Phase 2 Study of Tanezumab in Subjects With Moderate to Severe Pain Due to Schwannomatosis (NCT04163419) | Clinical Trial Compass
UnknownPhase 2
Phase 2 Study of Tanezumab in Subjects With Moderate to Severe Pain Due to Schwannomatosis
United States9 participantsStarted 2020-04-30
Plain-language summary
The primary objective of this study is to determine whether the administration of tanezumab, an anti-nerve growth factor (NGF) antibody, improves pain relief in schwannomatosis patients receiving background non-NSAID therapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients must have a confirmed diagnosis schwannomatosis by fulfilling either clinical or molecular diagnosis.
✓. Age ≥ 18 years. Patients \< 18 years are excluded since the safety profile of tanezumab in this population has not been determined.
✓. ECOG performance status ≤2 or Karnofsky ≥60%
✓. Participants must have normal organ and marrow function as defined per the full protocol
✓. The subject's weight must be≥ 45 kg at Screening.
✓. The subject must be willing to avoid prohibited pain medications (including non-steroidal anti-inflammatory drugs) throughout the duration of the study except as permitted per Protocol.
✓. Subject must have moderate to severe pain secondary to schwannomatosis, defined as Score ≥5 on the Numeric Rating Scale-11 (NRS-11) at Screening.
✓. Subject must have failure, intolerance, or contraindication to at least three standard of care therapies:
Exclusion criteria
✕. Subjects with any of the following criteria: evidence of bilateral vestibular schwannomas on imaging, a known germline pathogenic NF2 mutation, a first-degree relative who meets diagnostic criteria for NF2, or have schwannomas limited to a previous radiation field.
✕. Subjects with intracranial meningioma associated with cerebral edema on neuroimaging. Note: presence of intracranial meningioma itself is not an exclusion criterion.
. Subjects who have had surgery, chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) for treatment of a painful schwannomatosis-related tumor prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
✕. Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days (or 90 days for biologics) before Screening and/or during study participation.
✕. Subjects receiving anticoagulation to treat an underlying medical condition.
✕. Subject has a history of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG fusion protein.
✕. The subject's pain is related to a non-schwannomatosis cause such as prior cancer therapy, infection, bowel obstruction/perforation, spinal cord compression, or fracture or impending fracture of weight bearing bone.
✕. The subject has a diagnosis of malignancy in the last 3 years (except for Gleason 6 prostate cancer, basal cell carcinoma or carcinoma in situ).