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Irofulven in AR-targeted and Docetaxel-Pretreated mCRPC Patients With Drug Response Predictor (DRP®) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Irofulven in AR-targeted and Docetaxel-Pretreated mCRPC Patients With Drug Response Predictor (DRP®)

Phase II Study of Irofulven in AR-targeted and Docetaxel-Pretreated Metastatic Castration-Resistant Prostate Cancer Patients, Who Have a Drug Response Predictor (DRP®) Indicating a High Likelihood of Response to Irofulven.

NCT03643107•Allarity Therapeutics

View on ClinicalTrials.gov

Summary

The study seek to evaluate the anti-tumor effect after treatment of Irofulven in combination with prednisolone in patients who progressed on androgen receptor(AR)-targeted therapy and Docetaxel-Pretreated Metastatic Castration-Resistant Prostate Cancer Patients. A drug response predictor (DRP®) biomarker in prostate cancer patients will identify patients likely to respond to and benefit from treatment with Irofulven.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Have a histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate (carcinomas with pure small-cell histology or pure high grade neuroendocrine histology are excluded; neuroendocrine differentiation is allowed)
•Surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL. For patients currently being treated with luteinizing hormone-releasing hormone (LHRH) agonists, i.e., patients who have not undergone an orchiectomy, therapy must be continued throughout the study
•Have evidence of disease progression after prior therapy for mCRPC:
•Disease progression after treatment with at least 1 but no more than 2 prior next-generation AR-targeted therapies (abiraterone acetate, enzalutamide, or investigational AR-targeted agent) for metastatic prostate cancer (treatment with the older anti-androgen therapies such as bicalutamide, flutamide, and nilutamide are not counted toward this limit), AND
•Disease progression after treatment with docetaxel for metastatic prostate cancer. Prior Docetaxel therapy administered for hormone-sensitive disease is permitted and is not counted toward this limit
•Disease progression after initiation of most recent therapy is based on any of the following criteria:
•Rise in PSA: a minimum of 2 consecutive rising levels, with an interval of ≥ 1 week between each determination. The most recent screening measurement must have been ≥ 1 ng/mL
•Transaxial imaging: new or progressive soft tissue masses on CT or MRI scans as defined by RECIST 1.1
•Radionuclide bone scan: at least 2 new metastatic lesions
•Signed informed consent obtained prior to initiation of any study-specific procedures or treatment.
+9 more criteria

Exclusion Criteria

•Prior external beam radiation therapy to \>25% of the bone marrow
•Contraindication to the use of prednisolone (e.g. uncontrolled diabetes mellitus)
•Prior treatment with Irofulven.
•Ongoing treatment with a corticosteroid at a prednisolone-equivalent dose \> 10 mg/day
•More than 1 prior treatment with either isotopes Sm or Sr, or radioisotope treatment or treatment with bisphosphonate agents or antibody treatment i.e., denosumab within 2 months prior to initiation of treatment with investigational Medicinal Product (IMP). Pre-existing treatment with bisphosphonate agents or denosumab is to be continued during the study
•Initiation of treatment with bisphosphonate agents or antibody treatment i.e., denosumab, within 4 weeks of study start. Pre-existing treatment with bisphosphonate agents or denosumab is to be continued during the study
•Treatment with coumarin derivatives and/or phenytoin most be discontinued and coagulation parameters most be within the normal range before treatment with Irofulven
•History of significant gastric or small bowel resection, malabsorption syndrome, or other lack of integrity of the upper gastrointestinal tract that may prevent compliance with oral drug administration
•Presence of any serious concomitant systemic disorders and/or psychiatric condition incompatible with the study (at the investigators discretion)
•History of retinopathy
+2 more criteria

Locations (1)

Rigshospitalet, Dept. Of Oncology

Copenhagen, Denmark

Key Dates

Start Date

October 17, 2018

Primary Completion Date

October 1, 2021

Completion Date

August 1, 2022

Last Updated

January 23, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic Castration-Resistant Prostate Cancer Patients

Interventions

Irofulven

DRUG

Prednisolone 10 mg

COMBINATION_PRODUCT

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

NCT07103018

Metastatic Castration-resistant Prostate CancerMetastatic Castration-Resistant Prostate Cancer Patients+3 more

View study

RECRUITINGPHASE1

A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of [225Ac]Ac-PSMA-XT Injection in Patients With Metastatic Castration-resistant Prostate Cancer

NCT07135102

Metastatic Castration-Resistant Prostate Cancer Patients

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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