An Open-Label Study Investigating Long-Term Safety and Tolerability of Nasalfent (Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy

Phase 3

• Conditions: Break ThroughCancer Pain; 10027656

• Registration Number: NL-OMON30752
• Lead Sponsor: I3Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

Subjects will be included in the study if they meet all of the following criteria:
1. Subjects who are able and willing to provide written informed consent.
2. Male or female subjects, 18 years of age and older.
3. If female, and of childbearing potential (not surgically sterile or <=1 year after the onset of amenorrhea due to menopause), must (a) have a negative serum pregnancy test, (b) not be lactating, and (c) agree to practice a reliable form of contraception or abstinence during the study.
4. Subjects who have a histologically documented diagnosis of a malignant solid tumor or a hematological malignancy causing cancer-related pain.
5. Subjects who are taking at least 60 mg oral morphine or equivalent for at least 1 week for cancer-related pain as regular, 24-hour medication for their underlying persistent cancer pain.
6. Subjects who are experiencing, on average, but not necessarily every day, 1 to 4 episodes of BTCP per day that are adequately controlled with a stable dose of standard rescue medication, typically a fast-acting opioid, of which the subject should have an adequate supply throughout the study. Breakthrough pain is defined as a transitory flare of moderate to severe pain (on a 4 point scale from 0 to 3; none, mild, moderate, severe) that occurs on a background of persistent pain controlled to moderate intensity or less (as defined by the Breakthrough Pain Questionnaire) by the opioid regimen. If the subject has more than 1 type of breakthrough pain, or has breakthrough pain in more than 1 location, only 1 of the pains will be identified as a *target* breakthrough pain.
7. Subjects who, in the opinion of the investigator, are willing and able (personally or with the help of a caregiver) to
a. Evaluate and record pain intensity and pain relief.
b. Assess medication performance at specific times after dosing.
c. Record adverse events.
d. Record each instance of the use of study drug, standard rescue medication, and other medications in a subject diary for the duration of the study.
8. Subjects with an Eastern Cooperative Oncology Group (ECOG) score of <=2 and a life expectancy which, in the opinion of the investigator, will allow them to participate for the duration of the study.

Exclusion Criteria

Subjects may be excluded from participating in the study if they meet any of the following criteria:
1. Subjects with an opioid or fentanyl intolerance.
2. Subjects with uncontrolled or rapidly escalating pain.
3. Subjects using intrathecal or epidural opioids.
4. Subjects whose condition is unstable or rapidly deteriorating that the effective dose found during the Open, Dose-Titration Phase is unlikely to remain so for the duration of the study.
5. Subjects with sleep apnea or active brain metastases with increased intracranial pressures.
6. Subjects with any respiratory or cardiac condition that, in the opinion of the investigator, may be worsened by opioids.
7. Subjects with any other medical condition that, in the judgment of the investigator, would confound the objectives of the study.
8. Subjects with a recent history of alcohol or substance abuse that would compromise data collection.
9. Subjects with a history of or current neurological or psychiatric impairment, or cognitive dysfunction that, in the opinion of the investigator, would compromise data collection.
10. Subjects with clinically significant renal and hepatic dysfunction test results at Screening outside the following limits:
a. Serum creatinine must be <=2.0 mg/dL, or creatinine clearance calculated by Cockcroft-Gault formula must be >=50 mL/min.
b. Serum total bilirubin must be <=2.0 mg/dL.
c. Serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase must be <=3 times the upper limit of normal (<=5 times the upper limit of normal if due to liver metastases).
11. Subjects taking any medication likely to affect the physiology of the nasal mucosa.
12. Any abnormal nasal physiology and/or pathology which, in the opinion of the investigator, would not allow the objectives of the study to be accomplished.
13. Subjects with known intolerance to nasal sprays and/or pharmaceutical materials found in the investigational products.
14. Subjects taking monoamine oxidase inhibitors (MAOIs) within 14 days of the screening visit or with an anticipated need for MAOIs during the study.
15. Subjects taking analgesics (other than that taken for underlying persistent cancer pain) for less than 21 days prior to the screening visit, even at a stable dose.
16. Subjects receiving antiepileptics for neuropathic pain (such as gabapentin, topiramate, lamotrigine) that is not the target breakthrough pain for less than 14 days prior to screening.
17. Subjects with uncontrolled infection.
18. Subjects who have received treatment with an investigational drug within 4 weeks of the screening visit.
19. Subjects who have had treatment with any form of radiotherapy within 30 days prior to study entry or who have had any therapy that could alter pain or response to pain medication.
20. Subjects planning to undergo chemotherapy (unless it has been demonstrated in that subject to have no effect on the breakthrough cancer pain), radiotherapy, or surgery during the treatment period.
21. Subjects whose primary source of breakthrough pain is not cancer related.

Study & Design

• Study Type: Interventional
• Study Design: Not specified