Back to resultsNaloxegol in Cancer Opioid-Induced Constipation
Primary Purpose
Constipation
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
naloxegol
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring Cancer, Constipation, Opioid
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
Sites / Locations
- UCSD Moores Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
A
B
Arm Description
Patients in Arm A will receive a single daily dose of 25mg naloxegol for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover treatment period in which the patient will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication.
Patients in Arm B will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover period in which the patient will receive a single daily dose of 25mg naloxegol.
Outcomes
Primary Outcome Measures
Number of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care
completion of treatment defined as participants receiving all single daily doses for 2 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT02745353
First Posted
April 15, 2016
Last Updated
December 5, 2019
Sponsor
Joseph Ma
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT02745353
Brief Title
Naloxegol in Cancer Opioid-Induced Constipation
Official Title
A Phase II, Randomized, Single Center, Pilot Feasibility Study to Evaluate Naloxegol for Opioid-Induced Constipation in Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Couldn't enough accrue patients
Study Start Date
May 2016 (Actual)
Primary Completion Date
June 22, 2017 (Actual)
Study Completion Date
June 22, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joseph Ma
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
Opioid-induced constipation (OIC) is a common symptom in patients with cancer-related pain and requires burdensome self-titration of laxatives for prophylaxis and treatment. Consequently, naloxegol may have an important role in this setting. Naloxegol has been evaluated in relieving OIC with cancer patients in a randomized, double blind, placebo-controlled trial over 4 weeks with a 12-week extension phase. However, accrual was challenging and the trial was closed early. Given the complexity of cancer and its treatment, a key first step is to determine if evaluating naloxegol versus standard of care is feasible in the management of OIC in this setting.
Subjects will receive naloxegol 25mg daily or usual care for a 2-week initial treatment period followed by 3-day washout period, then a 2-week crossover treatment period where subjects will receive naloxegol or usual care. Treatment assignment during the initial and crossover treatment periods will be dictated by the randomization arm. Subjects will also have the option to participate in a 12-week extension phase of naloxegol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Cancer, Constipation, Opioid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Patients in Arm A will receive a single daily dose of 25mg naloxegol for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover treatment period in which the patient will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication.
Arm Title
B
Arm Type
Active Comparator
Arm Description
Patients in Arm B will receive the treating physician's usual care for OIC using a stimulant laxative + rescue medication for the 2-week initial treatment period, followed by a 3-day washout period and 2-week crossover period in which the patient will receive a single daily dose of 25mg naloxegol.
Intervention Type
Drug
Intervention Name(s)
naloxegol
Other Intervention Name(s)
MOVANTIK
Primary Outcome Measure Information:
Title
Number of Participants That Completed Naloxegol 25mg and the Number of Participants That Completed Standard of Care
Description
completion of treatment defined as participants receiving all single daily doses for 2 weeks
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Ma, PharmD
Organizational Affiliation
UCSD
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Naloxegol in Cancer Opioid-Induced Constipation
We'll reach out to this number within 24 hrs