Lymphoma, Non-HodgkinPhase 1BRiMNCT02257242

Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma

A Phase 1 study testing Rituximab, Bendamustine and Vincristine sulfate liposome injection in people with Lymphoma, Non-Hodgkin and Lymphoma, Follicular, run by Brown University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates addition of Vincristine Sulfate Liposome Injection (Marqibo®) to the standard regimen of Bendamustine and Rituximab in adult patients with indolent B-cell lymphoma. This is a dose-escalation study. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Mantle-Cell
What is being tested?: Rituximab, Bendamustine and Vincristine sulfate liposome injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 10 May 2017to 18 Nov 2020
Phase: Phase 1
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed indolent B-cell non-Hodgkin lymphoma.
Radiological measurable disease.
Previous treatment for lymphoma is allowed, with the exception of use of bendamustine within 6 months or any prior use of vincristine sulfate liposome injection
Eastern Cooperative Oncology Group performance status 0 or 1;
Life expectancy of at least 6 months;
Adequate organ and marrow function;
Women of child-bearing potential and men must agree to use adequate contraception.
Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

History of allergic reactions attributed to any drug used in the study.
Any lymphoma-directed therapy within 4 weeks.
Any prior treatment with vincristine sulfate liposome injection.
Prior treatment with bendamustine or vincristine sulfate within 180 days of enrollment.
Patients who are receiving any other investigational agents with the exception of endocrine therapy for breast or prostate cancer.
Central nervous system involvement.

Show all 15Show fewer

Peripheral sensory or motor neuropathy.
History of a demyelinating condition.
Positive test for the Human Anti-Chimeric Antibody (HACA).
Patients receiving any medications or substances that are strong inhibitors or inducers of Cytochrome P450, family 3, subfamily A (CYP3A) enzyme are ineligible.
Uncontrolled intercurrent illness.
Prisoners.
Pregnant or breast-feeding women.
Known Human Immunodeficiency Virus (HIV) or active Hepatitis B infection
Any prior or active cancer, which in the opinion of the investigator would preclude safe participation in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Rhode Island Hospital and The Miriam Hospital
Providence, Rhode Island, 02903

Other trials in United States

About this study

Official title: BrUOG 326: A Phase I Dose-Escalation Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With Bendamustine and Rituximab (BRiM) in Indolent Non-Hodgkin Lymphoma

Read the detailed description

Bendamustine-rituximab is a standard chemotherapy regimen for treatment of many indolent B-cell lymphomas, but most patients experience a recurrence of the lymphoma. Vincristine sulfate has been a traditional component of chemotherapy regimens in non-Hodgkin lymphoma and it is possible that adding it to the bendamustine-rituximab regimen might provide a better quality of remissions or longer duration of remissions with acceptable toxicity.

This is a phase 1, single-center, open-label, single-arm trial in patients with indolent B-cell non-Hodgkin lymphoma otherwise appropriate for bendamustine-rituximab as initial or subsequent line of therapy. Patients will receive the of rituximab and bendamustine in combination with escalating doses of vincristine sulfate liposome injection (Marqibo®). The objective of this study is to assess safety of this combination by establishing the maximum tolerated dose of vincristine sulfate liposome injection (Marqibo®) in the combination.

Conditions: Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, Small-Cell, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone
Being tested: Rituximab, Bendamustine, Vincristine sulfate liposome injection
Keywords: Bendamustine, Rituximab, Vincristine sulfate, Vincristine sulfate liposome injection, Phase I, Escalation With Overdose Control
Medical subject headings: Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone

What participants receive

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

RituximabDrug
Also called Rituxan, anti-CD20 antibody
375 mg/m2 I.V. on Day 1 of each cycle
BendamustineDrug
Also called Treanda
90 mg/m2 I.V. on Day 1 and 2 of each cycle
Vincristine sulfate liposome injectionDrug
Also called Marqibo
Dose per dose escalation protocol, I.V. on Day 2 of each cycle

Study groups in NCT02257242
Study group	Role	What they receive
Vincristine sulfate liposome injection 1.8 mg/m^2	Experimental	Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Receives: Drug: Rituximab; Drug: Bendamustine; Drug: Vincristine sulfate liposome injection
Vincristine sulfate liposome injection 1.95 mg/m^2	Experimental	Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Receives: Drug: Rituximab; Drug: Bendamustine; Drug: Vincristine sulfate liposome injection
Vincristine sulfate liposome injection 1.98 mg/m^2	Experimental	Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Receives: Drug: Rituximab; Drug: Bendamustine; Drug: Vincristine sulfate liposome injection
Vincristine sulfate liposome injection 2.04 mg/m^2	Experimental	Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Receives: Drug: Rituximab; Drug: Bendamustine; Drug: Vincristine sulfate liposome injection
Vincristine sulfate liposome injection 2.10 mg/m^2	Experimental	Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Receives: Drug: Rituximab; Drug: Bendamustine; Drug: Vincristine sulfate liposome injection
Vincristine sulfate liposome injection 2.14 mg/m^2	Experimental	Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Receives: Drug: Rituximab; Drug: Bendamustine; Drug: Vincristine sulfate liposome injection
Vincristine sulfate liposome injection 2.19 mg/m^2	Experimental	Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Receives: Drug: Rituximab; Drug: Bendamustine; Drug: Vincristine sulfate liposome injection
Vincristine sulfate liposome injection 2.22 mg/m^2	Experimental	Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Receives: Drug: Rituximab; Drug: Bendamustine; Drug: Vincristine sulfate liposome injection
Vincristine sulfate liposome injection 2.24 mg/m^2	Experimental	Treatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy. Receives: Drug: Rituximab; Drug: Bendamustine; Drug: Vincristine sulfate liposome injection

What is being measured

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

Maximum Tolerated Dose
Determined as the median of the marginal posterior distribution using data from all available patients
Measured: Up to 6 cycles of treatment (approximately 6 months)

Secondary outcomes (3)

Number of Participants Who Completed Six Cycles of Study Treatment
Measured: Up to 6 cycles of treatment (approximately 6 months)
Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: Up to 6 cycles of treatment (approximately 6 months)
Complete Response Rate
The number of patients achieving complete response during treatment on study
Measured: Up to 6 cycles of treatment (approximately 6 months)

Timeline

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

10 May 201718 Nov 2020

First posted6 Oct 2014 (estimated)
Study start10 May 2017
Primary completion22 Aug 2020
Study completion18 Nov 2020

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 Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
More trials run by Brown UniversityThe 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: Randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02257242
Sponsor's protocol ID: BrUOG 326
Acronym: BRiM
Status last verified: May 2022
First submitted: 30 Sep 2014
Last updated: 9 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ollila T, Butera J, Egan P, Reagan J, Thomas A, Yakirevich I, MacKinnon K, Margolis J, McMahon J, Rosati V, Olszewski AJ. Vincristine Sulfate Liposome Injection with Bendamustine and Rituximab as First-Line Therapy for B-Cell Lymphomas: A Phase I Study. Oncologist. 2022 Jul 5;27(7):532-e542. doi: 10.1093/oncolo/oyab079.
PubMed 35641232

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BrUOG 326: A Phase I Dose-Escalation Study of Vincristine Sulfate Liposome Injection (Marqibo®) in Combination With Bendamustine and Rituximab (BRiM) in Indolent Non-Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT02257242
Acronym / sponsor ID: BRiM / BrUOG 326
Conditions: Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, Small-Cell, Waldenstrom Macroglobulinemia, Lymphoma, B-Cell, Marginal Zone
Keywords: Bendamustine, Rituximab, Vincristine sulfate, Vincristine sulfate liposome injection, Phase I, Escalation With Overdose Control
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Brown UniversityUniversity, hospital or other
Collaborators: Spectrum Pharmaceuticals, Inc, Rhode Island Hospital, The Miriam Hospital
Study start: 10 May 2017 (actual)
Primary completion: 22 Aug 2020 (actual)
Study completion: 18 Nov 2020 (actual)
First posted: 6 Oct 2014 (estimated)
Results: Posted 9 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Vincristine sulfate liposome injection 1.8 mg/m^2	Experimental	Drug: Rituximab, Drug: Bendamustine, Drug: Vincristine sulfate liposome injectionTreatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Vincristine sulfate liposome injection 1.95 mg/m^2	Experimental	Drug: Rituximab, Drug: Bendamustine, Drug: Vincristine sulfate liposome injectionTreatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Vincristine sulfate liposome injection 1.98 mg/m^2	Experimental	Drug: Rituximab, Drug: Bendamustine, Drug: Vincristine sulfate liposome injectionTreatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Vincristine sulfate liposome injection 2.04 mg/m^2	Experimental	Drug: Rituximab, Drug: Bendamustine, Drug: Vincristine sulfate liposome injectionTreatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Vincristine sulfate liposome injection 2.10 mg/m^2	Experimental	Drug: Rituximab, Drug: Bendamustine, Drug: Vincristine sulfate liposome injectionTreatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Vincristine sulfate liposome injection 2.14 mg/m^2	Experimental	Drug: Rituximab, Drug: Bendamustine, Drug: Vincristine sulfate liposome injectionTreatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Vincristine sulfate liposome injection 2.19 mg/m^2	Experimental	Drug: Rituximab, Drug: Bendamustine, Drug: Vincristine sulfate liposome injectionTreatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Vincristine sulfate liposome injection 2.22 mg/m^2	Experimental	Drug: Rituximab, Drug: Bendamustine, Drug: Vincristine sulfate liposome injectionTreatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.
Vincristine sulfate liposome injection 2.24 mg/m^2	Experimental	Drug: Rituximab, Drug: Bendamustine, Drug: Vincristine sulfate liposome injectionTreatment with the combination of rituximab, bendamustine and vincristine sulfate liposome injection will be repeated every 4 weeks for a maximum of 6 cycles. Dose-limiting toxicities will be evaluated during the first cycle of therapy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Histologically confirmed indolent B-cell non-Hodgkin lymphoma.
Radiological measurable disease.
Previous treatment for lymphoma is allowed, with the exception of use of bendamustine within 6 months or any prior use of vincristine sulfate liposome injection
Eastern Cooperative Oncology Group performance status 0 or 1;
Life expectancy of at least 6 months;

Key exclusion criteria (15 listed)

History of allergic reactions attributed to any drug used in the study.
Any lymphoma-directed therapy within 4 weeks.
Any prior treatment with vincristine sulfate liposome injection.
Prior treatment with bendamustine or vincristine sulfate within 180 days of enrollment.
Patients who are receiving any other investigational agents with the exception of endocrine therapy for breast or prostate cancer.

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
RituximabAlso: Rituxan, anti-CD20 antibody375 mg/m2 I.V. on Day 1 of each cycle	Drug	Vincristine sulfate liposome injection 1.8 mg/m^2, Vincristine sulfate liposome injection 1.95 mg/m^2, Vincristine sulfate liposome injection 1.98 mg/m^2, Vincristine sulfate liposome injection 2.04 mg/m^2, Vincristine sulfate liposome injection 2.10 mg/m^2, Vincristine sulfate liposome injection 2.14 mg/m^2, Vincristine sulfate liposome injection 2.19 mg/m^2, Vincristine sulfate liposome injection 2.22 mg/m^2, Vincristine sulfate liposome injection 2.24 mg/m^2
BendamustineAlso: Treanda90 mg/m2 I.V. on Day 1 and 2 of each cycle	Drug	Vincristine sulfate liposome injection 1.8 mg/m^2, Vincristine sulfate liposome injection 1.95 mg/m^2, Vincristine sulfate liposome injection 1.98 mg/m^2, Vincristine sulfate liposome injection 2.04 mg/m^2, Vincristine sulfate liposome injection 2.10 mg/m^2, Vincristine sulfate liposome injection 2.14 mg/m^2, Vincristine sulfate liposome injection 2.19 mg/m^2, Vincristine sulfate liposome injection 2.22 mg/m^2, Vincristine sulfate liposome injection 2.24 mg/m^2
Vincristine sulfate liposome injectionAlso: MarqiboDose per dose escalation protocol, I.V. on Day 2 of each cycle	Drug	Vincristine sulfate liposome injection 1.8 mg/m^2, Vincristine sulfate liposome injection 1.95 mg/m^2, Vincristine sulfate liposome injection 1.98 mg/m^2, Vincristine sulfate liposome injection 2.04 mg/m^2, Vincristine sulfate liposome injection 2.10 mg/m^2, Vincristine sulfate liposome injection 2.14 mg/m^2, Vincristine sulfate liposome injection 2.19 mg/m^2, Vincristine sulfate liposome injection 2.22 mg/m^2, Vincristine sulfate liposome injection 2.24 mg/m^2

Primary outcome

Maximum Tolerated Dose
Time frame: Up to 6 cycles of treatment (approximately 6 months)
Determined as the median of the marginal posterior distribution using data from all available patients

3 secondary outcomes

Number of Participants Who Completed Six Cycles of Study Treatment
Time frame: Up to 6 cycles of treatment (approximately 6 months)
Response Rate
Time frame: Up to 6 cycles of treatment (approximately 6 months)
Complete Response Rate
Time frame: Up to 6 cycles of treatment (approximately 6 months)

Results and safety

Results posted to the registry on 9 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vincristine Sulfate Liposome Injection: 1.8 mg/m^2	2	1
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2	1	1
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2	1	1
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2	2	2
Vincristine Sulfate Liposome Injection: 2.10 mg/m^2	1	1
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2	1	1
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2	1	1
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2	1	1
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2	1	1

Primary outcome: Maximum Tolerated Dose

Time frame: Up to 6 cycles of treatment (approximately 6 months). Number. Unit: mg/m^2

Measure	Dose-escalation Cohort n = 10
Value	2.24

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected from the date the subject signed the informed consent form for the trail until the end of study visit, approximately 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vincristine Sulfate Liposome Injection: 1.8 mg/m^2	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Vincristine Sulfate Liposome Injection: 1.95 mg/m^2	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Vincristine Sulfate Liposome Injection: 1.98 mg/m^2	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Vincristine Sulfate Liposome Injection: 2.04 mg/m^2	1 of 2 (50%)	2 of 2 (100%)	0 of 2
Vincristine Sulfate Liposome Injection: 2.1 mg/m^2	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Vincristine Sulfate Liposome Injection: 2.14 mg/m^2	1 of 1 (100%)	1 of 1 (100%)	0 of 1
Vincristine Sulfate Liposome Injection: 2.19 mg/m^2	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Vincristine Sulfate Liposome Injection: 2.22 mg/m^2	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Vincristine Sulfate Liposome Injection: 2.24 mg/m^2	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35641232Ollila T, Butera J, Egan P, Reagan J, Thomas A, Yakirevich I, MacKinnon K, Margolis J, McMahon J, Rosati V, Olszewski AJ. Vincristine Sulfate Liposome Injection with Bendamustine and Rituximab as First-Line Therapy for B-Cell Lymphomas: A Phase I Study. Oncologist. 2022 Jul 5;27(7):532-e542. doi: 10.1093/oncolo/oyab079.
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.

Adam J Olszewski, MD principal investigator

Rhode Island Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 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 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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?

Yes. Results are posted in the registry (first posted 9 Feb 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?

Maximum Tolerated Dose (time frame: Up to 6 cycles of treatment (approximately 6 months)). 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 NCT02257242, 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 9 Feb 2023.