Figitumumab Combined With Pegvisomant For Advanced Solid Tumors
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00976508
First received: September 10, 2009
Last updated: November 8, 2012
Last verified: November 2012
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Purpose
This is a Phase 1 study investigating the safety and tolerability of Figitumumab plus Pegvisomant for treatment of advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Neoplasms Lung Neoplasms Breast Neoplasms Prostatic Neoplasms Sarcoma |
Drug: figitumumab Drug: pegvisomant |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1 Safety And Tolerability Study Of Figitumumab Combined With Pegvisomant In Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
MedlinePlus related topics:
Breast Cancer
Cancer
Colorectal Cancer
Lung Cancer
Prostate Cancer
Soft Tissue Sarcoma
Drug Information available for:
Pegvisomant
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To evaluate the safety and tolerability of figitumumab plus pegvisomant in patients with advanced solid tumors [ Time Frame: 4-Feb-2011 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the effect of combining pegvisomant with figitumumab on circulating concentrations of IGF I and other related biomarkers [ Time Frame: Jan 6, 2012 ] [ Designated as safety issue: No ]
- To evaluate the pharmacokinetics of figitumumab and pegvisomant and their relationships to changes in biomarkers [ Time Frame: Jan 6, 2012 ] [ Designated as safety issue: No ]
- To compare screening, cycle 1 day 8 and cycle 3 day 8 glucose tolerance [ Time Frame: Jan 6, 2012 ] [ Designated as safety issue: No ]
- To monitor any anti drug antibody (ADA) response to figitumumab [ Time Frame: Jan 6, 2012 ] [ Designated as safety issue: No ]
- To document any anti tumor activity of figitumumab plus pegvisomant [ Time Frame: Jan 6, 2012 ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | November 2009 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: figitumumab
IGF-1R antibody, 20 mg/kg, IV every 3 weeks for up to 1 year
Other Name: CP-751,871
Drug: pegvisomant
growth hormone antagonist, 10, 20 or 30 mg per day via subcutaneous injection for up to 1 year
Other Name: Somavert
|
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| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976508
Locations
| United States, Minnesota | |
| Pfizer Investigational Site | |
| Minneapolis, Minnesota, United States, 55455 | |
| Pfizer Investigational Site | |
| Rochester, Minnesota, United States, 55905 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Finland | |
| Pfizer Investigational Site | |
| Helsinki, Finland, 00290 | |
| Germany | |
| Pfizer Investigational Site | |
| Muenster, Germany, 48149 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00976508 History of Changes |
| Other Study ID Numbers: | A4021040 |
| Study First Received: | September 10, 2009 |
| Last Updated: | November 8, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
advanced solid tumors cancer refractory cancer figitumumab pegvisomant |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Colorectal Neoplasms Lung Neoplasms Prostatic Neoplasms Sarcoma Neoplasms by Site Breast Diseases Skin Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013