Continued Darolutamide Treatment for Cancer

Recruiting in Palo Alto (17 mi)

+219 other locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Bayer

Must be taking: Darolutamide

Disqualifiers: Non-compliance, Negative benefit/risk, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial continues darolutamide treatment for patients who were part of a previous study and are believed to benefit from it. Darolutamide helps by blocking hormones that can make cancer cells grow. Patients will keep taking the same dosage and visit their doctors regularly. Darolutamide has been shown to slow cancer spread and improve survival in patients with nonmetastatic castration-resistant prostate cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on continuing darolutamide treatment for those already on it.

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

Darolutamide has been shown to be effective in treating prostate cancer, specifically in prolonging survival in men with metastatic hormone-sensitive prostate cancer and delaying metastasis in non-metastatic castration-resistant prostate cancer. It is generally well tolerated and has a low risk of causing central nervous system-related side effects.

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Is darolutamide safe for humans?

Darolutamide, also known as Nubeqa, has been generally well tolerated in clinical trials for prostate cancer, with a low chance of causing central nervous system-related side effects compared to similar treatments. It has a manageable safety profile when used with other therapies, and adverse events reported are consistent with those of other treatments used in combination.

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Eligibility Criteria

This trial is for patients who have been part of a previous Bayer-supported study on Darolutamide and are seeing benefits from its use. They must be able to consent, follow the study's rules, not have met any discontinuation criteria previously, and agree to continue using birth control.

Inclusion Criteria

I can sign and agree to follow the study's rules.

Participants who have not met any treatment discontinuation criteria in the feeder study protocol.

Willingness to continue practicing acceptable methods of birth control during the study.

Exclusion Criteria

The investigator has determined that the possible risks of the study outweigh the potential benefits for you.

I meet the criteria to stop my current clinical trial treatment.

Participant is unable to comply with the requirements of the study.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue treatment with darolutamide at the same dosage as in previous studies

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The trial continues treatment with Darolutamide (Nubeqa) for cancer patients carried over from prior studies. The dosage remains the same, and participants will visit doctors as before to assess the ongoing effectiveness and safety of the drug.

Group I: Darolutamide (BAY1841788) Experimental Treatment 1 Intervention

Participants enrolled in the current study will use the dose they were assigned to in the feeder study they come from.

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

🇺🇸 Approved in United States as Nubeqa for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

🇪🇺 Approved in European Union as Nubeqa for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

🇨🇦 Approved in Canada as Nubeqa for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

🇦🇺 Approved in Australia as Nubeqa for:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Centre Hospitalier de l'Universite de Montreal Montreal, Canada

Tom Baker Cancer Centre Calgary, Canada

CHUM - Hopital Notre-Dame Montreal, Canada

Inova Fairfax Hospital Falls Church, VA

More Trial Locations

Who Is Running the Clinical Trial?

Bayer Lead Sponsor

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Darolutamide: First Approval. [2020] Darolutamide (NUBEQA™) is a structurally distinct non-steroidal androgen receptor antagonist being developed by Orion and Bayer as a treatment for prostate cancer. Based on positive results in the phase III ARAMIS trial, darolutamide was recently approved in the USA for the treatment of men with non-metastatic castration-resistant prostate cancer. This article summarizes the milestones in the development of darolutamide leading to this first approval.

2. France pubmed.ncbi.nlm.nih.gov

Darolutamide: A Review in Non-Metastatic Castration-Resistant Prostate Cancer. [2022] Oral darolutamide (Nubeqa™) is a novel second-generation, nonsteroidal, selective androgen receptor (AR) inhibitor indicated for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). In the pivotal multinational, phase 3 ARAMIS trial in men with nmCRPC, relative to placebo plus ongoing androgen deprivation therapy (ADT), darolutamide (+ ADT) significantly prolonged metastasis-free survival (MFS) at the time of the primary analysis and overall survival (OS) at the time of the final OS analysis and was generally well tolerated in extended follow-up. Albeit long-term data from the real-world setting are required to fully define the safety profile of darolutamide, current evidence from the final ARAMIS analysis indicates that darolutamide has a low propensity for CNS-related adverse events (AEs) associated with other currently approved second-generation AR inhibitors. Given the efficacy and safety evidence from the final ARAMIS analysis and the key role of second-generation AR inhibitors in the management of nmCRPC, darolutamide + ADT represents an important emerging option for the treatment of men with nmCRPC who are at high risk of developing metastatic prostate cancer.

3. France pubmed.ncbi.nlm.nih.gov

Darolutamide: A Review in Metastatic Hormone-Sensitive Prostate Cancer. [2023] Darolutamide (NUBEQA®) is an oral androgen receptor inhibitor (ARi) that is approved for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) and docetaxel. In a pivotal trial, darolutamide plus ADT and docetaxel was superior to placebo plus ADT and docetaxel in prolonging the primary endpoint of overall survival, with improvements also reported in most secondary endpoints. Treatment with darolutamide plus ADT and docetaxel was associated with a manageable tolerability profile. Furthermore, the adverse events reported with darolutamide plus ADT and docetaxel were generally consistent with the safety profiles previously reported for ADT and docetaxel. Darolutamide expands the availability of treatment options in mHSPC and may be useful as a treatment for high-volume disease (typically defined as ≥ 4 bone metastases with spread outside of the pelvis and vertebral column).

4. Germany pubmed.ncbi.nlm.nih.gov

Phase 1 study of darolutamide (ODM-201): a new-generation androgen receptor antagonist, in Japanese patients with metastatic castration-resistant prostate cancer. [2023] This trial assessed the safety, pharmacokinetics, and efficacy of darolutamide (ODM-201), a new-generation nonsteroidal androgen receptor antagonist, in Japanese patients with metastatic castration-resistant prostate cancer (mCRPC).

5. United States pubmed.ncbi.nlm.nih.gov

Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer. [2022] Darolutamide is a structurally unique androgen-receptor antagonist that is under development for the treatment of prostate cancer. We evaluated the efficacy of darolutamide for delaying metastasis and death in men with nonmetastatic, castration-resistant prostate cancer.

6. Spain pubmed.ncbi.nlm.nih.gov

Darolutamide for treatment of castration-resistant prostate cancer. [2020] Darolutamide is a novel, nonsteroidal androgen receptor (AR)-signaling inhibitor. It serves as a second-generation antiandrogen and is currently indicated for the treatment of patients with nonmetastatic castration-resistant prostate cancer (nmCRPC). The product was approved by the United States Food and Drug Administration (FDA) in July 2019 and by the Japanese Ministry of Health, Labour and Welfare (MHLW) in January 2020 for the treatment of men with nmCRPC, and is awaiting approval in the E.U. for the same indication. This review will cover the background, preclinical development, safety, pharmacokinetics, pharmacodynamics and clinical studies that led to the approval of darolutamide. The key clinical data, ongoing trials and future directions for darolutamide are also discussed herein.