RECRUITING

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 1/2, open-label, randomized, dose finding and dose expansion study to evaluate the safety, preliminary efficacy, and PK of gedatolisib in combination with darolutamide in subjects with mCRPC.

Official Title

A Phase 1/2, Open-Label, Randomized, Dose Finding and Dose Expansion Study of Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Quick Facts

Study Start:2024-01-01
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06190899

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Genelle Brower, RN
CONTACT
844-310-3900
gbrower@celcuity.com

Principal Investigator

Nadene Zack, MS
STUDY_DIRECTOR
Celcuity Inc

Study Locations (Sites)

Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States

Collaborators and Investigators

Sponsor: Celcuity Inc

  • Nadene Zack, MS, STUDY_DIRECTOR, Celcuity Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-01
Study Completion Date2027-11

Study Record Updates

Study Start Date2024-01-01
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • Gedatolisib
  • PI3K
  • Protein Kinase Inhibitors
  • mCRPC (metastatic castration-resistant prostate cancer)
  • Darolutamide
  • Prostate Cancer
  • Prostatic Neoplasms, Castration-Resistant
  • Prostatic Disease
  • Urogenital Diseases, Male
  • Genital Diseases, Male

Additional Relevant MeSH Terms

  • mCRPC (Metastatic Castration-resistant Prostate Cancer)
  • Genital Diseases, Male
  • Urogenital Diseases, Male
  • Prostatic Disease
  • Prostatic Neoplasms, Castration-Resistant
  • Prostate Cancer