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

NCT03643107 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-01-23

No results posted yet for this study

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.

Conditions

  • Metastatic Castration-Resistant Prostate Cancer Patients

Interventions

DRUG

Irofulven

Irofulven will be administered as an intravenous dose of 0.45 mg/kg, over a 30-minute infusion period by venous access at day 1 and 8 of a three week cycle. Irofulven will be administered in combination with a daily dose of 10 mg orally administered prednisolone.

COMBINATION_PRODUCT

Prednisolone 10 mg

Irofulven will be administered as an intravenous dose of 0.45 mg/kg, over a 30-minute infusion period by venous access at day 1 and 8 of a three week cycle. Irofulven will be administered in combination with a daily dose of 10 mg orally administered prednisolone.

Sponsors & Collaborators

  • Smerud Medical Research International AS

    collaborator OTHER

  • Lantern Pharma Inc.

    collaborator INDUSTRY

  • Allarity Therapeutics

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-17
Primary Completion
2021-10-01
Completion
2022-08-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03643107 on ClinicalTrials.gov