Refractory CancerNCT06024603
Individualized Treatments in Adults With Relapsed/Refractory Cancers
A study testing Drug Sensitivity Test (DST) in people with Refractory Cancer and Relapsed Cancer, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
A personalized cancer medicine approach would address therapy resistance, cancer metastasis, and limited options after standard of care is exhausted in advanced cancer participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Cancer, Relapsed Cancer
- What is being tested?
- Drug Sensitivity Test (DST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Nov 2023to 31 Dec 2025
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 18 years or older at the time of enrollment on this study of any gender, race, or ethnicity.
- Patients with suspected or confirmed diagnosis of recurrent or refractory cancer with no curative treatment options.
- Participants who have undergone at least two lines of previous therapy.
- Participants who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers) or who have scheduled or recently had paracentesis or thoracentesis performed.
- Participants willing to have a blood draw or buccal swab done for the purposes of genetic testing.
- Participants willing to sign informed consent.
Who cannot join
- Participants who do not have malignant tissue available and accessible.
- Participants for whom the amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.
- Participants with newly diagnosed tumors and tumors that have high (>90%) cure rate with safe standard therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Florida International University
Miami, Florida, 33199
Lerner College of Medicine, Cleveland Clinic Florida
Weston, Florida, 33331
About this study
A personalized cancer medicine approach would address therapy resistance, cancer metastasis, and limited options after standard of care is exhausted in advanced cancer participants. This approach may reduce the barriers to approved therapeutic assignment currently limited to a particular cancer type or patient demographic.
Read the detailed description
Treatment itself will not be given as part of this trial. The results of the drug sensitivity test (DST) and genomic screening will be used to inform treating physician about participant-specific drug sensitivity or resistance guiding best therapy choices. The physician will decide the most appropriate treatment for each case, with the option to add one or more personalized (assay-guided) drug(s) from the investigational platform. All participants will need to be consented separately for any subsequent investigational treatment if no standard treatment options are available.
- Conditions
- Refractory Cancer, Relapsed Cancer
- Being tested
- Drug Sensitivity Test (DST)
- Medical subject headings
- Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug Sensitivity Test (DST)Diagnostic test
Refractory cancer tissue will be collected from participants and subjected to single-drug testing while DNA is simultaneously sent for targeted gene sequencing. Drug sensitivity scores from the tests will become available for a final list of therapeutic options ranked best in order of preference together with suggested doses and schedules.
| Study group | Role | What they receive |
|---|---|---|
| Drug Sensitivity Testing | Experimental | The results of the DST and genomic screening will be used to inform treating physician about participant-specific drug sensitivity or resistance guiding best therapy choices. The physician will decide which treatment will be most appropriate for each case. All participants will need to be consented separately for any subsequent investigational treatment if no standard treatment options are available. Receives: Diagnostic Test: Drug Sensitivity Test (DST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment recommendation feasibility
Primary objective is to determine feasibility of providing treatment recommendations to relapsed and refractory adult cancer patients based on ex vivo drug sensitivity testing (DST). Feasibility will be demonstrated if it is possible to recommend treatment within 4 weeks in at least 22 of 36 participants (62.5%).
Measured: Up to 4 weeks post-treatment
Treatment recommendation feasibility
Primary objective is to determine feasibility of providing treatment recommendations to relapsed and refractory adult cancer patients based on genomic profiling. Feasibility will be demonstrated if it is possible to recommend treatment within 4 weeks in at least 22 of 36 participants (62.5%).
Measured: Up to 4 weeks post-treatment
Secondary outcomes (3)
Treatment responsiveness
Treatment responsiveness will be measured by comparing individual outcomes of adult participants with relapsed and refractory cancers treated with DST-guided therapy to non-DST guided (conventional) therapy. To address this goal, the overall response rate will be calculated. A responder to the treatment will be defined as any patient who achieves a best response of "partial response" or "complete response" during the study period. Evaluable patients who demonstrate a complete or partial response confirmed by physician's review will be considered a responder. All other evaluable patients will be considered non- responder. Outcomes will be observed during treatment and follow-up for one year post-treatment or until disease progression, death, or withdrawal, whichever occurs first.
Measured: Up tp 1 year post-treatment
Progression-free survival
Progression-free survival will be measured by comparing individual outcomes of participants with relapsed and refractory cancers treated with DST-guided therapy to non-DST guided (conventional) therapy. DFS will be defined as time from start of treatment to even (treatment failure, relapse, second malignancy, death) or last follow-up for those who are event-free. Outcomes will be observed during treatment and follow-up for one year post-treatment or until disease progression, death, or withdrawal, whichever occurs first.
Measured: Up tp 1 year post-treatment
Progression-free survival ratio
We will assess changes in progression-free survival from each patient's previous treatment versus their progression-free survival from the treatment assigned during the trial. Assessments will be made both in the DST-guided cohort and the non-DST-guided (conventional) cohort. Analysis will include both the raw ratio as well as the number of incidences of 30% improved PFS on trial versus previous regimen (PFS2/PFS1 > 1.3x).
Measured: Up to 1 year post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start20 Nov 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Florida International University, Community Foundation of Broward
- Responsible party
- Sponsor
- Investigators
- Jorge Manrique-Succar, MD, Principal investigator, Lerner College of Medicine, Cleveland Clinic FloridaDiana Azzam, PhD, Principal investigator, Robert Stempel College of Public Health and Social Work, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06024603
- Sponsor's protocol ID
- CASE5Y22
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Treatments in Adults With Relapsed/Refractory Cancers
- ClinicalTrials.gov ID
- NCT06024603
- Acronym / sponsor ID
- CASE5Y22
- Conditions
- Refractory Cancer, Relapsed Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Florida International University, Community Foundation of Broward
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A personalized cancer medicine approach would address therapy resistance, cancer metastasis, and limited options after standard of care is exhausted in advanced cancer participants. This approach may reduce the barriers to approved therapeutic assignment currently limited to a particular cancer type or patient demographic.
Detailed description
Treatment itself will not be given as part of this trial. The results of the drug sensitivity test (DST) and genomic screening will be used to inform treating physician about participant-specific drug sensitivity or resistance guiding best therapy choices. The physician will decide the most appropriate treatment for each case, with the option to add one or more personalized (assay-guided) drug(s) from the investigational platform. All participants will need to be consented separately for any subsequent investigational treatment if no standard treatment options are available.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug Sensitivity Testing | Experimental | Diagnostic Test: Drug Sensitivity Test (DST)The results of the DST and genomic screening will be used to inform treating physician about participant-specific drug sensitivity or resistance guiding best therapy choices. The physician will decide which treatment will be most appropriate for each case. All participants will need to be consented separately for any subsequent investigational treatment if no standard treatment options are available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants aged 18 years or older at the time of enrollment on this study of any gender, race, or ethnicity.
- Patients with suspected or confirmed diagnosis of recurrent or refractory cancer with no curative treatment options.
- Participants who have undergone at least two lines of previous therapy.
- Participants who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers) or who have scheduled or recently had paracentesis or thoracentesis performed.
- Participants willing to have a blood draw or buccal swab done for the purposes of genetic testing.
Key exclusion criteria (3 listed)
- Participants who do not have malignant tissue available and accessible.
- Participants for whom the amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.
- Participants with newly diagnosed tumors and tumors that have high (>90%) cure rate with safe standard therapy.
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 |
|---|---|---|
| Drug Sensitivity Test (DST)Refractory cancer tissue will be collected from participants and subjected to single-drug testing while DNA is simultaneously sent for targeted gene sequencing. Drug sensitivity scores from the tests will become available for a final list of therapeutic options ranked best in order of preference together with suggested doses and schedules. | Diagnostic test | Drug Sensitivity Testing |
Primary outcome
Treatment recommendation feasibility
Time frame: Up to 4 weeks post-treatment
Primary objective is to determine feasibility of providing treatment recommendations to relapsed and refractory adult cancer patients based on ex vivo drug sensitivity testing (DST). Feasibility will be demonstrated if it is possible to recommend treatment within 4 weeks in at least 22 of 36 participants (62.5%).
Treatment recommendation feasibility
Time frame: Up to 4 weeks post-treatment
Primary objective is to determine feasibility of providing treatment recommendations to relapsed and refractory adult cancer patients based on genomic profiling. Feasibility will be demonstrated if it is possible to recommend treatment within 4 weeks in at least 22 of 36 participants (62.5%).
3 secondary outcomes
Treatment responsiveness
Time frame: Up tp 1 year post-treatment
Progression-free survival
Time frame: Up tp 1 year post-treatment
Progression-free survival ratio
Time frame: Up to 1 year post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
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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.
Jorge Manrique-Succar, MD principal investigator
Lerner College of Medicine, Cleveland Clinic Florida
Diana Azzam, PhD principal investigator
Robert Stempel College of Public Health and Social Work, Florida International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drug Sensitivity Test (DST) in people with Refractory Cancer and Relapsed Cancer, run by Case Comprehensive Cancer Center 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 6 inclusion and 3 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 6 Jul 2026. 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.
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?
Treatment recommendation feasibility (time frame: Up to 4 weeks post-treatment). 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?
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 6 Jul 2026.