Phase 2
Completed N=41
Open Label Extension In Cancer Patients
Neoplasms · bone metastases
Source: ClinicalTrials.gov NCT00830180 ↗
Enrolled (actual)
41
Serious AEs
56.1%
Results posted
Feb 2021
Primary outcomePrimary: Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 — -1.00; -1.17; -1.67; -1.88 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Parent Study (A4091003 [NCT00545129]) Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Score for at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 |
-1.00; -1.17; -1.67; -1.88; -1.33; -1.87 | — |
| PRIMARY Change From A4091029 Baseline in BPI-sf Average Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 |
-0.82; -0.69; -0.67; -1.19; -0.21; 0.00 | — |
| PRIMARY Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 |
-0.68; -0.72; -1.22; -1.24; -0.87; -0.87 | — |
| PRIMARY Change From Study A4091029 Baseline in BPI-sf Worst Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 |
-0.82; -0.48; -0.25; -1.14; -0.36; 0.00 | — |
| PRIMARY Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 |
-1.05; -1.28; -2.28; -2.18; -1.40; -2.60 | — |
| PRIMARY Change From Study A4091029 Baseline in BPI-sf Least Pain Score at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 |
-1.15; -1.00; -1.08; -1.81; -1.00; -1.00 | — |
| PRIMARY Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 |
-0.68; -1.61; -1.67; -2.24; -1.20; -2.40 | — |
| PRIMARY Change From Study A4091029 Baseline in BPI-sf Score for Right Now Pain at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 |
-0.82; -0.72; -0.67; -0.95; -0.21; -1.00 | — |
| PRIMARY Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) Weeks 4, 8, 16, 24, 40, 48, 56 and 64 |
-0.81; -1.10; -2.03; -1.26; -1.22; -1.61 | — |
| PRIMARY Change From Study A4091029 Baseline in BPI-sf Score for Pain Interference With Function (Composite Score) at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 |
-0.69; -0.79; -0.29; -0.88; -0.56; -1.71 | — |
| PRIMARY Change From Parent Study (A4091003 [NCT00545129]) Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 |
-0.68; -1.39; -1.94; -1.76; -1.47; -2.27 | — |
| PRIMARY Change From Study A4091029 Baseline in BPI-sf Item Scores for Pain Interference at Weeks 4, 8, 16, 24, 40, 48, 56 and 64 |
-0.85; -1.10; 0.04; -0.90; -0.57; -1.00 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00830180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.