Pilot of Osanetant to Reduce Severity of Hot Flashes in Men With Adenocarcinoma of the Prostate

NCT ID: NCT05647447

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-03
• Study Completion Date: 2023-10-05

Brief Summary

To evaluate the preliminary efficacy of in reducing the frequency and severity of hot flashes in men on androgen deprivation therapy (ADT).

Conditions

Prostate Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pilot Trial: Osanetant 28 Days

Osanetant 200 mg orally, twice per day for 28 days.

Group Type: EXPERIMENTAL

Osanetant

Intervention Type: DRUG

Osanetant 200 mg orally, twice per day

Interventions

Osanetant

Osanetant 200 mg orally, twice per day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
• Males ≥ 18 years
• Histologic diagnosis of prostate cancer (PCa)
• Undergoing active treatment with ADT within ≥ 30 days prior to randomization
• Using either an gonadotropin releasing hormone (GNRH) agonist with a planned duration covering the 8 weeks of the study or are status post bilateral orchiectomy,
• Have a castrate level of testosterone (≤ 50 ng/dL) at enrollment
• Have moderate-to-severe hot flashes defined as

• Seven (7) or more hot flashes per day
• Total hot flash severity (HFS: total number of hot flashes for 1 week multiplied by the average severity/week) ≥ 100
• Adequate organ function, defined as follows: Result Date

• Leukocytes > 1.5K/UL
• Absolute Neutrophil Count (ANC) >1.5K/UL NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 if in the opinion of treating physician the trial treatment does not pose excessive risk of infection to the patient.
• Platelets >100K/UL
• Hemoglobin ≥ 9 g/dL
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using the Cockcroft-Gault equation
• Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ 1 x ULN
• Aspartate aminotransferase and alanine aminotransferase ≤ 1.5 x ULN
• Women of child-bearing potential and men with partners of childbearing potential must agree to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for 30 days following completion of therapy.

Exclusion Criteria

• Concurrent invasive malignancy or invasive malignancy within 2 years except for chronic lymphocytic leukemia/small lymphocytic lymphoma on surveillance, suspected or proven clinical stage 1 (cT1) renal cell carcinoma on active surveillance, or the following malignancies treated with curative intent via surgical resection: carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, low-grade non-muscle-invasive urothelial carcinoma, non-melanoma skin cancer.
• Simultaneously enrolled in any therapeutic clinical trial
• Current or anticipating use of other pharmacologic anti-neoplastic (including hormonal), or investigational agents while participating in this study. Concurrent treatment with radiotherapy is permitted.
• Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
• Has a known allergic reaction to any excipient contained in the study drug formulation
• Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
• Participants using the following medications within 2 weeks prior to first dosing (or within 5 times the half-life of that medication, whichever is longer) will be excluded from the study:

• Inhibitors of CYP3A4 (including but not limited to macrolide antibiotics, HIV protease inhibitor, azole antifungal drugs, cyclosporine, calcium channel inhibitor, cimetidine)
• Inducers of CYP3A4 (including but not limited to rifampicin, carbamazepine, efavirenz, bosentan, modafinil, St. John's Wort), Medications with narrow therapeutic index that are metabolized CYP3A4 and/or CYP2D6 are not allowed from screening until up to 5 half-lives after last dose of Osanetant is administered.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Kansas Cancer Center, Westwood Campus

Kansas City, Kansas, United States

Countries

United States

Other Identifiers

STUDY00148766

Identifier Type: -

Identifier Source: org_study_id