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Prostate CancerPhase 1/2NCT06218667

A Study of Copanlisib in Combination with Degarelix in People with Prostate Cancer

A Phase 1/2 study testing Copanlisib, Degarelix and Radical Prostatectomy in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The researchers are doing this study to find out whether copanlisib in combination with degarelix, given before standard surgical treatment (radical prostatectomy), is a safe and effective treatment that causes few or mild side effects for people who have localized high-risk prostate cancer. 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?
Copanlisib, Degarelix and Radical Prostatectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
11 Jan 2024to Jan 2027
Phase
Phase 1/2
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

  • Willing and able to provide written informed consent and privacy authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed.
  • Individuals with prostate cancer 18 years of age and above
  • Histological or cytological evidence of prostate cancer
  • Documented high-risk localized prostate cancer based on one or more of the following NCCN criteria:
  • PSA >20ng/ml or
  • Gleason ≥8 or
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  • Clinical stage ≥cT3a
  • Known PTEN status:
  • PTEN loss by IHC for participants in the PTEN loss cohort
  • PTEN intact by IHC for participants in the exploratory PTEN intact cohort (only available if PTEN intact cohort is opened)
  • Candidate for RP as determined by treating physician
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix A: Performance Status Criteria)
  • Normal organ function with acceptable initial laboratory values within 28 days of registration:
  • ANC ≥ 1.5 K/mcL
  • Hemoglobin ≥ 9g/dL
  • Platelet count ≤100 K/mcL
  • Creatinine ≤ 1.5 x the institutional upper limit of normal (ULN)
  • Potassium within institutional normal range
  • Total Bilirubin ≤ 1.5 x ULN (Note: In participants with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, participant may be eligible)
  • SGOT (AST) ≤ 2.5 x ULN
  • SGPT (ALT) ≤ 2.5 x ULN
  • GFR (MDRD) ≥ 30 mL/min/1.73 m^2
  • Participants must agree to use a medically acceptable method of birth control (i.e., spermicide in conjunction with a barrier such as a condom) or sexual abstinence prior to registration, for the duration of study participation and for at least 5 months after the last treatment with copanlisib.

Who cannot join

  • Radiographic evidence of distant (extra-pelvic) metastatic prostate cancer on CT and/or MRI, bone scan or PET scan
  • On ADT (GnRH agonists or antagonists) for > 4 weeks at time of consent
  • Prior radiation to prostate
  • Medical conditions such as uncontrolled hypertension or cardiac disease that would, in the opinion of the investigator preclude participation in this protocol
  • A diagnosis of diabetes (type 1 or 2) on medications for the purpose of treating hyperglycemia or HgbA1C > 7 will be excluded from study
  • Any other active malignancy at time of first dose of study treatment or diagnosis of another malignancy within 3 years prior to first dose of study treatment that requires active treatment, except for basal or squamous cell skin cancer or superficial bladder cancer that has previously been treated.
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  • Use of any prohibited concomitant medications including herbal supplements Medications With the Potential for Drug-Drug Interactions) within 2 weeks prior to treatment start
  • Receiving any other investigational agents within 4 weeks or 5x the half-life of investigational agent (whichever is longer) from this study's treatment start
  • Known allergy to any of the compounds under investigation
  • Any other condition which, in the opinion of the Investigator, would preclude participation in this trial

About this study

Official title: CHARIOT: a Phase 1b/2 Study of Androgen Deprivation Therapy and Copanlisib in High-Risk Localized Prostate Cancer Patients Prior to Radical Prostatectomy

The researchers are doing this study to find out whether copanlisib in combination with degarelix, given before standard surgical treatment (radical prostatectomy), is a safe and effective treatment that causes few or mild side effects for people who have localized high-risk prostate cancer.

Conditions
Prostate Cancer
Being tested
Copanlisib, Degarelix, Radical Prostatectomy
Keywords
Androgen Deprivation Therapy, Copanlisib, Radical Prostatectomy, Degarelix
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • CopanlisibDrug

    Dose level 1 (starting dose): 45 mg of copanlisib IV weekly x 3 weeks on/1 week off Dose level 2 (standard dose): 60 mg of copanlisib IV weekly x 3 weeks on/1 week off

  • DegarelixDrug

    Degarelix (GnRH antagonist): 240 mg loading dose sub-cutaneous once on C1D1; 80 mg maintenance dose on C2D1 and C3D1.

  • Radical ProstatectomyProcedure or surgery

    Standard treatment

Study groups in NCT06218667
Study groupRoleWhat they receive
Copanlisib in Combination With DegarelixExperimentalPhase 1b: The starting Dose level 1 will be 45 mg with the intent of dose escalating to the standard dose of 60 mg approved for heme malignancy. In the event of > =2 DLT at Dose level 1 (45 mg) the study will be terminated. If >= 2 DLT in patients at Dose level 2 (60 mg), Dose level 1 (45 mg) will be the RP2D if <= 1 DLT out of 6 patients at this dose. Phase 2: Patients may dose reduce at the discretion of the investigator to the lowest dose of 45 mg. Participants who do not tolerate the copanlisib dose of 45 mg must discontinue study treatment permanently.
Receives: Drug: Copanlisib; Drug: Degarelix; Procedure: Radical Prostatectomy

What is being measured

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

  1. phase Ib determine the recommended phase 2 dose (RP2D) of copanlisib in combination with degarelix

    DLTs are any of the following events not clearly due to the underlying disease or extraneous causes. Toxicities will be evaluated using CTCAE version 5.0 (CTCAE v5.0). Only toxicities that meet DLT definitions within the DLT assessment window (one 28-day cycle) and are attributed to degarelix, copanlisib or copanlisib plus degarelix will be counted as DLTs.

    Measured: 1 year

  2. Phase 2 determine the rate of pCR or MRD at Radical Prostatectomy

    pCR will be defined as the absence of morphologically identifiable carcinoma in the RP specimen. MRD will be defined as ≤ 5mm of residual tumor in the RP specimen.

    Measured: 2 years

Timeline

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

  1. First posted23 Jan 2024
  2. Study start11 Jan 2024
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Why it stopped: Study drug not available per sponsor

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06218667
Sponsor's protocol ID
23-331
Status last verified
Oct 2024
First submitted
11 Jan 2024
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Copanlisib, Degarelix and Radical Prostatectomy in people with Prostate Cancer, run by Memorial Sloan Kettering Cancer Center.

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 10 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: withdrawn, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 was withdrawn before enrolling participants, so there are no results.

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?

phase Ib determine the recommended phase 2 dose (RP2D) of copanlisib in combination with degarelix (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT06218667.

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 31 Oct 2024.

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