Relapsed or Refractory Solid Tumors or Lymphoma in ChildrenPhase 1/2NCT03458728
Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients
A Phase 1/2 study testing Copanlisib (BAY806946) in people with Relapsed or Refractory Solid Tumors or Lymphoma in Children and Neuroblastoma, run by Bayer at 14 sites in United States.
Trial summary
This study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy. Read more about this study
- Who is it for?
- Ages 6 months to 21 years
- Conditions the study is for
- Relapsed or Refractory Solid Tumors or Lymphoma in Children, Neuroblastoma, Osteosarcoma
- What is being tested?
- Copanlisib (BAY806946)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 14 sitesUnited States
- Study dates
- 30 Apr 2018to 1 Feb 2023
- Phase
- Phase 1/2
- 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 6 months to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Signed informed consent form by patients and/or patients' parents/legal guardians and age appropriate assent form by the patients obtained before any study specific procedure
- Male or female patients from 6 months to ≤ 21 years old at the time of study enrollment
- Confirmation of diagnosis:
- Phase I: Patients must have histologic verification of a solid tumor or lymphoma malignancy at diagnosis, with measurable or evaluable disease, for which there is no standard curative anti-cancer treatment or treatment is no longer effective and must have received ≥ 1 prior line of therapy.
- Phase II: patients must have histologically verified tumor at initial diagnosis and radiologically or histologically confirmed status at inclusion as indicated in the following: neuroblastoma, osteosarcoma, rhabdomyosarcoma or Ewing sarcoma.
- Patients with solid tumors must have measurable disease (evaluable disease is acceptable for neuroblastoma and Ewing sarcoma). Tumor assessment will be done via computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography-computed tomography (PET-CT). Tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion. Bone scans (if clinically indicated) should be obtained within ≤ 4 weeks prior to the start of treatment.
- Performance level: Lansky ≥ 50% for patients ≤ 16 years of age and Karnofsky ≥ 50% for patients > 16 years of age.
- Adequate bone marrow, renal and liver function.
Who cannot join
- Active or uncontrolled infection (National Cancer Institute (NCI)-CTCAE Grade ≥ 2).
- History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).
- Diabetes mellitus.
- Uncontrolled arterial hypertension despite optimal medical management (per institutional guidelines).
- Patients with central nervous system (CNS) malignancies.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
The Children's Hospital
Aurora, Colorado, 80045
Children's Hospital of Alabama
Birmingham, Alabama, 35233
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, 45229
Texas Children's Hospital
Houston, Texas, 77030
Riley Hospital For Children
Indianapolis, Indiana, 46202
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Columbia University Medical Center
New York, New York, 10032
Children's Hospital of Orange County
Orange, California, 92868-3974
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Seattle Children's Hospital
Seattle, Washington, 98105
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
About this study
Official title: A Non-randomized, Open-label, Multi-center, Phase I/II Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Copanlisib in Pediatric Patients With Relapsed/Refractory Solid Tumors or Lymphoma
This study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.
- Conditions
- Relapsed or Refractory Solid Tumors or Lymphoma in Children, Neuroblastoma, Osteosarcoma, Rhabdomyosarcoma, Ewing Sarcoma
- Being tested
- Copanlisib (BAY806946)
- Keywords
- Phase I: relapsed or refractory solid tumors or lymphoma, Phase II: relapsed or refractory solid tumors (neuroblastoma, osteosarcoma, rhabdomyosarcoma or Ewing sarcoma)
- Medical subject headings
- Recurrence, Neuroblastoma, Osteosarcoma, Rhabdomyosarcoma, Sarcoma, Ewing, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Copanlisib (BAY806946)Drug
Copanlisib will be dosed on Day 1, Day 8, and Day 15 of every 28-day cycle. Phase 1: 2 or 3 dose cohorts may be evaluated in phase 1 of the study. Phase 2: RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation of BAY806946 in Phase 1 | Experimental | It is estimated that 2 or 3 dose cohorts may be evaluated in phase 1 of the study. Safety and MTD/RP2D dose will be evaluated in 2 age groups (< 1 year old and ≥ 1 year old). Receives: Drug: Copanlisib (BAY806946) |
| Patients with Neuroblastoma in Phase 2 | Experimental | Recommended Phase 2 dose (RP2D) for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. Receives: Drug: Copanlisib (BAY806946) |
| Patients with Osteosarcoma in Phase 2 | Experimental | RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. Receives: Drug: Copanlisib (BAY806946) |
| Patients with Rhabdomyosarcoma in Phase 2 | Experimental | RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. Receives: Drug: Copanlisib (BAY806946) |
| Patients with Ewing sarcoma in Phase 2 | Experimental | RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. Receives: Drug: Copanlisib (BAY806946) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: The Maximum Tolerated Dose (MTD): the Highest Dose Level of Copanlisib That Can be Given so That Not More Than 1 Out of 6 Patients Experience a DLT During the DLT Evaluation Period.
Maximum tolerated dose (MTD) for copanlisib was defined as the highest dose level where 6 patients have been treated and ≤ 1 participant experienced a DLT. This endpoint was performed on SAF.
Measured: Cycle 1 (28 days)
Phase 1: Number of Subjects With Dose Limiting Toxicity (DLT)
DLT was observed during first cycle of treatment, and assessed as possibly, probably or definitely related to treatment with copanlisib. The DLT observation period for the purposes of dose-escalation was the first cycle of therapy.
Measured: Cycle 1 (28 days)
Phase 1: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
TEAE was defined as any event arising or worsening after start of study drug administration until 30 days after the last dose of the study drug intake (end of safety follow-up).
This endpoint was performed on SAF.
Measured: After the first study intervention up to 30 days after the last dose of the study drug intake (end of safety follow up), with a maximum of 145 days.
Phase 1: Number of Subjects With Serious Adverse Events (SAEs)
This endpoint was performed on SAF.
Measured: Up to 150 days.
Phase 1: Number of Participants With Treatment-related Adverse Events (AEs).
This endpoint was performed on SAF.
Measured: Up to 145 days.
Phase 2: Objective Response Rate (ORR)
ORR was defined separately in each indication, as the number of responders divided by the number of subjects in FAS in the indication.
Measured: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Phase 2: Disease Control Rate (DCR)
The DCR was defined as the number of subjects with disease control divided by the number of subjects in FAS or per protocol set (PPS) in the indication.
Measured: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Phase 2: Progression-free Survival (PFS)
Measured: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Secondary outcomes (9)
Phase 1: Copanlisib Maximum Drug Concentration (Cmax)
Cmax: maximum concentration after the 3rd dose in a sequence of 3 nominal doses of copanlisib.
PK analysis set: All participants with at least one intake of study drug and with at least one valid measurement for copanlisib were included in the copanlisib PK analysis.
Measured: Age ≥ 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25 hour (h), 1.5- 3h, 22-24h). Age < 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25h, 22-24h). Cycle length is 28 days.
Phase 1: Area Under the Curve (AUC(0-168))
AUC(0-168): Area under the concentration-time curve [AUC] from 0 to 168 hours after the 3rd dose in a sequence of 3 nominal doses of copanlisib.
PK analysis set: All participants with at least one intake of study drug and with at least one valid measurement for copanlisib were included in the copanlisib PK analysis.
Measured: Age ≥ 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25 hour (h), 1.5- 3h, 22-24h). Age < 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25h, 22-24h). Cycle length is 28 days.
Phase 1: Objective Response Rate (ORR)
ORR by dose cohort is defined as the number of responders divided by the number of subjects in FAS in the indication.
The analysis of ORR was performed on FAS.
Measured: Up to 150 days
Phase 2: Duration of Response (DOR)
Measured: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Phase 2: PFS in Each Indication Except for Osteosarcoma
Measured: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Phase 2: Overall Survival (OS)
Measured: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Phase 2: Number of Participants With Treatment-emergent AEs
Measured: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Phase 2: Number of Subjects With Treatment Emergent SAEs
Measured: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Phase 2: Number of Subjects With Treatment-emergent Clinically Significant Change in Laboratory Parameters, ECGs and Vital Signs
Measured: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start30 Apr 2018
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Why it stopped: no anticipated benefit over available standard therapies
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.
- Other trials for Relapsed or Refractory Solid Tumors or Lymphoma in ChildrenStudies of the same condition, open and under way.
- More trials run by BayerThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458728
- Sponsor's protocol ID
- 19176
- Other IDs
- 2017-000383-15, 2017
- Status last verified
- Nov 2023
- First submitted
- 19 Feb 2018
- Last updated
- 4 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Open-label, Multi-center, Phase I/II Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Copanlisib in Pediatric Patients With Relapsed/Refractory Solid Tumors or Lymphoma
- ClinicalTrials.gov ID
- NCT03458728
- Acronym / sponsor ID
- 19176
- Conditions
- Relapsed or Refractory Solid Tumors or Lymphoma in Children, Neuroblastoma, Osteosarcoma, Rhabdomyosarcoma, Ewing Sarcoma
- Keywords
- Phase I: relapsed or refractory solid tumors or lymphoma, Phase II: relapsed or refractory solid tumors (neuroblastoma, osteosarcoma, rhabdomyosarcoma or Ewing sarcoma)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no anticipated benefit over available standard therapies
- Enrolment
- 31 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Posted 4 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose escalation of BAY806946 in Phase 1 | Experimental | Drug: Copanlisib (BAY806946)It is estimated that 2 or 3 dose cohorts may be evaluated in phase 1 of the study. Safety and MTD/RP2D dose will be evaluated in 2 age groups (< 1 year old and ≥ 1 year old). |
| Patients with Neuroblastoma in Phase 2 | Experimental | Drug: Copanlisib (BAY806946)Recommended Phase 2 dose (RP2D) for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. |
| Patients with Osteosarcoma in Phase 2 | Experimental | Drug: Copanlisib (BAY806946)RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. |
| Patients with Rhabdomyosarcoma in Phase 2 | Experimental | Drug: Copanlisib (BAY806946)RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. |
| Patients with Ewing sarcoma in Phase 2 | Experimental | Drug: Copanlisib (BAY806946)RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. |
Who may qualify
- Ages
- 6 months to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Signed informed consent form by patients and/or patients' parents/legal guardians and age appropriate assent form by the patients obtained before any study specific procedure
- Male or female patients from 6 months to ≤ 21 years old at the time of study enrollment
- Confirmation of diagnosis:
- Performance level: Lansky ≥ 50% for patients ≤ 16 years of age and Karnofsky ≥ 50% for patients > 16 years of age.
- Adequate bone marrow, renal and liver function.
Key exclusion criteria (5 listed)
- Active or uncontrolled infection (National Cancer Institute (NCI)-CTCAE Grade ≥ 2).
- History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).
- Diabetes mellitus.
- Uncontrolled arterial hypertension despite optimal medical management (per institutional guidelines).
- Patients with central nervous system (CNS) malignancies.
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 |
|---|---|---|
| Copanlisib (BAY806946)Copanlisib will be dosed on Day 1, Day 8, and Day 15 of every 28-day cycle. Phase 1: 2 or 3 dose cohorts may be evaluated in phase 1 of the study. Phase 2: RP2D for copanlisib in pediatric patients, as defined in the Phase I part of the study, will be used. | Drug | Dose escalation of BAY806946 in Phase 1, Patients with Ewing sarcoma in Phase 2, Patients with Neuroblastoma in Phase 2, Patients with Osteosarcoma in Phase 2, Patients with Rhabdomyosarcoma in Phase 2 |
Primary outcome
Phase 1: The Maximum Tolerated Dose (MTD): the Highest Dose Level of Copanlisib That Can be Given so That Not More Than 1 Out of 6 Patients Experience a DLT During the DLT Evaluation Period.
Time frame: Cycle 1 (28 days)
Maximum tolerated dose (MTD) for copanlisib was defined as the highest dose level where 6 patients have been treated and ≤ 1 participant experienced a DLT. This endpoint was performed on SAF.
Phase 1: Number of Subjects With Dose Limiting Toxicity (DLT)
Time frame: Cycle 1 (28 days)
DLT was observed during first cycle of treatment, and assessed as possibly, probably or definitely related to treatment with copanlisib. The DLT observation period for the purposes of dose-escalation was the first cycle of therapy.
Phase 1: Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Time frame: After the first study intervention up to 30 days after the last dose of the study drug intake (end of safety follow up), with a maximum of 145 days.
TEAE was defined as any event arising or worsening after start of study drug administration until 30 days after the last dose of the study drug intake (end of safety follow-up). This endpoint was performed on SAF.
Phase 1: Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Up to 150 days.
This endpoint was performed on SAF.
Phase 1: Number of Participants With Treatment-related Adverse Events (AEs).
Time frame: Up to 145 days.
This endpoint was performed on SAF.
Phase 2: Objective Response Rate (ORR)
Time frame: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
ORR was defined separately in each indication, as the number of responders divided by the number of subjects in FAS in the indication.
Phase 2: Disease Control Rate (DCR)
Time frame: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
The DCR was defined as the number of subjects with disease control divided by the number of subjects in FAS or per protocol set (PPS) in the indication.
Phase 2: Progression-free Survival (PFS)
Time frame: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
9 secondary outcomes
Phase 1: Copanlisib Maximum Drug Concentration (Cmax)
Time frame: Age ≥ 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25 hour (h), 1.5- 3h, 22-24h). Age < 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25h, 22-24h). Cycle length is 28 days.
Phase 1: Area Under the Curve (AUC(0-168))
Time frame: Age ≥ 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25 hour (h), 1.5- 3h, 22-24h). Age < 6 years: Pre-dose, Post-dose on Cycle 1 Day 1 and Day 15 (1-1.25h, 22-24h). Cycle length is 28 days.
Phase 1: Objective Response Rate (ORR)
Time frame: Up to 150 days
Phase 2: Duration of Response (DOR)
Time frame: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Phase 2: PFS in Each Indication Except for Osteosarcoma
Time frame: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Phase 2: Overall Survival (OS)
Time frame: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Phase 2: Number of Participants With Treatment-emergent AEs
Time frame: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Phase 2: Number of Subjects With Treatment Emergent SAEs
Time frame: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Phase 2: Number of Subjects With Treatment-emergent Clinically Significant Change in Laboratory Parameters, ECGs and Vital Signs
Time frame: Data was not collected for this endpoint due to study was terminated before the initiation of phase 2.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Copanlisib (BAY806946) in people with Relapsed or Refractory Solid Tumors or Lymphoma in Children and Neuroblastoma, run by Bayer at 14 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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 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?
Yes. Results are posted in the registry (first posted 4 Dec 2023). 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?
Phase 1: The Maximum Tolerated Dose (MTD): the Highest Dose Level of Copanlisib That Can be Given so That Not More Than 1 Out of 6 Patients Experience a DLT During the DLT Evaluation Period. (time frame: Cycle 1 (28 days)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2023.