectal Neoplasms
Other Study ID Numbers
- A4021040
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sarcoma
-
Albert Einstein College of MedicineNational Cancer Institute (NCI)TerminatedUterine Corpus Leiomyosarcoma | Stage IIA Uterine Sarcoma | Stage IIB Uterine Sarcoma | Stage IIIA Uterine Sarcoma | Stage IIIB Uterine Sarcoma | Stage IIIC Uterine Sarcoma | Stage IVA Uterine Sarcoma | Stage IVB Uterine Sarcoma | Stage IA Uterine Sarcoma | Stage IB Uterine Sarcoma | Stage IC Uterine SarcomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedBone Sarcoma | Retroperitoneal Sarcoma | Adult Soft Tissue SarcomaUnited States
-
Mohammed M MilhemGenentech, Inc.CompletedSarcoma | Soft Tissue Sarcoma | Metastatic Sarcoma | Locally Advanced Sarcoma | Unresectable SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
-
National Cancer Institute (NCI)RecruitingMetastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Metastatic Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Unresectable SarcomaUnited States
-
National Cancer Institute (NCI)CompletedRhabdomyosarcoma | Synovial Sarcoma | Ewing's Sarcoma | MPNST | High-risk SarcomaUnited States
-
Epizyme, Inc.RecruitingAdvanced Soft-tissue Sarcoma | Advanced Epithelioid SarcomaUnited States, Taiwan, Canada, United Kingdom
-
Brown UniversityActuate Therapeutics Inc.WithdrawnSoft Tissue Sarcoma | Osteosarcoma | Ewing Sarcoma of Bone | Leiomyosarcoma | High Grade Sarcoma | Liposarcoma | Rhabdomyosarcoma | Angiosarcoma | Bone Sarcoma | Synovial Sarcoma | Undifferentiated Pleomorphic Sarcoma | Myxofibrosarcoma | Spindle Cell SarcomaUnited States
-
David DickensWithdrawnSoft Tissue Sarcoma | Bone Sarcoma | Unresectable Soft Tissue Sarcoma | Metastatic Soft-tissue Sarcoma | Metastatic Bone Sarcoma | Unresectable Bone SarcomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
Clinical Trials on figitumumab
-
PfizerNational Cancer Institute (NCI)Withdrawn
-
PfizerTerminatedCarcinoma, Non-Small-Cell Lung | Carcinoma, Squamous Cell | Carcinoma, Large Cell | Carcinoma, Adenosquamous CellUnited States, Bulgaria, Italy, Spain, Ukraine, Belgium, France, Ireland, Korea, Republic of, Poland, Russian Federation, United Kingdom, Hungary, Serbia, Taiwan, Canada, South Africa, Brazil, Romania, Greece, Puerto Rico, Czech Republic and more
-
PfizerTerminatedCarcinoma, Non-Small-Cell Lung | Carcinoma, Squamous Cell | Carcinoma, Adenosquamous | Carcinoma, Large CellUnited States, Bulgaria, Canada, Ukraine, Greece, Austria, France, Korea, Republic of, Poland, Russian Federation, Spain, Turkey, Finland, Hungary, Taiwan, Italy, Japan, Australia, Germany, Brazil, India, Puerto Rico, Czech Republic, ... and more
-
PfizerTerminatedSmall Cell Lung CarcinomaUnited States, Spain, Canada, Hungary