A Study Of RN624 (PF-04383119) And Oxycodone In Patients With Pain Due To Cancer That Has Spread To Bone

Condition(s) targeted: Palliative Care; Neoplasm Metastasis

Intervention: PF-04383119 (RN624) + Oxycodone IR (Drug); Oxycodone IR (Drug); PF-04383119 (RN624) (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

The purpose of this study is to investigate whether RN624 (alone and in combination with oxycodone) is safe and effective in treating pain due to cancer that has spread to bone.

Official title: Phase II Randomized, Double Blind, Active Controlled Multicenter Proof Of Concept Efficacy And Safety Study Of RN624 (PF 04383119) Alone Or Combined With Oxycodone Vs Oxycodone In Patients With Pain Due To Bone Metastases

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from Baseline to Week 6 in daily average pain intensity measured by the 11 point Pain Intensity Numerical Rating Scale (NRS; 0-10). Baseline is the average daily Pain NRS score during Stabilization Phase prior to Randomization (3 days).

Secondary outcome:

Change from Baseline to Weeks 1, 2, 4, 6, 8 and 12, in the modified Brief Pain Inventory (mBPI) average pain scores obtained at study visits.

Response as defined by a ≥50% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days).

Response as defined by a ≥30% reduction from Baseline in the daily average pain intensity NRS score at Weeks 1, 2, 4, 6, 8, and 12.

Response as defined by a ≥50% reduction from Baseline in the daily average pain intensity NRS score at Weeks 1, 2, 4, 6, 8, and 12.

Total duration of response as defined by days with ≥30% reduction from Baseline in the daily average pain intensity NRS score.

Total duration of response as defined by days with ≥50% reduction from Baseline in the daily average pain intensity NRS score.

Human Anti Human Antibody testing at Baseline and Weeks 4, 8, 12 and 16 (or at early termination).

Change from Baseline to Weeks 1, 2, 4, 6, 8 and 12, in the mBPI worst pain scores obtained at study visits.

Change in the weekly Opioid Related Symptom Distress Scale at Weeks 1, 2, 3, 4, 6, 8, 10, and 12

Change from Baseline to Weeks 1, 2, 4, 6, 8, and 12, in the mBPI Pain Interference with Function Composite Score and individual pain interference item scores obtained at study visits.

Change from Baseline to Weeks 5-12 and 5-8 in the daily worst pain intensity NRS score.

Patient's Global Evaluation of Study Medication at Weeks 1, 2, 4, 6, 8, and 12.

Average number of doses of rescue medication required per week (up to Week 12).

Clinical laboratory assessments (hematology, blood chemistry, PT/PTT, urinalysis) at Screening, Baseline, and Weeks 2, 4, 8, 12 and 16 (or at early termination).

Adverse events from time of first dose of study treatment through the last patient visit.

Physical examination at Screening, Week 8 and Week 16 (or at early termination).

Weight measurements at Screening, Week 8 and Week 16 (or at early termination).

Change from Baseline to Weeks 5-12 and 5-8 in the daily average pain intensity NRS score.

Time to a ≥30% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days).

Response as defined by a ≥30% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days).

Average daily opioid consumption (up to Week 12).

ECG at Baseline (predosing and 1 hr post-dose) and Weeks 4, and 16 (or at early termination).

Change from Baseline to Weeks 1, 2, 4, 8 and 12 in the daily average pain intensity NRS score.

Change from Baseline to Weeks 1, 2, 4, 6, 8 and 12 in the daily worst pain intensity NRS score.

Vital sign measurements at Screening, Baseline, and Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16 (or at early termination).

Time to a ≥50% reduction from Baseline in the daily average pain intensity NRS score (sustained for a minimum of 4 consecutive days).

Change in Patient's Global Assessment of Disease (Cancer Pain) Activity at Weeks 1, 2, 4, 6, 8 and 12.

Neurologic examination at Screening, Baseline, and Weeks 1, 2, 3, 4, 6, 8, 10, 12, and 16 (or at early termination).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Prostate cancer or breast cancer that has spread to bone, causing moderate to severe

bone pain.

- Patients are either taking low dose opioid medication for pain control, or are not

taking any opioids but need to start taking opioids.

Exclusion Criteria:

- Patients who do not have bone pain caused by cancer are not eligible for the study.

- Patients who started chemotherapy less than 8 weeks ago, or who completed radiotherapy

less than 12 weeks ago, are not eligible.

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, BIRMINGHAM, Alabama 35233, United States; Not yet recruiting

Pfizer Investigational Site, Birmingham, Alabama 35233, United States; Not yet recruiting

Pfizer Investigational Site, Litchfield Park, Arizona 85340, United States; Not yet recruiting

Pfizer Investigational Site, Sun City, Arizona 85351, United States; Not yet recruiting

Pfizer Investigational Site, Antioch, California 94509, United States; Not yet recruiting

Pfizer Investigational Site, Concord, California 94520, United States; Not yet recruiting

Pfizer Investigational Site, San Leandro, California 94578, United States; Not yet recruiting

Pfizer Investigational Site, Walnut Creek, California 94598, United States; Not yet recruiting

Pfizer Investigational Site, Hackensack, New Jersey 07601, United States; Recruiting

Pfizer Investigational Site, Teaneck, New Jersey 07666, United States; Recruiting

Pfizer Investigational Site, Middletown, Ohio 45042, United States; Not yet recruiting

Pfizer Investigational Site, Myrtle Beach, South Carolina 29572, United States; Not yet recruiting

Pfizer Investigational Site, Beaumont, Texas 77701, United States; Not yet recruiting

Pfizer Investigational Site, Ogden, Utah 84403-3274, United States; Not yet recruiting

To obtain contact information for a study center near you, click here.

Starting date: October 2008
Ending date: July 2010
Last updated: June 12, 2008