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Androgen Receptor Inhibitor

Gedatolisib + Darolutamide for Prostate Cancer

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

Must not have

Adenocarcinoma of the prostate with a small cell component, and with ≥10% neuroendocrine type cells

Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (AKT) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate cancer has a small cell component with at least 10% neuroendocrine cells.

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I have been treated with a PI3K, AKT, or mTOR inhibitor before.

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I cannot absorb pills due to my stomach or bowel problems.

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I have a history of serious heart problems.

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I have untreated brain or spinal cord cancer spread.

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My diabetes is not under control.

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I cannot swallow pills.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Darolutamide

2018

Completed Phase 2

~100

Gedatolisib

2018

Completed Phase 1

~160