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Androgen Receptor Inhibitor

Phase 1 Arm 1 for Prostate Disease

Q: Is the recruitment for this study still ongoing at present?

<p>According to the information found on clinicaltrials.gov, this specific trial is not currently seeking participants. The trial was initially posted on January 1st, 2024 and was last updated on January 2nd, 2024. However, it's worth noting that there are currently a total of 1304 ongoing trials actively recruiting patients at this time.</p>

Q: At how many different sites is the administration of this trial being managed?

<p>Currently, this trial is being conducted at 14 different sites. These sites are spread across various locations, including Detroit, Villejuif, Barcelona, and 11 other places. To minimize travel requirements, it would be advantageous to select the clinic nearest to your location when enrolling in the study.</p>

Phase 1 & 2

Recruiting

Research Sponsored by Celcuity Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate without a small cell component and with <10% neuroendocrine type cells

Eastern Cooperative Oncology Group (ECOG) performance status score ≤1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through phase i completion, an average of 1 year.

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a drug called gedatolisib in combination with darolutamide for people with a specific type of advanced prostate cancer.

Who is the study for?

This trial is for men with metastatic castration-resistant prostate cancer (mCRPC). Specific eligibility details are not provided, but typically participants would need to meet certain health standards and have no conflicting conditions.Check my eligibility

What is being tested?

The study is testing the combination of two drugs, Gedatolisib and Darolutamide, in patients with mCRPC. It's an early-stage trial to find out the right doses and see how well these drugs work together.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones for cancer treatments like Gedatolisib and Darolutamide may include fatigue, nausea, skin reactions, hormonal changes, and potential impacts on liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is mainly adenocarcinoma without significant neuroendocrine features.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My cancer progressed despite treatment with a specific prostate cancer medication.

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I am on hormone therapy for cancer and have not had both testicles removed.

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I am a man and I am 18 years old or older.

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My prostate cancer has spread and is not responding to hormone therapy.

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My metastatic disease was confirmed by CT, MRI, or bone scan.

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My prostate cancer is worsening despite treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through phase i completion, an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through phase i completion, an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through phase i completion, an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1: Assessment of the safety and tolerability of gedatolisib in combination with darolutamide in metastatic castration-resistant prostate cancer (mCRPC)

Phase 1: Identification of the recommended Phase 2 dose (RP2D) of gedatolisib in combination with darolutamide in mCRPC

Phase 2: Assessment of the antitumor activity of gedatolisib in combination with darolutamide in each arm as demonstrated by radiographic progression-free survival (rPFS) by arm

Secondary outcome measures

Assessment of the preliminary efficacy of gedatolisib in combination with darolutamide by arm

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment2 Interventions

The recommended Phase 2 dose (RP2D) of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle)

Group II: Phase 1 Arm 2Experimental Treatment2 Interventions

Arm 2 - 180 mg of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle)

Group III: Phase 1 Arm 1Experimental Treatment2 Interventions

Arm 1 - 120 mg of gedatolisib (administered once weekly for 3 weeks on/1 week off) in combination with darolutamide 600 mg (two 300 mg tablets) orally administered twice daily (equivalent to a total daily dose of 1200 mg on Days 1-28 of each cycle)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gedatolisib

2018

Completed Phase 1

~160

Darolutamide

2018

Completed Phase 2

~100

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Celcuity IncLead Sponsor

7 Previous Clinical Trials

962 Total Patients Enrolled

Nadene Zack, MSStudy DirectorCelcuity Inc

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment for this study still ongoing at present?

"According to the information found on clinicaltrials.gov, this specific trial is not currently seeking participants. The trial was initially posted on January 1st, 2024 and was last updated on January 2nd, 2024. However, it's worth noting that there are currently a total of 1304 ongoing trials actively recruiting patients at this time."

Answered by AI

At how many different sites is the administration of this trial being managed?

"Currently, this trial is being conducted at 14 different sites. These sites are spread across various locations, including Detroit, Villejuif, Barcelona, and 11 other places. To minimize travel requirements, it would be advantageous to select the clinic nearest to your location when enrolling in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06190899.

All > Advanced Prostate Cancer > Recurrent Prostate Cancer