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Metastatic Castration-Resistant Prostate Cancer PatientsPhase 2NCT03643107

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

A Phase 2 study testing Irofulven and Prednisolone 10 mg in people with Metastatic Castration-Resistant Prostate Cancer Patients, run by Allarity Therapeutics at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Irofulven and Prednisolone 10 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteDenmark
Study dates
17 Oct 2018to 1 Aug 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.
  • Age ≥ 18 years
  • Life expectancy ≥ 3 months
  • Performance status 0 - 1
  • Have participated in the Irofulven screening protocol in which the Drug Response Predictor (DRP) outcome is measured as being in the upper limit of response (defined as being in the top 20%). Scaling can be modified depending on the clinical outcome.
  • Adequate organ functions
  • Hematological: absolute neutrophil count (ANC) >1.5 x 10E9/L, platelet count >100 x 10E9/L, hemoglobin ≥ 6.2 mmol/L
  • Hepatic: Bilirubin within normal range, aspartate transaminase (AST) and alanine transaminase (ALT) ≥ 2.5 upper normal limit (UNL), albumin > 25 g/L
  • Renal: creatinine clearance ≥ 30 mL/min (calculated according to the Cockcroft and Gault method)
  • Recovered to grade 0 or 1 from any toxic effects of prior chemotherapy, radiotherapy

Who cannot join

  • 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
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  • 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
  • Presence of any active infection (at the investigators discretion).
  • Central Nervous System Disease (CNS) disease including epilepsy or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study procedures

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet, Dept. Of Oncology

    Copenhagen, 2100

Other trials in Denmark

About this study

Official title: 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.

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.

Being tested
Irofulven, Prednisolone 10 mg
Keywords
Drug Response Prediction (DRP)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IrofulvenDrug

    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.

  • Prednisolone 10 mgCombination product

    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.

Study groups in NCT03643107
Study groupRoleWhat they receive
Irofulven + Prednisolone 10mgExperimentalIrofulven 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.
Receives: Drug: Irofulven; Combination Product: Prednisolone 10 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti-tumor effect of Irofulven with prednisolone

    Objective response rate defined as complete response, partial response or stable disease > 9 weeks according to RECIST 1.1 for patients with measurable disease and defined as stable disease > 9 weeks according to Prostate Cancer Working Group 3 (PCWG3) for bone metastases

    Measured: one year

Secondary outcomes (6)

  1. Duration of response (DOR)

    Time from documentation of tumor response to disease progression

    Measured: one year

  2. Radiologic progression free survival (rPFS)

    rPFS defined as ≥ two new lesions on an 8-week bone scan plus two additional lesions on a confirmatory scan, ≥ two new confirmed lesions on any scan ≥ 9 weeks after enrolment, and/or progression in nodes or viscera on cross-sectional imaging, or death.

    Measured: one year

  3. Overall survival

    Time from enrolment until death from any cause.

    Measured: one year

  4. Prostate Specific Antigen (PSA) response

    ≥ 50% decline in PSA compared to baseline in all patients according to PCWG3

    Measured: one year

  5. PSA response

    ≥ 90% decline in PSA compared to baseline in all patients according to PCWG3

    Measured: one year

  6. Time to PSA progression

    PSA progression defined in accordance with PCWG3.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2018
  2. Study start17 Oct 2018
  3. Primary completion1 Oct 2021
  4. Study completion1 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03643107
Sponsor's protocol ID
SMR-3165
Other IDs
2017-003549-72, 2017
Status last verified
Jan 2025
First submitted
21 Aug 2018
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irofulven and Prednisolone 10 mg in people with Metastatic Castration-Resistant Prostate Cancer Patients, run by Allarity Therapeutics at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-tumor effect of Irofulven with prednisolone (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03643107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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