RECRUITING

Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer

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Conditions

Prostatic Neoplasms, Castration-ResistantMetastatic Castration-Resistant Prostate CancerFASN Inhibitor

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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

The purpose of this study is to determine what effects (good and bad) Enzalutamide and TVB-2640 have in the treatment of prostate cancer whose prostate cancer has spread to other parts of their body and that has not gotten better with previous treatment. This study is a Phase I clinical trial. Phase I clinical trials test the side effects of an investigational drug or an investigational combination with another drug. "Investigational" means that the drug is still being studied and research doctors are trying to find out more about it. Although Enzalutamide is already being used to treat men with prostate cancer, combining Enzalutamide with TVB-2640 together in patients with prostate cancer is considered experimental. This research study is being done because additional effective treatments are needed for prostate cancer that has spread and is growing despite hormone suppression. By doing this study, the investigators hope to learn if combining Enzalutamide with TVB-2640 can be done safely. Participation in this research will last about 12 to 24 months after enrollment.

Official Title

A Phase I, Open-Label, Dose-Finding Study of TVB-2640 Administered in Combination With Enzalutamide (Xtandi) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Quick Facts

Study Start:2023-11-20
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05743621

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.
  2. * Diagnosis of metastatic, castration resistant prostate cancer
  3. * Potential participant must be planning to receive Enzalutamide as their first line of therapy for castration resistant prostate cancer or have previously received up to one line of Abiraterone or an androgen receptor antagonist
  4. * No prior treatment with cytotoxic chemotherapy
  5. * Willing to undergo a tumor biopsy prior to beginning therapy, if recent tissue samples are not available
  6. * Agree to undergo a tumor biopsy of at least one metastatic site or primary prostate after \~4 weeks of therapy with both agents
  7. * Participants without prior orchiectomy must be currently taking and willing to continue luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) therapy until permanent discontinuation of study treatment
  8. * Sexually active, fertile participants and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom with spermicide during the course of the study and for 4 months after the last dose of study treatment
  9. * Capable of understanding and complying with the protocol requirements and must have signed the informed consent document
  1. * Any prior cytotoxic chemotherapy for hormone sensitive prostate cancer.
  2. * Receipt of any type of biologic, or other systemic anticancer therapy (including investigational) except agents within 4 weeks before first dose of study treatment. Anti-resorptive bone agents are also allowed.
  3. * Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
  4. * Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment for neurological indications at the time of first dose of study treatment.
  5. * Participants with clinically significant dry eye or corneal abnormalities
  6. * Participants with a history of seizure
  7. * Currently taking certain anticoagulation medications, such as coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel)
  8. 10. The subject has uncontrolled, significant intercurrent or recent Cardiovascular disorders including, but not limited to, the following conditions: i. Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias.
  9. * Inability to swallow tablets.
  10. * Use of herbal products that may decrease PSA levels within 4 weeks prior to enrollment
  11. * Previously identified allergy or hypersensitivity to components of the study treatment formulations.
  12. * Diagnosis of another type of cancer within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy.

Contacts and Locations

Study Contact

Caroline Cassidy
CONTACT
646-962-6816
cca4008@med.cornell.edu
Escarleth Fernandez
CONTACT
646-962-9406
esf4001@med.cornell.edu

Principal Investigator

David Nanus, M.D.
PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University

Study Locations (Sites)

Weill Cornell Medicine/NewYork-Presbyterian Hospital
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

  • David Nanus, M.D., PRINCIPAL_INVESTIGATOR, Weill Medical College of Cornell University

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 Date2023-11-20
Study Completion Date2027-11

Study Record Updates

Study Start Date2023-11-20
Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

  • Metastatic Castration-Resistant Prostate Cancer
  • FASN Inhibitor

Additional Relevant MeSH Terms

  • Prostatic Neoplasms, Castration-Resistant