At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 41 enrolled
Drug / intervention
Anti-NGF ABbiological
Likely dose
Tanezumab 10 mg IV injection once every 8 weeksAI-extracted
Key inclusion· 3
- ✓Diagnosed cancer (prostate, breast, renal cell carcinoma, or multiple myeloma) with bone metastases
- ✓Previously randomized and treated with study drug in the parent double-blind trial (Study A4091003)
- ✓Karnofsky Performance Score ≥40%
Key exclusion· 2
- ✕Withdrawn from parent Study A4091003 due to adverse event or serious adverse event
- ✕Any adverse event or condition during or after parent study that, per investigator, increases safety risk or warrants exclusion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
PHASE 2 OPEN-LABEL SAFETY EXTENSION STUDY OF TANEZUMAB IN CANCER PATIENTS WITH PAIN DUE TO BONE METASTASES
In Brief
A Phase 2 clinical trial evaluating Anti-NGF AB for Neoplasms and Bone Metastases. Completed, enrolled 41 participants across 23 sites in 10 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Bone Metastases
CountriesAustria, Bosnia and Herzegovina, Croatia, Hungary, India, Latvia, Poland, Slovakia, South Korea, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 2009
Enrollment StartOct 2009
Primary CompletionFeb 2013
TodayJul 2026
First PostedJan 27, 2009
Enrollment StartOct 29, 2009
Primary CompletionFeb 14, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.4 years ago
Interventions
Anti-NGF ABbiological
Solution for injection, 10 mg, one injection/8 weeks