54 Participants Needed

Gedatolisib + Darolutamide for Prostate Cancer

Recruiting at 13 trial locations
GB
Overseen ByGenelle Brower, RN
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: Celcuity Inc
Must be taking: LHRH analogs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop taking any androgen receptor inhibitors at least 4 weeks before starting the study drug. You also need to be at least 2 weeks beyond treatment with targeted therapy or major surgery, and 3 weeks beyond any other systemic anticancer therapy or radiation therapy.

Is the combination of Gedatolisib and Darolutamide safe for humans?

Darolutamide, used for prostate cancer, has been generally well tolerated in trials, with a low chance of causing brain-related side effects compared to similar drugs. It has a manageable safety profile when combined with other treatments like androgen deprivation therapy and docetaxel.12345

What makes the drug combination of Gedatolisib and Darolutamide unique for prostate cancer treatment?

The combination of Gedatolisib and Darolutamide is unique because Darolutamide is a next-generation androgen receptor inhibitor that has a low risk of causing central nervous system side effects, unlike other similar drugs. This makes it a potentially safer option for patients, especially when combined with Gedatolisib, which may offer additional therapeutic benefits.12567

What data supports the effectiveness of the drug Darolutamide for prostate cancer?

Darolutamide has been shown to significantly prolong survival in men with non-metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer when used with other therapies, according to several clinical trials. It is generally well tolerated and has a low risk of causing central nervous system side effects.12568

Who Is on the Research Team?

NZ

Nadene Zack, MS

Principal Investigator

Celcuity Inc

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am fully active and can carry on all my pre-disease activities without restriction.
My cancer progressed despite treatment with a specific prostate cancer medication.
My prostate cancer is mainly adenocarcinoma without significant neuroendocrine features.
See 8 more

Exclusion Criteria

I have had cancer before, but it was either skin cancer treated successfully or another type of cancer that has been gone for over 3 years.
My prostate cancer has a small cell component with at least 10% neuroendocrine cells.
I have been treated with a PI3K, AKT, or mTOR inhibitor before.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Dose finding to evaluate safety and determine the recommended Phase 2 dose of gedatolisib in combination with darolutamide

1 year
Weekly visits for gedatolisib administration

Phase 2 Treatment

Assessment of safety and preliminary efficacy of the recommended Phase 2 dose of gedatolisib in combination with darolutamide

6 months
Weekly visits for gedatolisib administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days post last dose

Long-term Follow-up

Assessment of radiographic progression-free survival and overall survival

24 months post Cycle 1 Day 1

What Are the Treatments Tested in This Trial?

Interventions

  • Darolutamide
  • Gedatolisib
Trial Overview 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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment2 Interventions
Group II: Phase 1 Arm 2Experimental Treatment2 Interventions
Group III: Phase 1 Arm 1Experimental Treatment2 Interventions

Darolutamide is already approved in United States, European Union, Canada for the following indications:

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Approved in United States as Nubeqa for:
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Approved in European Union as Nubeqa for:
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Approved in Canada as Nubeqa for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Celcuity Inc

Lead Sponsor

Trials
9
Recruited
1,600+

Published Research Related to This Trial

In the phase 3 ARAMIS trial, darolutamide significantly improved metastasis-free survival and overall survival in men with non-metastatic castration-resistant prostate cancer compared to placebo, indicating its efficacy when combined with ongoing androgen deprivation therapy.
Darolutamide was generally well tolerated, showing a low risk of central nervous system-related side effects, which is a common concern with other second-generation androgen receptor inhibitors.
Darolutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer.Scott, LJ.[2022]
Darolutamide has shown significant efficacy in improving metastasis-free survival in patients with non-metastatic castration-resistant prostate cancer, as demonstrated in the ARAMIS trial.
The treatment landscape for advanced prostate cancer is evolving, with darolutamide being evaluated in ongoing studies for its potential benefits in combination with docetaxel for metastatic castration-sensitive prostate cancer.
Darolutamide For Castration-Resistant Prostate Cancer.Bastos, DA., Antonarakis, ES.[2020]
Darolutamide (NUBEQA™) is a new non-steroidal androgen receptor antagonist approved for treating non-metastatic castration-resistant prostate cancer in men, based on positive results from the phase III ARAMIS trial.
The approval of darolutamide marks a significant milestone in prostate cancer treatment, highlighting its efficacy and safety profile as demonstrated in clinical trials.
Darolutamide: First Approval.Markham, A., Duggan, S.[2020]

Citations

Darolutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer. [2022]
Darolutamide For Castration-Resistant Prostate Cancer. [2020]
Darolutamide: First Approval. [2020]
Darolutamide: A Review in Metastatic Hormone-Sensitive Prostate Cancer. [2023]
Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. [2022]
Phase 1 study of darolutamide (ODM-201): a new-generation androgen receptor antagonist, in Japanese patients with metastatic castration-resistant prostate cancer. [2023]
A Randomized, Open-label, Cross-over Phase 2 Trial of Darolutamide and Enzalutamide in Men with Asymptomatic or Mildly Symptomatic Metastatic Castrate-resistant Prostate Cancer: Patient Preference and Cognitive Function in ODENZA. [2023]
Clinical Pharmacokinetics and Pharmacodynamics of the Next Generation Androgen Receptor Inhibitor-Darolutamide. [2023]
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