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Hormone Therapy

Opaganib + Androgen Antagonists for Prostate Cancer

Phase 2
Waitlist Available
Led By Michael Lilly, MD
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have mCRPC
Patients must have adenocarcinoma, or ductal carcinoma, or combinations of these two entities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 113 days
Awards & highlights

Study Summary

This trial is testing an experimental drug, opaganib, on men with prostate cancer that has progressed despite treatment with abiraterone or enzalutamide. Patients will take the drug twice a day continuously until the disease progresses, they experience intolerable side effects, or they withdraw from the trial.

Who is the study for?
Men aged 18+ with metastatic castration-resistant prostate cancer (mCRPC) who've seen their disease progress on abiraterone or enzalutamide. They must have acceptable liver and kidney function, stable blood counts, controlled blood sugar and pressure, and an ECOG performance status of 0-2. Excluded are those with severe heart issues, psychiatric illness requiring hospitalization within two years, active infections needing systemic therapy, or involvement in another clinical trial.Check my eligibility
What is being tested?
The study is testing the effectiveness of Opaganib at doses of either 250 mg or 500 mg taken orally twice daily by patients with mCRPC who have not responded to standard treatments like Enzalutamide or Abiraterone. The trial will continue until disease progression, unacceptable side effects occur, consent withdrawal or other specified events.See study design
What are the potential side effects?
While specific side effects for Opaganib aren't listed here, common ones for cancer drugs include nausea, fatigue, liver function changes, potential blood disorders such as low platelet count or neutrophils (which can increase infection risk), digestive issues and possible glucose metabolism alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is metastatic castration-resistant prostate cancer.
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My cancer is either adenocarcinoma, ductal carcinoma, or a mix of both.
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My cancer progressed despite treatment with enzalutamide or abiraterone.
Select...
My kidney function is within normal limits.
Select...
I am 18 years old or older.
Select...
My blood counts meet the required levels for treatment.
Select...
I am able to care for myself and perform daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~113 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 113 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease control status

Side effects data

From 2021 Phase 2 & 3 trial • 475 Patients • NCT04467840
10%
Constipation
8%
Respiratory failure
7%
Insomnia
5%
Alanine aminotransferase increased
5%
Nausea
4%
Pneumonia
4%
Acute respiratory failure
4%
Hyperkalaemia
3%
Diarrhoea
3%
Pyrexia
3%
Aspartate aminotransferase increased
3%
Dyspepsia
3%
Pulmonary embolism
3%
Headache
3%
Hypotension
3%
Anxiety
3%
Oedema peripheral
2%
Tachypnoea
2%
Dizziness
2%
Anaemia
2%
Tachycardia
2%
Septic shock
2%
Hypokalaemia
2%
Back pain
2%
Thrombocytopenia
2%
Vomiting
2%
Atrial fibrillation
2%
Hypertension
2%
Acute kidney injury
1%
Blood pressure increased
1%
Pneumonia bacterial
1%
Multiple organ dysfunction syndrome
1%
Sepsis
1%
Hyperglycaemia
1%
Renal impairment
1%
Adrenal insufficiency
1%
Depression
1%
Arrhythmia
1%
Urinary tract infection
1%
Phlebitis
1%
Thrombophlebitis
1%
Electrocardiogram QT prolonged
1%
Abdominal pain
1%
Abdominal pain upper
1%
Abdominal wall haematoma
1%
Decubitus ulcer
1%
Steroid diabetes
1%
Hypophosphataemia
1%
Herpes virus infection
1%
Renal failure
1%
Acute respiratory distress syndrome
1%
Decreased appetite
1%
Cough
1%
C-reactive protein increased
1%
Metabolic acidosis
1%
Leukocytosis
1%
Oral candidiasis
1%
Hyperhidrosis
1%
Hepatic enzyme increased
1%
Deep vein thrombosis
1%
Pneumothorax
1%
Staphylococcal sepsis
1%
Transaminases increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Opaganib
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 3: Opaganib with enzalutamideExperimental Treatment2 Interventions
Group II: Cohort 2: Opaganib with abirateroneExperimental Treatment2 Interventions
Group III: Cohort 1b: Opaganib with enzalutamideExperimental Treatment2 Interventions
Group IV: Cohort 1a: Opaganib with abirateroneExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Opaganib
2020
Completed Phase 3
~540
Enzalutamide
2014
Completed Phase 4
~2760
Abiraterone
2012
Completed Phase 4
~2830

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,323 Total Patients Enrolled
18 Trials studying Prostate Cancer
712 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,600 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,106 Patients Enrolled for Prostate Cancer
Michael Lilly, MDPrincipal InvestigatorMedical University of South Carolina
9 Previous Clinical Trials
147 Total Patients Enrolled
4 Trials studying Prostate Cancer
59 Patients Enrolled for Prostate Cancer

Media Library

Abiraterone (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04207255 — Phase 2
Prostate Cancer Research Study Groups: Cohort 2: Opaganib with abiraterone, Cohort 3: Opaganib with enzalutamide, Cohort 1a: Opaganib with abiraterone, Cohort 1b: Opaganib with enzalutamide
Prostate Cancer Clinical Trial 2023: Abiraterone Highlights & Side Effects. Trial Name: NCT04207255 — Phase 2
Abiraterone (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04207255 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still being accepted into the program?

"Yes, this clinical trial is currently recruiting participants. The primary posting was on March 27th, 2020 with the most recent edit occurring on October 25th, 2022 according to the website clinicaltrials.gov."

Answered by AI

Are there long-term repercussions to taking Opaganib?

"Opaganib received a safety rating of 2 because, while there is some evidence that the drug is safe, none exists to support its efficacy."

Answered by AI

What previous studies have been done using Opaganib?

"As of now, there are 177 clinical trials worldwide that are currently studying the efficacy of Opaganib. Out of these177 studies, 45 are in Phase 3. Most of these trials take place in Istanbul and Tessin; however, there are 9828 total locations where Opaganib is being studied."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Addition of Opaganib to Androgen Antagonists in Patients With mCRPC
2020. "Addition of Opaganib to Androgen Antagonists in Patients With mCRPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04207255.
~13 spots leftby Apr 2025
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