Naloxegol in Cancer Opioid-Induced Constipation

NCT02745353 | Terminated Phase 2 Results DMC

• 1 other identifier: 160121
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

Cancer; Constipation; Opioid

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks

Study Arms (2)

A

ACTIVE COMPARATOR

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.

Drug: naloxegol

B

ACTIVE COMPARATOR

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.

Drug: naloxegol

Interventions

naloxegol DRUG

Also known as: MOVANTIK

A; B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Joseph Ma: lead
• AstraZeneca: collaborator

Study Sites (1)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Constipation; Neoplasms

Interventions

naloxegol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Eric Roeland, MD
• Organization: UCSD

eroeland@ucsd.edu

(858) 534-7079

Study Officials

• Joseph Ma, PharmD

  UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Clinical Professor

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: April 20, 2016
• Study Start: May 1, 2016
• Primary Completion: June 22, 2017
• Study Completion: June 22, 2017
• Last Updated: December 9, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-12

Locations

US (1)