NCT00545129|CompletedPhase 2ResultsDMC

A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone

PHASE II RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER EFFICACY AND SAFETY STUDY OF TANEZUMAB AS ADD-ON THERAPY TO OPIOID MEDICATION IN PATIENTS WITH PAIN DUE TO BONE METASTASES

Pfizer ClinicalTrials.gov

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3 other identifiers

A40910032008-005181-31CANCER PAIN POC

Study Type

interventional

Target

Locations

13 countries

Sites

Timeline

RegisteredOct 2007

StartedApr 2009

CompletionFeb 2012

Brief Summary

The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Apr 2009

Typical duration for phase_2

Geographic Reach

13 countries

39 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.8 years study duration

First Submitted

Initial submission to the registry

October 15, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2007

Completed

1.5 years until next milestone

Study Start

First participant enrolled

April 29, 2009

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2011

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2012

Completed

9.4 years until next milestone

Results Posted

Study results publicly available

June 18, 2021

Completed

Last Updated

June 18, 2021

Status Verified

May 1, 2021

Enrollment Period

2.7 years

First QC Date

October 15, 2007

Results QC Date

May 24, 2021

Last Update Submit

May 24, 2021

Conditions

Neoplasm Metastasis Palliative Care

Outcome Measures

Primary Outcomes (1)

Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Week 6
Daily average pain was assessed on an 11-point NRS over the past 24 hours (before each specified visit), where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". Lower the score, lesser the pain intensity.
Baseline, Week 6

Secondary Outcomes (31)

Change From Baseline in Daily Average Pain Intensity Numeric Rating Scale (NRS) Score at Weeks 1, 2, 4, 8, 12 and 16
Baseline, Weeks 1, 2, 4, 8, 12, 16
Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Baseline Observation Carried Forward (BOCF)
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Change From Baseline in Daily Worst Pain Intensity Numeric Rating Scale (NRS) Score at Week 1, 2, 4, 6, 8, 12 and 16: Last Observation Carried Forward (LOCF)
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: BOCF
Baseline, Week 1, 2, 4, 6, 8, 12, 16
Change From Baseline in Brief Pain Inventory-Short Form (BPI-sf) Average Pain Scores at Week 1, 2, 4, 6, 8, 12 and 16: LOCF
Baseline, Week 1, 2, 4, 6, 8, 12, 16
+26 more secondary outcomes

Study Arms (2)

Tanezumab 10 mg IV + opioids

EXPERIMENTAL

Drug: Tanezumab 10 mg IV

Placebo + opioids

PLACEBO COMPARATOR

Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.

Drug: IV Placebo for tanezumab

Interventions

Tanezumab 10 mg IVDRUG

Single IV infusion of 10 mg tanezumab on Day 1. Maintained on baseline opioid regimen.

Tanezumab 10 mg IV + opioids

IV Placebo for tanezumabDRUG

Single IV infusion of placebo for tanezumab on Day 1. Maintained on baseline opioid regimen.

Placebo + opioids

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Prostate cancer, breast cancer, renal cell carcinoma or multiple myeloma that has spread to bone, causing moderate to severe bone pain.
Requires daily opioid medication

You may not qualify if:

Patients who do not have bone pain caused by cancer are not eligible for the study.
Patients who started chemotherapy less than 4 weeks ago, or who completed radiotherapy less than 4 weeks ago, are not eligible.
Known history or evidence of osteoarthritis. History of significant trauma to a major joint within 1 year prior to Screening.
Known history of rheumatoid arthritis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Pfizerlead

Study Sites (39)

UCSD Center for Pain Medicine

La Jolla, California, 92037-7651, United States

Location

UCSD Medical Center - Thornton Hospital

La Jolla, California, 92037-7651, United States

Location

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

Indiana Pain and Spine Clinic

South Bend, Indiana, 46617, United States

Location

WK River Cities Clinical Research Center

Shreveport, Louisiana, 71105, United States

Location

Willis Knighton Pierremont Health Center

Shreveport, Louisiana, 71115, United States

Location

Hollings Cancer Center