Open Label Extension In Cancer Patients
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00830180
First received: January 26, 2009
Last updated: February 25, 2013
Last verified: February 2013
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Purpose
To evaluate the safety and efficacy of anti-NGF AB in cancer patients with pain due to bone metastases who participated in the double-blind Study A4091003 and who wish to receive open-label therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasms Bone Metastases |
Biological: Anti-NGF AB |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Open-Label Safety Extension Study Of Tanezumab In Cancer Patients With Pain Due To Bone Metastases |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Clinical laboratory tests [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
- Electrocardiograms [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
- Adverse events [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Brief Pain Inventory [ Time Frame: 9 months ] [ Designated as safety issue: No ]
| Enrollment: | 41 |
| Study Start Date: | October 2009 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Anti-NGF AB |
Biological: Anti-NGF AB
Solution for injection, 10 mg, one injection/8 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has been diagnosed as having metastasized to bone;
- Karnofsky Performance Score ≥40% at Baseline;
- patients randomized and treated with intravenous study drug in double-blind Study A4091003.
Exclusion Criteria:
- Patient was withdrawn from Study A4091003 for an adverse event or serious adverse event;
- Occurrence of any adverse event or condition during Study A4091003 or since termination from that study that, in the opinion of the Investigator, would put the patient at increased safety risk or should exclude the subject from participating in the open-label extension Study A4091029.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00830180
Locations
| United States, California | |
| Pfizer Investigational Site | |
| La Jolla, California, United States, 92037-7651 | |
| Pfizer Investigational Site | |
| La Jolla, California, United States, 92093 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Shreveport, Louisiana, United States, 71105 | |
| United States, Utah | |
| Pfizer Investigational Site | |
| Salt Lake City, Utah, United States, 84112-5550 | |
| Austria | |
| Pfizer Investigational Site | |
| Senftenberg, Austria, A-3541 | |
| Bosnia and Herzegovina | |
| Pfizer Investigational Site | |
| Banja Luka, Bosnia and Herzegovina, 78000 | |
| Croatia | |
| Pfizer Investigational Site | |
| Varazdin, Croatia, 42000 | |
| Hungary | |
| Pfizer Investigational Site | |
| Szekesfehervar, Hungary, 8003 | |
| India | |
| Pfizer Investigational Site | |
| Nagpur, Maharashtra, India, 440 010 | |
| Pfizer Investigational Site | |
| Nashik, Maharashtra, India, 422 005 | |
| Pfizer Investigational Site | |
| Lucknow, Uttar Pradesh, India, 226003 | |
| Korea, Republic of | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 120-752 | |
| Pfizer Investigational Site | |
| Seoul, Korea, Republic of, 135-710 | |
| Latvia | |
| Pfizer Investigational Site | |
| Riga, Latvia, LV 1079 | |
| Poland | |
| Pfizer Investigational Site | |
| Bydgoszcz, Poland, 85-796 | |
| Pfizer Investigational Site | |
| Gdansk, Poland, 80-208 | |
| Pfizer Investigational Site | |
| Wloclawek, Poland, 87-800 | |
| Slovakia | |
| Pfizer Investigational Site | |
| Banska Bystrica, Slovakia, 975 17 | |
| Pfizer Investigational Site | |
| Bratislava, Slovakia, 83310 | |
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: | NCT00830180 History of Changes |
| Other Study ID Numbers: | A4091029 |
| Study First Received: | January 26, 2009 |
| Last Updated: | February 25, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Cancer pain NGF open-label extension |
Additional relevant MeSH terms:
|
Neoplasms Neoplasm Metastasis Bone Neoplasms Bone Marrow Diseases Neoplastic Processes |
Pathologic Processes Neoplasms by Site Bone Diseases Musculoskeletal Diseases Hematologic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013