A Safety, Tolerability, And Pharmacokinetic Trial With CVX-241 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:
NCT01004822
First received: October 28, 2009
Last updated: May 3, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine if CVX-241 (PF-05057459) is safe and tolerable when given as weekly infusions to adult patients with advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors Epithelial Ovarian Cancer (EOC) or Primary Peritoneal Cancer (PPC) |
Drug: CVX-241 |
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: | A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, And Pharmacodynamic Study Of CVX-241, A Selective Angiopoietin-2 And Vascular Endothelial Growth Factor Binding, Anti-Angiogenic COVX-Body, In Patients With Advanced Solid Tumors |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Determine maximum tolerated dose of weekly infusions of CVX-241 (PF-05057459) in patients with advanced solid tumors [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Incidence of Dose Limiting Toxicities [DLTs], Adverse Events [AEs] and Serious Adverse Events [SAEs] [ Time Frame: Throughout duration of study ] [ Designated as safety issue: Yes ]
- Pharmacokinetic parameters of CVX-241 (AUC, Cmax, Cmin, Clearance, and T1/2) [ Time Frame: Days 1, 5, 8, 15, and 22 ] [ Designated as safety issue: No ]
- Change from baseline in serum Ang2 and plasma VEGF concentrations during and following CVX-241 therapy [ Time Frame: Baseline - Safety Follow-up ] [ Designated as safety issue: No ]
- Immunogenicity determined by measuring anti-CVX-241 antibodies following therapy [ Time Frame: Baseline - Safety Follow-Up ] [ Designated as safety issue: Yes ]
- Response rate (Stable Disease [SD], Partial Response [PR], Complete Response [CR]) by Response Evaluation Criterion In Solid Tumors [RECIST] and tumor response as determined by CA-125 in patients with EOC/PPC (stage 2). [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 5 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Active Drug
Weekly infusions of CVX-241 at specified doses
|
Drug: CVX-241
0.3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
Other Name: PF-05057459
Drug: CVX-241
1 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
Other Name: PF-05057459
Drug: CVX-241
3 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
Other Name: PF-05057459
Drug: CVX-241
6 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
Other Name: PF-05057459
Drug: CVX-241
12 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
Other Name: PF-05057459
Drug: CVX-241
15 mg/kg infusions of CVX-241 on Days 1, 8, 15, and 22 of each 28 day cycle. Weekly infusions administered until progression or unacceptable toxicity develops.
Other Name: PF-05057459
|
Detailed Description:
The study was prematurely discontinued on 14 September 2011 due to no significant pharmacological effects (safety/PD/efficacy) through 25 mg/kg cohort, the T1/2 based on VEGF binding was shorter than expected and the current and/or higher doses were not considered feasible for further development. There were no safety concerns associated with the decision to terminate the program/study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed solid tumors unresponsive to current therapy or for which there is no standard therapy.
- Stage 2 only: Histologically or cytologically documented EOC or PPC with < or equal to 3 previous anti-cancer therapies, but at least 1 prior platinum containing regimen.
- Adequate coagulation, liver, and renal function.
- Candidate for Dynamic Contrast-Enhanced Magnetic Resonance Imaging [DCE-MRI] evaluation
- Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1
Exclusion Criteria:
- History of clinically significant toxicity to Vascular Endothelial Growth Factor [VEGF] inhibition.
- Evidence of bleeding problems.
- Uncontrolled hypertension.
- Patients with primary brain cancer and/or non-small cell lung cancer of squamous cell histology
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004822
Locations
| United States, Arizona | |
| Pfizer Investigational Site | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, California | |
| Pfizer Investigational Site | |
| Santa Monica,, California, United States, 90404 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19111 | |
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: | NCT01004822 History of Changes |
| Other Study ID Numbers: | B1561001, CVX-241-101 |
| Study First Received: | October 28, 2009 |
| Last Updated: | May 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Treatment Non-Randomized Single Group Assignment Safety Study Neoplasms Carcinoma Cancer Malignancy |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms |
Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Neoplasms by Histologic Type Endothelial Growth Factors Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013