Hematologic MalignancyPhase 1NCT03555955
A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351
A Phase 1 study testing CPX-351 in people with Hematologic Malignancy and Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 13 sites in 2 countries.
Trial summary
This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia
- What is being tested?
- CPX-351
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 20 Nov 2018to 26 May 2021
- Phase
- Phase 1
- 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
- Ability to understand and voluntarily give informed consent.
- Male or female patients, age ≥18 years at the time of consent.
- Diagnosis of hematologic malignancy including, but not limited to, AML, ALL, and MDS. Patients may be newly diagnosed, refractory to initial treatment, or in relapse.
- Patients with normal renal function, or moderate or severe renal impairment as categorized by creatinine clearance (CrCl)) using the Cockcroft-Gault Formula.
- Consent of female patients to use a medically acceptable method of contraception for at least 2 months prior to the first dose of CPX-351 and consent of female patients to use a medically acceptable method of contraception throughout the entire study period and for 6 months following the last dose of CPX-351.
- Male patients must be willing to refrain from sperm donation for 6 months following the last dose of CPX-351and must use adequate contraception throughout the entire study period and for 6 months following the last dose of CPX-351.
Who cannot join
- Prior treatment with CPX-351 ≤ to 1 month before the start of CPX-351 in this study.
- Patients with active (uncontrolled, metastatic) second malignancies are excluded.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent obtaining informed consent.
- Patients with known hypersensitivity to cytarabine, daunorubicin, or liposomal products.
- Female patients who are pregnant, nursing, or lactating.
- Participation in another clinical trial of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to enrollment in this study.
- Any other condition that would cause a risk to patients if they participate in the trial.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States11 sites
Northside Hospital - Blood and Bone Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342
Baylor University Medical Center
Dallas, Texas, 75246
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Weill Cornell Medical College
New York, New York, 10021
Oregon Health and Science University
Portland, Oregon, 97239
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
New York Medical/Westchester
Valhalla, New York, 10595
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
University of Kansas Cancer Center
Westwood, Kansas, 66205
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Canada2 sites
University Health Network/Princess Margaret Cancer Center
Toronto, Ontaro, M5G 1Z5
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: A Phase 1 Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351 (Daunorubicin and Cytarabine) Liposome for Injection Treatment in Adult Patients With Hematologic Malignancies
This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment.
- Conditions
- Hematologic Malignancy, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes
- Being tested
- CPX-351
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPX-351Drug
Also called Vyxeos™
CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
CPX-351Drug
Also called Vyxeos
CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Normal renal function Receives: Drug: CPX-351 |
| Cohort 2 | Experimental | Moderate renal impairment Receives: Drug: CPX-351 |
| Cohort 3 | Experimental | Severe renal impairment Receives: Drug: CPX-351 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of CPX-351
The key PK parameter AUCtau will be assessed
Measured: Blood samples will be collected during first induction on Day 1 predose, Day 5 predose, 45 and 90 minutes post infusion start, 2, 3, 4, 6, 8, 24, 48, 96, 168, and 216 hours post Day 5 infusion start.
Secondary outcomes (2)
PK parameter of the individual components of CPX-351, and their respective metabolites
The key PK parameter AUCtau will be assessed
Measured: Blood samples will be collected during first induction on Day 1 predose, Day 5 predose, 45 and 90 minutes post infusion start, 2, 3, 4, 6, 8, 24, 48, 96, 168, and 216 hours post Day 5 infusion start.
Incidence of Treatment Emergent Adverse Events (TEAEs)
TEAEs are defined as any AE starting after the initiation of the first infusion.
Measured: Up to 31 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start20 Nov 2018
- Primary completion26 May 2021
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555955
- Sponsor's protocol ID
- CPX351-102
- Status last verified
- Jul 2021
- First submitted
- 14 May 2018
- Last updated
- 22 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Solomon SR, Powell BL, Koprivnikar J, Lai C, Male H, Michaelis LC, Newell LF, Sanford D, Jenkins J, Zelaya A, Coppola S, Faderl S, Walter RB. CPX-351 Pharmacokinetics and Safety in Adults with Hematologic Malignancies and Renal Function Impairment: Phase 1 Trial. Cancers (Basel). 2024 Feb 24;16(5):915. doi: 10.3390/cancers16050915.
PubMed 38473278
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351 (Daunorubicin and Cytarabine) Liposome for Injection Treatment in Adult Patients With Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT03555955
- Acronym / sponsor ID
- CPX351-102
- Conditions
- Hematologic Malignancy, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 14 Jun 2018 (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.
This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: CPX-351Normal renal function |
| Cohort 2 | Experimental | Drug: CPX-351Moderate renal impairment |
| Cohort 3 | Experimental | Drug: CPX-351Severe renal impairment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ability to understand and voluntarily give informed consent.
- Male or female patients, age ≥18 years at the time of consent.
- Diagnosis of hematologic malignancy including, but not limited to, AML, ALL, and MDS. Patients may be newly diagnosed, refractory to initial treatment, or in relapse.
- Patients with normal renal function, or moderate or severe renal impairment as categorized by creatinine clearance (CrCl)) using the Cockcroft-Gault Formula.
- Consent of female patients to use a medically acceptable method of contraception for at least 2 months prior to the first dose of CPX-351 and consent of female patients to use a medically acceptable method of contraception throughout the entire study period and for 6 months following the last dose of CPX-351.
Key exclusion criteria (7 listed)
- Prior treatment with CPX-351 ≤ to 1 month before the start of CPX-351 in this study.
- Patients with active (uncontrolled, metastatic) second malignancies are excluded.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent obtaining informed consent.
- Patients with known hypersensitivity to cytarabine, daunorubicin, or liposomal products.
- Female patients who are pregnant, nursing, or lactating.
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 |
|---|---|---|
| CPX-351Also: Vyxeos™CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes. | Drug | Cohort 1 |
| CPX-351Also: VyxeosCPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes. | Drug | Cohort 2, Cohort 3 |
Primary outcome
Pharmacokinetics (PK) of CPX-351
Time frame: Blood samples will be collected during first induction on Day 1 predose, Day 5 predose, 45 and 90 minutes post infusion start, 2, 3, 4, 6, 8, 24, 48, 96, 168, and 216 hours post Day 5 infusion start.
The key PK parameter AUCtau will be assessed
2 secondary outcomes
PK parameter of the individual components of CPX-351, and their respective metabolites
Time frame: Blood samples will be collected during first induction on Day 1 predose, Day 5 predose, 45 and 90 minutes post infusion start, 2, 3, 4, 6, 8, 24, 48, 96, 168, and 216 hours post Day 5 infusion start.
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 31 months.
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 22 Jul 2021.
- Derived from this study: PubMed 38473278Solomon SR, Powell BL, Koprivnikar J, Lai C, Male H, Michaelis LC, Newell LF, Sanford D, Jenkins J, Zelaya A, Coppola S, Faderl S, Walter RB. CPX-351 Pharmacokinetics and Safety in Adults with Hematologic Malignancies and Renal Function Impairment: Phase 1 Trial. Cancers (Basel). 2024 Feb 24;16(5):915. doi: 10.3390/cancers16050915.
Related trials for Hematologic Malignancy
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
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.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPX-351 in people with Hematologic Malignancy and Acute Myeloid Leukemia, run by Jazz Pharmaceuticals at 13 sites in 2 countries.
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 7 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 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Canada. 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 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.
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 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?
Pharmacokinetics (PK) of CPX-351 (time frame: Blood samples will be collected during first induction on Day 1 predose, Day 5 predose, 45 and 90 minutes post infusion start, 2, 3, 4, 6, 8, 24, 48, 96, 168, and 216 hours post Day 5 infusion start.). 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 NCT03555955, 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 22 Jul 2021.