Prostate CancerPhase 2NCT04207255
Addition of Opaganib to Androgen Antagonists in Patients With mCRPC
A Phase 2 study testing Opaganib, Abiraterone and Enzalutamide in people with Prostate Cancer, run by Medical University of South Carolina at 2 sites in United States.
Trial summary
This is a Phase II study of the investigational drug opaganib. Patients with metastatic castration resistant prostate cancer (mCRPC) who have experienced disease progression while receiving abiraterone or enzalutamide will receive Opaganib at either 250 mg or 500 mg by mouth twice a day continuously. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Opaganib, Abiraterone and Enzalutamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Mar 2020to 31 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient must have mCRPC. Each patient must have:
- Tissue diagnosis documented by pathology report, or clinic note attesting to same.
- Radiographically-demonstrated metastases
- Patients must have adenocarcinoma, or ductal carcinoma, or combinations of these two entities
- Voluntary, signed and dated, institutional review board (IRB)-approved informed consent form in accordance with regulatory and institutional guidelines.
- Documented progression during treatment with enzalutamide or abiraterone, as determined by the enrolling investigator.
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- Testosterone level documented to be less than 50ng/
- 18 years of age or older.
- ECOG performance status of 0-2.
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal (CTCAE Grade 1 baseline)
- AST (SGOT) \& ALT (SGPT) ≤ 3 x ULN (CTCAE Grade 1 baseline)
- Subjects with Gilbert's syndrome may be included if the total bilirubin is <3x ULN and the direct bilirubin is within normal limits
- Acceptable kidney function indicated by serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline)
- Acceptable hematologic status:
- Absolute neutrophil count ≥ 1000 cells/mm3,
- Platelet count ≥ 75,000 (plt/mm3) (CTCAE Grade 1 baseline)
- Hemoglobin ≥ 9.0 g/dL.
- Fasting blood glucose of <165mg/dL
- Urinalysis: no clinically significant abnormalities
- International normalized ratio (INR) ≤1.7
- Well-controlled blood pressure as determined by the treating investigator
- Patients requiring narcotic analgesics must be on stable doses for at least 2 weeks prior to study entry.
Who cannot join
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.
- Underlying psychiatric disorder requiring hospitalization within the last two years.
- Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.
- Active, uncontrolled bacterial, viral or fungal infection, requiring systemic therapy.
- Treatment with radiation therapy, surgery, or investigational therapy within 28 days prior to registration.
- Unwillingness or inability to comply with procedures required in this protocol.
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- Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator.
- Patients who are receiving coumadin, apixaban, argatroban or rivaroxaban. Patients who are receiving other drugs that are sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that cannot be stopped at least 7 days or 5 half-lives (whichever is longer) before starting treatment with opaganib may be treated on this study with careful monitoring for toxic effects or loss of efficacy of the relevant drug. A list of commonly used drugs that are sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes with the half-life of each drug identified, is included as an Appendix C.
- Patients who are currently participating in any other clinical trial of an investigational product.
- Other primary malignancy requiring systemic treatment within past 5 years except carcinoma in situ of the cervix or urinary bladder or non-melanoma skin cancer.
- Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator.
- Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Emory University
Atlanta, Georgia, 20322
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Phase II Study of the Addition of Opaganib to Androgen Antagonists in Patients With Prostate Cancer Progression on Enzalutamide or Abiraterone
This is a Phase II study of the investigational drug opaganib. Patients with metastatic castration resistant prostate cancer (mCRPC) who have experienced disease progression while receiving abiraterone or enzalutamide will receive Opaganib at either 250 mg or 500 mg by mouth twice a day continuously. Patients will continue on study drug until the development of progressive disease, intolerable toxicity, withdrawal of patient consent or other event as outlined in patient discontinuation.
- Conditions
- Prostate Cancer
- Being tested
- Opaganib, Abiraterone, Enzalutamide
- Keywords
- Yeliva, ABC294640, 103193
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OpaganibDrug
500mg of Opaganib orally twice a day continuously.
AbirateroneDrug
IV as directed by SOC
EnzalutamideDrug
IV as directed by SOC
OpaganibDrug
250mg of Opaganib orally twice a day continuously.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2: Opaganib with abiraterone | Experimental | Not described Receives: Drug: Opaganib; Drug: Abiraterone |
| Cohort 3: Opaganib with enzalutamide | Experimental | Not described Receives: Drug: Opaganib; Drug: Enzalutamide |
| Cohort 1a: Opaganib with abiraterone | Experimental | Not described Receives: Drug: Abiraterone; Drug: Opaganib |
| Cohort 1b: Opaganib with enzalutamide | Experimental | Not described Receives: Drug: Enzalutamide; Drug: Opaganib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Status
Stable disease or better according to Prostate Cancer Working Group 3 (PCWG3) criteria after four cycles of treatment
Measured: 113 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start27 Mar 2020
- Primary completion31 Aug 2023
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael Lilly, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207255
- Sponsor's protocol ID
- Pro00095537
- Other IDs
- 1P01CA203628-01, 103193
- Status last verified
- Sep 2024
- First submitted
- 25 Nov 2019
- Last updated
- 25 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brown JT, Nazha B, Ferreira AC, Armeson K, Hill EG, Ogretmen B, Mehrotra S, Brisendine A, Magrath G, Plasse TF, Gourdin TS, Kucuk O, Lilly M. Phase II Trial of Opaganib Addition in Metastatic Castration-Resistant Prostate Cancer After Disease Progression on Abiraterone or Enzalutamide. Cancer Med. 2026 Apr;15(4):e71633. doi: 10.1002/cam4.71633.
PubMed 41981710
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Addition of Opaganib to Androgen Antagonists in Patients With Prostate Cancer Progression on Enzalutamide or Abiraterone
- ClinicalTrials.gov ID
- NCT04207255
- Acronym / sponsor ID
- Pro00095537
- Conditions
- Prostate Cancer
- Keywords
- Yeliva, ABC294640, 103193
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Mar 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Posted 25 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II study of the investigational drug opaganib. Patients with metastatic castration resistant prostate cancer (mCRPC) who have experienced disease progression while receiving abiraterone or enzalutamide will receive Opaganib at either 250 mg or 500 mg by mouth twice a day continuously. Patients will continue on study drug until the development of progressive disease, intolerable toxicity, withdrawal of patient consent or other event as outlined in patient discontinuation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 2: Opaganib with abiraterone | Experimental | Drug: Opaganib, Drug: Abiraterone |
| Cohort 3: Opaganib with enzalutamide | Experimental | Drug: Opaganib, Drug: Enzalutamide |
| Cohort 1a: Opaganib with abiraterone | Experimental | Drug: Abiraterone, Drug: Opaganib |
| Cohort 1b: Opaganib with enzalutamide | Experimental | Drug: Enzalutamide, Drug: Opaganib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Patient must have mCRPC. Each patient must have:
- Voluntary, signed and dated, institutional review board (IRB)-approved informed consent form in accordance with regulatory and institutional guidelines.
- Documented progression during treatment with enzalutamide or abiraterone, as determined by the enrolling investigator.
- Testosterone level documented to be less than 50ng/
- 18 years of age or older.
Key exclusion criteria (12 listed)
- New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.
- Underlying psychiatric disorder requiring hospitalization within the last two years.
- Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.
- Active, uncontrolled bacterial, viral or fungal infection, requiring systemic therapy.
- Treatment with radiation therapy, surgery, or investigational therapy within 28 days prior to registration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opaganib500mg of Opaganib orally twice a day continuously. | Drug | Cohort 2: Opaganib with abiraterone, Cohort 3: Opaganib with enzalutamide |
| AbirateroneIV as directed by SOC | Drug | Cohort 1a: Opaganib with abiraterone, Cohort 2: Opaganib with abiraterone |
| EnzalutamideIV as directed by SOC | Drug | Cohort 1b: Opaganib with enzalutamide, Cohort 3: Opaganib with enzalutamide |
| Opaganib250mg of Opaganib orally twice a day continuously. | Drug | Cohort 1a: Opaganib with abiraterone, Cohort 1b: Opaganib with enzalutamide |
Primary outcome
Disease Control Status
Time frame: 113 days
Stable disease or better according to Prostate Cancer Working Group 3 (PCWG3) criteria after four cycles of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41981710Brown JT, Nazha B, Ferreira AC, Armeson K, Hill EG, Ogretmen B, Mehrotra S, Brisendine A, Magrath G, Plasse TF, Gourdin TS, Kucuk O, Lilly M. Phase II Trial of Opaganib Addition in Metastatic Castration-Resistant Prostate Cancer After Disease Progression on Abiraterone or Enzalutamide. Cancer Med. 2026 Apr;15(4):e71633. doi: 10.1002/cam4.71633.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Lilly, MD principal investigator
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Opaganib, Abiraterone and Enzalutamide in people with Prostate Cancer, run by Medical University of South Carolina at 2 sites in United States.
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 23 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 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Disease Control Status (time frame: 113 days). 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 NCT04207255, which also lists 1 linked publication.
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 25 Sep 2024.