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ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neoplasms, Bone Metastases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Patient was withdrawn from Study A4091003 for an adverse event or serious adverse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.
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Neoplasms, Bone MetastasesOpen Label Extension In Cancer Patients
NCT00830180
- La Jolla, California
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- La Jolla, California
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- Shreveport, Louisiana
- Salt Lake City, Utah
- Senftenberg,
- Banja Luka,
- Varazdin,
- Szekesfehervar,
- Nagpur, Maharashtra
- Nashik, Maharashtra
- Lucknow, Uttar Pradesh
- Seodaemun-gu, Seoul
- Seoul,
- Riga,
- Bydgoszcz,
- Gdansk,
- Poznan,
- Poznan,
- Wloclawek,
- Banska Bystrica,
- Bratislava,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Open Label Extension In Cancer Patients | ||||||
| Official Title ICMJE | PHASE 2 OPEN-LABEL SAFETY EXTENSION STUDY OF TANEZUMAB IN CANCER PATIENTS WITH PAIN DUE TO BONE METASTASES | ||||||
| Brief Summary | 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. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Allocation: Non-Randomized Masking: None (Open Label) Primary Purpose: Treatment | ||||||
| Condition ICMJE |
| ||||||
| Intervention ICMJE | Biological: Anti-NGF AB
Solution for injection, 10 mg, one injection/8 weeks | ||||||
| Study Arms ICMJE | Experimental: Anti-NGF AB
Intervention: Biological: Anti-NGF AB | ||||||
| Publications * | Sopata M, Katz N, Carey W, Smith MD, Keller D, Verburg KM, West CR, Wolfram G, Brown MT. Efficacy and safety of tanezumab in the treatment of pain from bone metastases. Pain. 2015 Sep;156(9):1703-1713. doi: 10.1097/j.pain.0000000000000211. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 41 | ||||||
| Original Estimated Enrollment ICMJE | 100 | ||||||
| Actual Study Completion Date ICMJE | February 14, 2013 | ||||||
| Actual Primary Completion Date | February 14, 2013 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Austria, Bosnia and Herzegovina, Croatia, Hungary, India, Korea, Republic of, Latvia, Poland, Slovakia, United States | ||||||
| Removed Location Countries | France, Hong Kong, Peru | ||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00830180 | ||||||
| Other Study ID Numbers ICMJE | A4091029 2008-005182-66 ( EudraCT Number ) CANCER PAIN OL EXTENSION ( Other Identifier: Alias Study Number ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | February 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||