Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2021
• Main ID: NCT02609828
• Date of registration: 26/10/2015
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Phase 3 Study on the Efficacy and Safety of Tanezumab in Patients With Cancer Pain Due to Bone Metastasis Who Are Taking Background Opioid Therapy
• Scientific title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB (PF-04383119) IN SUBJECTS WITH CANCER PAIN PREDOMINANTLY DUE TO BONE METASTASIS RECEIVING BACKGROUND OPIOID THERAPY
• Date of first enrolment: October 28, 2015
• Target sample size: 156
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02609828
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Argentina, Australia, Austria, Brazil, Chile, China, Czech Republic, Czechia, France, Germany, Hungary, Israel, Japan, Korea, Republic of, Poland, Romania, Slovakia, Spain, United Kingdom

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Personally signed and dated informed consent document.

- Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study procedures.

- Male or female, =18 years of age

- Weight =40 kg at Screening

- Cancer diagnosed as having metastasized to bone or multiple myeloma.

- Imaging confirmation of bone metastasis at Screening or within 120 days prior to the
Screening visit.

- Expected to require daily opioid medication throughout the course of the study.

- Willing to not use prohibited medications (including NSAIDs) throughout the duration
of the study.

- Average Pain Score =5 at Screening for the index bone metastasis cancer pain site.

- Patient's Global Assessment of Cancer Pain of "fair", "poor" or "very poor" at
Screening.

- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1, or 2 at
Screening.

- Adequate bone marrow, renal and liver function at Screening.

- International Normalized Ratio (INR) or prothrombin time (PT) <1.5 x ULN at Screening
unless being treated with anticoagulant medication.

- Females must either be not of childbearing potential or, if of childbearing potential
and at risk for pregnancy, must be willing to use at least one highly effective method
of contraception throughout the study and for 112 days (16 weeks) after the last dose
of assigned subcutaneous study medication.

Exclusion Criteria:

- Pain related to an oncologic emergency.

- Brain metastasis or leptomeningeal metastasis.

- Presence of hypercalcemia at Screening.

- Pain primarily classified as not predominantly related to a bone metastasis.

- Systemic treatment for the primary malignancy or bone metastasis started within 30
days of the Baseline Assessment Period.

- Chemotherapies associated with peripheral neuropathy (ie, paclitaxel, docetaxel,
oxaliplatin, cisplatin, vincristine, thalidomide or bortezomib) are prohibited during
the study from 30 days prior to the first day of the Baseline Assessment Period to
Week 48.

- Receipt of radiopharmaceutical treatment or radiotherapy for treatment of bone
metastasis within 30 days of the Baseline Assessment Period.

- Concurrent adjuvant analgesics unless started at least 30 days prior to the start of
the Baseline Assessment Period and maintained at a stable dose.

- Diagnosis of osteoarthritis of the knee or hip or findings consistent with
osteoarthritis in the shoulder.

- History of significant trauma or surgery to a major joint within one year prior to
Screening.

- History of osteonecrosis or osteoporotic fracture.

- X-ray evidence at Screening of: 1) rapidly progressive osteoarthritis, 2) atrophic or
hypotrophic osteoarthritis, 3) subchondral insufficiency fracture, 4) spontaneous
osteonecrosis of the knee (SPONK), 5) osteonecrosis, or 6) pathologic fracture.

- Signs and symptoms of clinically significant cardiac disease.

- Evidence of orthostatic hypotension at Screening or at Baseline prior to
randomization.

- Diagnosis of a transient ischemic attack in the 6 months prior to Screening or
diagnosis of stroke with significant residual deficits.

- History, diagnosis, or signs and symptoms of clinically significant neurological
disease.

- Total impact score of >7 on the Survey of Autonomic Symptoms (SAS) at Screening.

- Past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one
year prior to Screening.

- History of significant alcohol, analgesic, or narcotic substance abuse within the six
months prior to Screening.

- Planned surgical procedure during the duration of the study.

- Considered unfit for surgery or not willing to undergo joint replacement surgery if
required.

- Known hypersensitivity to opioids or an underlying medical condition contraindicating
opioid use.

- History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal
antibody or IgG-fusion protein.

- Previous exposure to exogenous nerve growth factor or to an anti-nerve growth factor
antibody.

- Presence of drugs of abuse, prescription medications without a valid prescription or
other illegal drugs at Screening.

- Positive Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) tests at
Screening indicative of current infection.

- Investigational site staff members and their family members, or Pfizer employees
directly involved in the conduct of the trial.

- Participation in other studies involving investigational drug(s) within 30 days (or 90
days for investigational biologics) before Baseline Assessment Period and/or during
study participation.

- Pregnant female subjects; breastfeeding female subjects; female subjects of
childbearing potential who are unwilling or unable to use one (1) highly effective
method of contraception throughout the study and for 112 days after last dose of
investigational product.

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Bone Metastasis

Cancer Pain

Intervention(s)

Drug: Tanezumab

Primary Outcome(s)

Change from baseline in daily average pain intensity in index bone metastasis cancer pain site [Time Frame: 8 weeks]

Secondary Outcome(s)

Change from baseline in daily worst pain intensity in index bone metastasis cancer pain site [Time Frame: Up to 24 weeks]

Orthostatic (supine/standing) blood pressure assessment [Time Frame: Up to 48 weeks]

Response as defined by a 30%, 50%, 70%, and 90% reduction from Baseline in the daily average and daily worst pain intensity NRS score in the index bone metastasis cancer pain site [Time Frame: Up to 24 weeks]

Total joint replacements [Time Frame: Up to 24 weeks post-procedure]

Weight and Height measurements, Physical examinations. [Time Frame: Up to 48 weeks]

Adverse events [Time Frame: Up to 48 weeks]

Average number of doses of rescue medication required per week [Time Frame: Up to 24 weeks]

Change from baseline in daily average pain intensity in non-index visceral cancer pain sites [Time Frame: Up to 24 weeks]

Change from baseline in Patient's Global Assessment of Cancer Pain [Time Frame: Up to 24 weeks]

Change from baseline in the BPI Pain Interference with Function composite score and individual pain interference item scores [Time Frame: Up to 24 weeks]

Change from baseline in daily average pain intensity in index bone metastasis cancer pain site [Time Frame: Up to 24 weeks]

EuroQol 5 Dimension (EQ-5D-5L) dimensions and overall health utility score [Time Frame: Up to 24 weeks]

Neurologic examination (Neuropathy Impairment Score [NIS]). [Time Frame: Up to 48 weeks]

Average daily total opioid consumption (in mg of morphine equivalent doses) [Time Frame: Up to 24 weeks]

Change from baseline in daily worst pain intensity in non-index visceral cancer pain sites [Time Frame: Up to 24 weeks]

Change from baseline in weekly average pain intensity in non-index cancer pain sites [Time Frame: Up to 24 weeks]

Change from baseline in weekly Opioid-Related Symptom Distress Scale [Time Frame: Up to 24 weeks]

Joint safety adjudication outcomes [Time Frame: Up to 48 weeks, or up to 24 weeks following total joint replacement procedure]

Change from baseline in BPI worst pain score [Time Frame: Up to 24 weeks]

Change from baseline in weekly worst pain intensity in non-index cancer pain sites [Time Frame: Up to 24 weeks]

Response defined as an improvement of 2 points in Patient's Global Assessment of Cancer Pain [Time Frame: Up to 24 weeks]

Standard safety assessments [Time Frame: Up to 48 weeks]

Anti-drug antibody (ADA) assessments [Time Frame: Up to 48 weeks]

Change from baseline in Brief Pain Inventory (BPI) average pain score [Time Frame: Up to 24 weeks]

Survey of Autonomic Symptom scores [Time Frame: Up to 48 weeks]

Secondary ID(s)

CANCER PAIN PH 3 SC STUDY

2013-002223-42

A4091061

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eli Lilly and Company