Multiple MyelomaPhase 1/2NCT01496118

Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma

A Phase 1/2 study testing panobinostat and carfilzomib in people with Multiple Myeloma, run by SCRI Development Innovations, LLC at 13 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: panobinostat and carfilzomib
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 13 sitesUnited States
Study dates: Dec 2011to Dec 2020
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Eligible participants must have multiple myeloma using standard criteria.
Patients must have measurable disease requiring systemic therapy defined as at least one of the following:
Serum M-protein ≥1 g/dl (≥10 g/l)
Urine M-protein ≥200 mg/24 hrs
Serum free light chain assay: involved free light chain level ≥10 mg/dl (≥100 mg/l) provided the serum free light chain ratio is abnormal
Must have progressed during or after at least one previous bortezomib-containing treatment regimen. Patients who have received previous high-dose therapy/autologous stem cell transplantation are eligible.

Show all 21Show fewer

Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Must meet the following laboratory criteria:
Absolute neutrophil count (ANC) ≥1000/μL;
Platelets ≥70,000/microL;
AST or ALT and alkaline phosphatase (ALP) must be ≤ 2.5 x ULN, or ≤ 5 x ULN in patients with plasmacytomas of the liver;
Total bilirubin ≤ 1.5 x the institutional ULN;
Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 50 ml/min;
Serum potassium, calcium, magnesium WNL (These may be corrected prior to starting therapy, to make the patient eligible.)
Ability to swallow oral medications.
Baseline MUGA or ECHO must demonstrate left ventricular ejection fraction (LVEF) ≥ the lower limit of the institutional limits of normal.
Male or females ≥ 18 years of age.
Female patients must not be of child-bearing potential or must agree to use adequate contraceptive measures.
Male patients willing to use adequate contraceptive measures.
Willingness and ability to comply with the trial and follow-up procedures.
Ability to understand the nature of this trial and give written informed consent.

Who cannot join

Currently receiving or have received systemic cancer therapy (chemotherapy, biologic therapy) ≤ 21 days of initiating study therapy. For patients receiving small molecule targeted therapy, study treatment may begin >21 days after last dose or >5 half lives of previous treatment, whichever is shorter. Patients must have completed radiation therapy ≥7 days prior to starting study treatment. Patients must have recovered from or come to a new chronic stable baseline from all treatment-related toxicities. Dexamethasone or other high-dose steroid therapy must be stopped ≥ days prior to starting study treatment.
Previous treatment with HDAC, DAC, HSP90 or valproic acid for treatment of cancer.
Requires valproic acid for any medical condition during the study ≤5 days prior to first panobinostat treatment.
Patient has not recovered from all therapy-related toxicities associated with prior treatments to < Grade 2 CTCAE.
Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib).
Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis ≤14 days prior to study entry.

Show all 16Show fewer

Patients using medications that have a risk of prolonging the QT interval or inducing Torsade de Pointes if treatment cannot be discontinued or switched to a different medication prior to receiving study drug.
Patients with > grade 2 diarrhea.
Patients with impaired cardiac function.
Infection requiring IV antibiotics.
Patients with > grade 2 peripheral neuropathy or with uncontrolled pain.
Women who are pregnant or lactating.
Any concurrent medical illness that may impair the ability of the patient to tolerate study treatment and comply with the requirements of the study.
Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.
Use of any non-approved or investigational agent ≤30 days prior to administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
Presence of other active cancers, or history of treatment for invasive cancer ≤ 5 years. Patients with stage I cancer who have received definitive local treatment at least 3 years previously, and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (i.e. non-invasive) are eligible, as are patients with history of non-melanoma skin cancer.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Tennessee Oncology-Chattanooga
Chattanooga, Tennessee, 37404
Oncology Hematology Care, Inc.
Cincinnati, Ohio, 45242
Colorado Blood Cancer Institute
Denver, Colorado, 80218
Florida Cancer Specialists South
Fort Myers, Florida, 33916
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104
Research Medical Center
Kansas City, Missouri, 64132
Cancer Centers of Southwest Oklahoma
Lawton, Oklahoma, 73505
Hematology-Oncology Associates - Northern NJ
Morristown, New Jersey, 07962
Tennessee Oncology
Nashville, Tennessee, 37205
Woodlands Medical Specialists
Pensacola, Florida, 32503
Florida Cancer Specialists North
St. Petersburg, Florida, 33705
Providence Medical Group
Terre Haute, Indiana, 47802
RHHP/Hope Cancer Center
Terre Haute, Indiana, 47802

Other trials in United States

About this study

Official title: Phase I/II Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma

Relapsed/refractory Multiple Myeloma (MM) is an incurable disorder with a poor prognosis. Carfilzomib is a novel proteasome inhibitor with activity in this setting. Panobinostat is a pan-deacetylase inhibitor which has shown synergistic cytotoxicity in vitro and in vivo with proteasome inhibitors. The combination should enhance the activity of both agents against myeloma cells. In Phase I, the optimal doses of the combination of carfilzomib and panobinostat will be determined. Assuming this combination is feasible, the Phase II portion will proceed using the doses determined in Phase I.

Read the detailed description

In this open-label, non-randomized Phase I/II study, a maximum of 4 planned dose levels of carfilzomib and panobinostat were evaluated to determine the maximum tolerated dose (MTD) to administer. The MTD was not reached so patients in Phase II received treatment at dose level 4 to further assess efficacy. Response to treatment was evaluated after each 4-week cycle. Those having an objective response or stable disease are continuing treatment until disease progression or unacceptable toxicity occurs.

As the MTD in the 4 planned dose levels were not reached, a parallel Phase I study was initiated to examine additional dose levels using a traditional 3+3 design. If these dose levels are tolerable, then more patients will be recruited into an expansion cohort to assess efficacy at the new dose level(s).

Conditions: Multiple Myeloma
Being tested: panobinostat, carfilzomib
Keywords: Relapsed/Refractory Multiple Myeloma, carfilzomib, panobinostat
Medical subject headings: Multiple Myeloma

What participants receive

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

panobinostatDrug
Also called LBH589 (Panobinostat)
Specified dose on specified days
carfilzomibDrug
Also called PX-171-007
Specified dose on specified days

Study groups in NCT01496118
Study group	Role	What they receive
Carfilzomib and Panobinostat	Experimental	Phase I: Carfilzomib: cycle 1 - Dose is 20 mg/m^2 IV on day 1; 27 or 36 or 45 or 56 mg/m^2 IV on Days 8, 9, 15, 16 cycle 2 to progression - 27 or 36 or 45 or 56 mg/m^2 IV on days 1, 2, 8, 9, 15, 16 Panobinostat: cycle 1 and cycle 2 to progression - 20 mg or 30 mg on days 1, 3, 5, 15, 17, 19 Phase II: Carfilzomib and Panobinostat: Dose is optimal dose determined in Phase I Receives: Drug: panobinostat; Drug: carfilzomib

What is being measured

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

Number of Phase I Patients (Dose Level 1-6) Experiencing a Dose-Limiting Toxicity (DLT) to Determine the Optimal Dosage
Using a traditional 3+3 dose escalation design, successive cohorts of subjects will receive a fixed dose level of the drug combination. The MTD is defined as the highest dose level at which ≤1 of 6 subjects experiences a dose-limiting toxicity (DLT) assessed by NCI CTCAE v4.0. DLT is defined as any of the following that are determined to be related to study treatment during Cycle 1:
Grade 4 neutropenia for >7 days, Febrile neutropenia, Grade 3 thrombocytopenia with ≥ Grade 2 bleeding, Grade 4 thrombocytopenia > 7 days, ≥ Grade 2 neuropathy with uncontrolled pain, ≥ Grade 3 non-hematologic drug-related toxicity (excluding alopecia), despite optimal supportive care lasting >72 hours or requiring a dose reduction in the first cycle and Patients who are unable to receive 75% of the required doses of both agents secondary to toxicity. Number of Participants With such Dose Limiting Toxicities (DLT) at each level are reported here.
Measured: 28 days from the start of study treatment
Phase II: Overall Response Rate
Defined as the percentage of patients with confirmed complete response, very good partial response, or partial response (CR, VGPR, or PR) according to International Myeloma Working Group Uniform Response Criteria. CR=bone marrow contains ≤5% plasma cells; negative fixation on serum and urine; disappearance of soft tissue plasmacytomas. VGPR=≥90% reduction from baseline serum; urine M-protein level 100mg for 24h. PR=≥50% reduction from baseline in serum M-protein; disappearance of any soft tissue plasmacytomas.
Measured: up to 6 years

Secondary outcomes (3)

Time-to-progression (TTP)
Measured from date of first treatment until date of first documented progression as per International Myeloma Working Group Uniform Response Criteria. Progressive disease id defined as an increase of ≥ 25% from the nadir in at least one of the following criteria: serum M-protein (absolute increase must be ≥0.5 g/dL); urine M-protein (absolute increase must be ≥200 mg/24h) ; only in patients with non-measurable serum and urine M-protein levels: difference in involved and uninvolved FLC levels (absolute increase must be >10 mg/dL); only in patients with non-measurable serum and urine M-protein levels and non-measurable disease by FLC levels, bone marrow plasma cell percentage (absolute % must be ≥10%) OR Definite development of new bone lesions or soft tissue plasmacytomas OR definite increase in the size of existing bone lesions or soft tissue plasmacytomas OR Development of hypercalcemia (corrected serum Ca >11.5mg/dL) for patients without hypercalcemia at baseline
Measured: up to 6 years
Progression-free-survival (PFS)
Measured from date of first protocol treatment until date of tumor progression or death as per International Myeloma Working Group Uniform Response Criteria. Progressive disease id defined as an increase of ≥ 25% from the nadir in at least one of the following criteria: serum M-protein (absolute increase must be ≥0.5 g/dL); urine M-protein (absolute increase must be ≥200 mg/24h) ; only in patients with non-measurable serum and urine M-protein levels: difference in involved and uninvolved FLC levels (absolute increase must be >10 mg/dL); only in patients with non-measurable serum and urine M-protein levels and non-measurable disease by FLC levels, bone marrow plasma cell percentage (absolute % must be ≥10%) OR Definite development of new bone lesions or soft tissue plasmacytomas OR definite increase in the size of existing bone lesions or soft tissue plasmacytomas OR Development of hypercalcemia (corrected serum Ca >11.5mg/dL) for patients without hypercalcemia at baseline
Measured: up to 6 years
Overall-survival (OS)
Measured from time of first study treatment until date of death or date last known alive.
Measured: up to 6 years

Timeline

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

Dec 2011Dec 2020

First posted21 Dec 2011 (estimated)
Study startDec 2011
Primary completionDec 2020
Study completionDec 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 (2)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01496118
Sponsor's protocol ID: SCRI MM 27
Status last verified: Jan 2022
First submitted: 15 Dec 2011
Last updated: 2 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Berdeja JG, Gregory TK, Faber EA, Hart LL, Mace JR, Arrowsmith ER, Flinn IW, Matous JV. A phase I/II study of the combination of panobinostat and carfilzomib in patients with relapsed or relapsed/refractory multiple myeloma: Final analysis of second dose-expansion cohort. Am J Hematol. 2021 Apr 1;96(4):428-435. doi: 10.1002/ajh.26088. Epub 2021 Jan 28.
PubMed 33421178
Berdeja JG, Hart LL, Mace JR, Arrowsmith ER, Essell JH, Owera RS, Hainsworth JD, Flinn IW. Phase I/II study of the combination of panobinostat and carfilzomib in patients with relapsed/refractory multiple myeloma. Haematologica. 2015 May;100(5):670-6. doi: 10.3324/haematol.2014.119735. Epub 2015 Feb 20.
PubMed 25710456

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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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT01496118
Acronym / sponsor ID: SCRI MM 27
Conditions: Multiple Myeloma
Keywords: Relapsed/Refractory Multiple Myeloma, carfilzomib, panobinostat
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: SCRI Development Innovations, LLCUniversity, hospital or other
Collaborators: Onyx Therapeutics, Inc., Novartis
Study start: Dec 2011
Primary completion: Dec 2020 (actual)
Study completion: Dec 2020 (actual)
First posted: 21 Dec 2011 (estimated)
Results: Posted 2 Feb 2022

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Carfilzomib and Panobinostat	Experimental	Drug: panobinostat, Drug: carfilzomibPhase I: Carfilzomib: cycle 1 - Dose is 20 mg/m^2 IV on day 1; 27 or 36 or 45 or 56 mg/m^2 IV on Days 8, 9, 15, 16 cycle 2 to progression - 27 or 36 or 45 or 56 mg/m^2 IV on days 1, 2, 8, 9, 15, 16 Panobinostat: cycle 1 and cycle 2 to progression - 20 mg or 30 mg on days 1, 3, 5, 15, 17, 19 Phase II: Carfilzomib and Panobinostat: Dose is optimal dose determined in Phase I

Who may qualify

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

Key inclusion criteria (21 listed)

Eligible participants must have multiple myeloma using standard criteria.
Patients must have measurable disease requiring systemic therapy defined as at least one of the following:
Must have progressed during or after at least one previous bortezomib-containing treatment regimen. Patients who have received previous high-dose therapy/autologous stem cell transplantation are eligible.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Must meet the following laboratory criteria:

Key exclusion criteria (16 listed)

Currently receiving or have received systemic cancer therapy (chemotherapy, biologic therapy) ≤ 21 days of initiating study therapy. For patients receiving small molecule targeted therapy, study treatment may begin >21 days after last dose or >5 half lives of previous treatment, whichever is shorter. Patients must have completed radiation therapy ≥7 days prior to starting study treatment. Patients must have recovered from or come to a new chronic stable baseline from all treatment-related toxicities. Dexamethasone or other high-dose steroid therapy must be stopped ≥ days prior to starting study treatment.
Previous treatment with HDAC, DAC, HSP90 or valproic acid for treatment of cancer.
Requires valproic acid for any medical condition during the study ≤5 days prior to first panobinostat treatment.
Patient has not recovered from all therapy-related toxicities associated with prior treatments to < Grade 2 CTCAE.
Known history of allergy to Captisol® (a cyclodextrin derivative used to solubilize carfilzomib).

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
panobinostatAlso: LBH589 (Panobinostat)Specified dose on specified days	Drug	Carfilzomib and Panobinostat
carfilzomibAlso: PX-171-007Specified dose on specified days	Drug	Carfilzomib and Panobinostat

Primary outcome

Number of Phase I Patients (Dose Level 1-6) Experiencing a Dose-Limiting Toxicity (DLT) to Determine the Optimal Dosage
Time frame: 28 days from the start of study treatment
Using a traditional 3+3 dose escalation design, successive cohorts of subjects will receive a fixed dose level of the drug combination. The MTD is defined as the highest dose level at which ≤1 of 6 subjects experiences a dose-limiting toxicity (DLT) assessed by NCI CTCAE v4.0. DLT is defined as any of the following that are determined to be related to study treatment during Cycle 1: Grade 4 neutropenia for >7 days, Febrile neutropenia, Grade 3 thrombocytopenia with ≥ Grade 2 bleeding, Grade 4 thrombocytopenia > 7 days, ≥ Grade 2 neuropathy with uncontrolled pain, ≥ Grade 3 non-hematologic drug-related toxicity (excluding alopecia), despite optimal supportive care lasting >72 hours or requiring a dose reduction in the first cycle and Patients who are unable to receive 75% of the required doses of both agents secondary to toxicity. Number of Participants With such Dose Limiting Toxicities (DLT) at each level are reported here.
Phase II: Overall Response Rate
Time frame: up to 6 years
Defined as the percentage of patients with confirmed complete response, very good partial response, or partial response (CR, VGPR, or PR) according to International Myeloma Working Group Uniform Response Criteria. CR=bone marrow contains ≤5% plasma cells; negative fixation on serum and urine; disappearance of soft tissue plasmacytomas. VGPR=≥90% reduction from baseline serum; urine M-protein level 100mg for 24h. PR=≥50% reduction from baseline in serum M-protein; disappearance of any soft tissue plasmacytomas.

3 secondary outcomes

Time-to-progression (TTP)
Time frame: up to 6 years
Progression-free-survival (PFS)
Time frame: up to 6 years
Overall-survival (OS)
Time frame: up to 6 years

Results and safety

Results posted to the registry on 2 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Level 1	4	0
Dose Level 2	3	0
Dose Level 3	3	0
Dose Level 4	3	0
Dose Level 5	3	0
Dose Level 6	3	0
Expansion Dose Level 4	31	0
Expansion Dose Level 6	30	0

Primary outcome: Number of Phase I Patients (Dose Level 1-6) Experiencing a Dose-Limiting Toxicity (DLT) to Determine the Optimal Dosage

Time frame: 28 days from the start of study treatment. Count of participants. Unit: Participants

Measure	Dose Level 1 n = 4	Dose Level 2 n = 3	Dose Level 3 n = 3	Dose Level 4 n = 3	Dose Level 5 n = 3	Dose Level 6 n = 3
Value	0	0	0	0	0	0

Population analysed: Includes all Phase 1 patients receiving assigned study dosing

Primary outcome: Phase II: Overall Response Rate

Time frame: up to 6 years. Number. Unit: percentage of participants

Measure	Dose Level 4 - Escalation and Expansion n = 31	Dose Level 6 - Escalation and Expansion n = 32
Value	74	84

Population analysed: All patients receiving dose level 4 and dose level 6 doses (both escalation and expansion phases combined) who had a post-baseline disease assessment per protocol were included in the analysis. 3 patients in dose level 4 and 1 patient in dose level 6 did not have a post-baseline assessment and were excluded from analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From date of first treatment up to 6 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Level 1	1 of 4 (25%)	4 of 4 (100%)	3 of 4
Dose Level 2	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Dose Level 3	0 of 3 (0%)	3 of 3 (100%)	1 of 3
Dose Level 4	2 of 3 (66.7%)	3 of 3 (100%)	1 of 3
Dose Level 5	1 of 3 (33.3%)	3 of 3 (100%)	2 of 3
Dose Level 6	0 of 3 (0%)	3 of 3 (100%)	2 of 3
Expansion Dose Level 4	16 of 31 (51.6%)	31 of 31 (100%)	20 of 31
Expansion Dose Level 6	13 of 30 (43.3%)	30 of 30 (100%)	12 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33421178Berdeja JG, Gregory TK, Faber EA, Hart LL, Mace JR, Arrowsmith ER, Flinn IW, Matous JV. A phase I/II study of the combination of panobinostat and carfilzomib in patients with relapsed or relapsed/refractory multiple myeloma: Final analysis of second dose-expansion cohort. Am J Hematol. 2021 Apr 1;96(4):428-435. doi: 10.1002/ajh.26088. Epub 2021 Jan 28.
Derived from this study: PubMed 25710456Berdeja JG, Hart LL, Mace JR, Arrowsmith ER, Essell JH, Owera RS, Hainsworth JD, Flinn IW. Phase I/II study of the combination of panobinostat and carfilzomib in patients with relapsed/refractory multiple myeloma. Haematologica. 2015 May;100(5):670-6. doi: 10.3324/haematol.2014.119735. Epub 2015 Feb 20.

Related trials for Multiple Myeloma

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)
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Active, not recruitingPhase 3
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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.

Jesus Berdeja, MD study chair

SCRI Development Innovations, LLC

13 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 panobinostat and carfilzomib in people with Multiple Myeloma, run by SCRI Development Innovations, LLC at 13 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 21 inclusion and 16 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 2 Feb 2022. 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. 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 2 Feb 2022). 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?

Number of Phase I Patients (Dose Level 1-6) Experiencing a Dose-Limiting Toxicity (DLT) to Determine the Optimal Dosage (time frame: 28 days from the start of study 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?

On the ClinicalTrials.gov record for NCT01496118, which also lists 2 linked publications.

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 2 Feb 2022.