Naloxegol in Cancer Opioid-Induced Constipation
Condition: Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: naloxegol
Intervention MeSH terms: Naloxegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer; Constipation; Opioid

Summary:

      The purpose of this study is to compare the effect of naloxegol versus the patient's usual
      care in treating opioid-induced constipation, as well as the effect on the patient's quality
      of life and how much pain is experienced. Also, the purpose of this study is to compare
      whether treatment with naloxegol versus usual care has any impact on the number of hospital
      or clinic visits or telephone calls to the patient's physician that are related to
      constipation, and to determine the patient's preference for continuing to receive naloxegol
      as treatment for opioid-induced constipation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults greater than or equal to 18 years old.

          -  Eastern Cooperative Oncology Group (ECOG) less than or equal to 3.

          -  Glomerular filtration rate (GFR) greater than or equal to 30 ml/min/1.73m2 by
             Modification of Diet in Renal Disease (MDRD).

          -  Corrected serum calcium level less than or equal to 10.5 mg/dL.

          -  Estimated life expectancy greater than or equal to 6 months.

          -  Negative pregnancy test prior to initiating study treatment for females of
             childbearing potential.

        Exclusion Criteria:

          -  Patients receiving the following medications within 3 days of Study Day 1 and/or are
             planned to receive throughout the duration of the study period: opioid antagonist,
             mixed antagonist, a strong CYP3A4 and/or P-glycoprotein (P-gp) inhibitor, a moderate
             CYP3A4 and/or P-gp inhibitor, and/or a strong CYP3A4 inducer.

          -  Concurrent total parenteral nutrition and/or use of metoclopramide.

          -  Patients at high risk for bowel perforation.

          -  Constipation that was not primarily caused by opioids in the investigator's medical
             opinion.

          -  A condition that may have affected the permeability of the blood-brain barrier (e.g.,
             known brain metastases, meningeal metastases, brain injury, multiple sclerosis, recent
             brain injury, uncontrolled epilepsy)

          -  Patient has clinically active diverticular disease.

          -  Past medical history of irritable bowel syndrome, signs of active gastrointestinal
             (GI) bleeding, acute surgical abdomen, bowel stents, indwelling peritoneal catheter,
             mechanical GI obstruction, fecal impaction, or fecal ostomy.

          -  Patient has motility/neurologic disorders including autonomic failure (spinal cord
             lesions, tumor invasion of nerves) and/or poorly controlled endocrine/metabolic
             disorders (hypercalcemia, hypokalemia, diabetes, hypothyroidism), as determined by the
             investigator.

          -  Uncontrolled cancer pain despite analgesic therapy