Study Of CP-751,871 In Combination With Sunitinib In Patients With 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:
NCT00729833
First received: July 30, 2008
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
The study is being conducted to determine the maximum tolerated dose, overall safety and tolerability profile, and pharmacokinetic profile of CP-751,871 and sunitinib when given in combination with advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Cancer Advanced Solid Tumors |
Drug: CP-751,871 Drug: Sunitinib |
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, Open Label, Sequential Cohort, Dose Escalation Study Of CP-751,871 In Combination With Sunitinib In Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- To determine the maximum tolerated dose (MTD) of CP-751,871 and sunitinib when given in combination in patients with advanced solid tumors [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the potential development of Anti-Drug Antibodies (ADA) in response to CP-751,871 [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
- To document evidence of antitumor activity in patients with measurable disease, of CP-751,871 when given in combination with sunitinib [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
- To characterize the PK of CP-751,871 and sunitinib (and its metabolite SU012662) when given in combination [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
- To define the overall safety and tolerability profile of CP-751,871 and sunitinib when given in combination [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
| Enrollment: | 45 |
| Study Start Date: | September 2008 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CP-751,871 + Sunitinib
Escalating cohorts of CP-751,871 + Sunitinib
|
Drug: CP-751,871
CP-751,871 IV, every 3 weeks
Drug: Sunitinib
Sunitinib - daily dosing
|
Detailed Description:
The study was closed to enrollment on 14 Jan 2011 and terminated secondary to excessive screen failure rate and for business reasons associated with Pfizer's business decision to stop development of the figitumumab compound. Safety concerns did not contribute to the decision to terminate this clinical trial.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically confirmed advanced solid tumors relapsed or refractory to standard therapy or for whom no standard therapy exists.
- ECOG Performance Status of 0 or 1;
- Total IGF-1 level ≥100 ng/ml;
- ECOG Performance Status of 0 or 1
- Adequate bone marrow, renal, and hepatic function
Exclusion Criteria:
- Concurrent treatment with any antitumor agents with the exception of LHRH agnosits for prostate cancer patients
- Treatment with any other investigational therapy within 4 weeks prior to study treatment
- Major surgery within 4 weeks of study treatment
- Prior treatment that may increase the risk of cardiac complications
- Ongoing cardiac dysrhythmias of NCI CTCAE Grade 2 or greater
- Significant active cardiac disease, including hypertension that cannot be controlled by medications
- Greater than three (3) prior lines of cytotoxic therapy;
- Active infection
- Prior IGF-IR targeted therapy;
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00729833
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Los Angeles, California, United States, 90095 | |
| Pfizer Investigational Site | |
| Santa Monica, California, United States, 90404 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
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: | NCT00729833 History of Changes |
| Other Study ID Numbers: | A4021024 |
| Study First Received: | July 30, 2008 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Sunitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013