Relapsed or Refractory Multiple MyelomaPhase 1NCT00642954

Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074)

A Phase 1 study testing Vorinostat, Lenalidomide and Dexamethasone in people with Relapsed or Refractory Multiple Myeloma, run by Merck Sharp & Dohme LLC.

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

The purpose of this Phase I study of vorinostat in combination with lenalidomide and dexamethasone in participants with relapsed or refractory multiple myeloma is to determine the maximum tolerated dose (MTD) as estimated by the incidence of dose-limiting toxicities (DLTs) and recommended Phase 2 dose (RP2D) as… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsed or Refractory Multiple Myeloma
What is being tested?: Vorinostat, Lenalidomide and Dexamethasone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: No sites listed yet
Study dates: 13 Feb 2008to 20 Aug 2013
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

Is a male or female at least 18 years old
Has relapsed or refractory MM and has had at least one prior therapy
Female participants of childbearing potential must have 2 negative serum pregnancy tests prior to receiving the first dose of study drugs
Female participants who can become pregnant must agree to use 2 separate forms of effective birth control at the same time, 4 weeks before, while taking, and for 4 weeks after stopping lenalidomide; post menopausal participants should be free from menses for >2 years, or are surgically sterilized
Male participant agrees to use an adequate method of contraception for the duration of the study, even if the participant has undergone a successful vasectomy
Male participants must agree to use a latex condom during sexual contact with a pregnant female or a female who can become pregnant; this is required for the duration of the study, and for 4 weeks after stopping therapy
Has at least 3 weeks washout prior to treatment
Is able to swallow capsules and is able to take or tolerate oral medications on a continuous basis

Who cannot join

Has prior treatment with a histone deacetylase (HDAC) inhibitor
Has prior allogenetic bone marrow transplant
Has received intravenous antibiotics, antiviral, or antifungal agents within 2 weeks prior to the start of the study drug
Uses illicit drugs, substance abuse or had a recent history (within the last year) of drug or alcohol abuse
Is pregnant or breast feeding or expecting to have a baby during the course of the study
Has human immunodeficiency virus (HIV) infection
Has Hepatitis B/C infection
Is currently receiving treatment for another type of cancer other than skin or cervical cancer that has not been in remission for 5 years or longer

About this study

Official title: A Phase I Study of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Conditions: Relapsed or Refractory Multiple Myeloma
Being tested: Vorinostat, Lenalidomide, Dexamethasone
Medical subject headings: Recurrence, Multiple Myeloma

What participants receive

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

VorinostatDrug
Also called MK-0683, Suberoylanilide hydroxamic acid, Zolinza
Vorinostat 300 mg or 400 mg QD via oral capsule on Days 1-7 and Days 15-21 of each 28-day cycle.
LenalidomideDrug
Also called Revlimid
Lenalidomide 10 mg, 15 mg, 20 mg or 25 mg QD via oral capsule on Days 1-21 of each 28-day cycle.
DexamethasoneDrug
Also called Decadron
Dexamethasone 40 mg QD via oral tablet on Days 1, 8, 15 and 22 of each 28-day cycle.

Study groups in NCT00642954
Study group	Role	What they receive
Level 1: Vorinostat 300 mg + lenalidomide 10 mg	Experimental	Participants will receive vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity. Receives: Drug: Vorinostat; Drug: Lenalidomide; Drug: Dexamethasone
Level 2: Vorinostat 400 mg + lenalidomide 10 mg	Experimental	Participants will receive vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity. Receives: Drug: Vorinostat; Drug: Lenalidomide; Drug: Dexamethasone
Level 3: Vorinostat 400 mg + lenalidomide 15 mg	Experimental	Participants will receive vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity. Receives: Drug: Vorinostat; Drug: Lenalidomide; Drug: Dexamethasone
Level 4: Vorinostat 400 mg + lenalidomide 20 mg	Experimental	Participants will receive vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity. Receives: Drug: Vorinostat; Drug: Lenalidomide; Drug: Dexamethasone
Level 5: Vorinostat 400 mg + lenalidomide 25 mg	Experimental	Participants will receive vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity. Receives: Drug: Vorinostat; Drug: Lenalidomide; Drug: Dexamethasone

What is being measured

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

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
DLTs consisted of hematologic or non-hemtologic toxicities. Hematologic DLT was any grade (gr) 4 neutropenia lasting ≥7 days, gr 4 thrombocytopenia or gr 5 hematologic toxicity. Non-hematologic DLT was any gr 3, 4 or 5 non-hematologic toxicity with the exception of (1) gr 3 nausea, vomiting, diarrhea or dehydration not compliant with medical care, lasting <48 hours (2) gr 3 acidosis/alkalosis returning to ≤ gr 2 by 48 hours of medical care (3) gr 3 liver function test elevation without symptoms, lasting ≤5 days (4) Gr 3 amylase elevation without symptoms (5) Gr 3 hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia or hyphosphatemia responding to medical care (6) Gr 3 hypercholeresterolemia or hypertriglyceridemia. A drug-related AE causing dose modification of study drug is also considered a DLT. Per protocol DLTs were analyzed in the first 28-day treatment cycle. The number of participants experiencing DLTs is reported here for all participants who got ≥1 dose of study drug.
Measured: Cycle 1 (Up to 28 days)

Secondary outcomes (1)

Number of Participants Experiencing Drug-Related Adverse Events (AEs)
An AE was defined as any unfavorable and unintended change in the structure, function or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. Any worsening of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. An AE was considered related to a drug as determined by the investigator based on exposure (evidence of exposure to drug), time course (time of AE onset versus drug-induced effect), likely cause (AE etiology related or un-related to drug), de-challenge (drug dose reduction/discontinuation) or re-challenge (drug re-exposure). Per protocol participants experiencing drug-related AEs were analyzed at the time of the protocol-specified final statistical analysis with a 3-September (Sep)-2012 data cut-off. The number of participants experiencing drug-related AEs is reported here for all participants who got ≥1 dose of study drug.
Measured: Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)

Timeline

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

13 Feb 200820 Aug 2013

First posted25 Mar 2008 (estimated)
Study start13 Feb 2008
Primary completion3 Sep 2012
Study completion20 Aug 2013

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 Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00642954
Sponsor's protocol ID: 0683-074
Other IDs: 2007_511, 2007-001033-34, MK-0683-074
Status last verified: Oct 2020
First submitted: 17 Mar 2008
Last updated: 18 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Siegel DS, Richardson P, Dimopoulos M, Moreau P, Mitsiades C, Weber D, Houp J, Gause C, Vuocolo S, Eid J, Graef T, Anderson KC. Vorinostat in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood Cancer J. 2014 Feb 21;4(2):e182. doi: 10.1038/bcj.2014.1.
PubMed 24562384

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?

Official record

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 1
A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
Relapsed or Refractory Multiple Myeloma
Active, not recruitingPhase 3
A Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma
Multiple Myeloma
RecruitingPhase 2
Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse
Recurrent Multiple Myeloma, Refractory Multiple Myeloma
RecruitingPhase 1
In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies
B-Acute Lymphoblastic Leukemia, B Cell Non-Hodgkin's Lymphoma

All Relapsed or Refractory Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Study of Vorinostat in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT00642954
Acronym / sponsor ID: 0683-074
Conditions: Relapsed or Refractory Multiple Myeloma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 13 Feb 2008 (actual)
Primary completion: 3 Sep 2012 (actual)
Study completion: 20 Aug 2013 (actual)
First posted: 25 Mar 2008 (estimated)
Results: Posted 18 Nov 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Level 1: Vorinostat 300 mg + lenalidomide 10 mg	Experimental	Drug: Vorinostat, Drug: Lenalidomide, Drug: DexamethasoneParticipants will receive vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity.
Level 2: Vorinostat 400 mg + lenalidomide 10 mg	Experimental	Drug: Vorinostat, Drug: Lenalidomide, Drug: DexamethasoneParticipants will receive vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity.
Level 3: Vorinostat 400 mg + lenalidomide 15 mg	Experimental	Drug: Vorinostat, Drug: Lenalidomide, Drug: DexamethasoneParticipants will receive vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity.
Level 4: Vorinostat 400 mg + lenalidomide 20 mg	Experimental	Drug: Vorinostat, Drug: Lenalidomide, Drug: DexamethasoneParticipants will receive vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity.
Level 5: Vorinostat 400 mg + lenalidomide 25 mg	Experimental	Drug: Vorinostat, Drug: Lenalidomide, Drug: DexamethasoneParticipants will receive vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles. Qualified participants who don't have disease progression can continue treatment after 8 cycles at the same dose and schedule, until progressive disease or unacceptable toxicity.

Who may qualify

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

Key inclusion criteria (8 listed)

Is a male or female at least 18 years old
Has relapsed or refractory MM and has had at least one prior therapy
Female participants of childbearing potential must have 2 negative serum pregnancy tests prior to receiving the first dose of study drugs
Female participants who can become pregnant must agree to use 2 separate forms of effective birth control at the same time, 4 weeks before, while taking, and for 4 weeks after stopping lenalidomide; post menopausal participants should be free from menses for >2 years, or are surgically sterilized
Male participant agrees to use an adequate method of contraception for the duration of the study, even if the participant has undergone a successful vasectomy

Key exclusion criteria (8 listed)

Has prior treatment with a histone deacetylase (HDAC) inhibitor
Has prior allogenetic bone marrow transplant
Has received intravenous antibiotics, antiviral, or antifungal agents within 2 weeks prior to the start of the study drug
Uses illicit drugs, substance abuse or had a recent history (within the last year) of drug or alcohol abuse
Is pregnant or breast feeding or expecting to have a baby during the course of the study

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
VorinostatAlso: MK-0683, Suberoylanilide hydroxamic acid, ZolinzaVorinostat 300 mg or 400 mg QD via oral capsule on Days 1-7 and Days 15-21 of each 28-day cycle.	Drug	Level 1: Vorinostat 300 mg + lenalidomide 10 mg, Level 2: Vorinostat 400 mg + lenalidomide 10 mg, Level 3: Vorinostat 400 mg + lenalidomide 15 mg, Level 4: Vorinostat 400 mg + lenalidomide 20 mg, Level 5: Vorinostat 400 mg + lenalidomide 25 mg
LenalidomideAlso: RevlimidLenalidomide 10 mg, 15 mg, 20 mg or 25 mg QD via oral capsule on Days 1-21 of each 28-day cycle.	Drug	Level 1: Vorinostat 300 mg + lenalidomide 10 mg, Level 2: Vorinostat 400 mg + lenalidomide 10 mg, Level 3: Vorinostat 400 mg + lenalidomide 15 mg, Level 4: Vorinostat 400 mg + lenalidomide 20 mg, Level 5: Vorinostat 400 mg + lenalidomide 25 mg
DexamethasoneAlso: DecadronDexamethasone 40 mg QD via oral tablet on Days 1, 8, 15 and 22 of each 28-day cycle.	Drug	Level 1: Vorinostat 300 mg + lenalidomide 10 mg, Level 2: Vorinostat 400 mg + lenalidomide 10 mg, Level 3: Vorinostat 400 mg + lenalidomide 15 mg, Level 4: Vorinostat 400 mg + lenalidomide 20 mg, Level 5: Vorinostat 400 mg + lenalidomide 25 mg

Primary outcome

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1 (Up to 28 days)
DLTs consisted of hematologic or non-hemtologic toxicities. Hematologic DLT was any grade (gr) 4 neutropenia lasting ≥7 days, gr 4 thrombocytopenia or gr 5 hematologic toxicity. Non-hematologic DLT was any gr 3, 4 or 5 non-hematologic toxicity with the exception of (1) gr 3 nausea, vomiting, diarrhea or dehydration not compliant with medical care, lasting <48 hours (2) gr 3 acidosis/alkalosis returning to ≤ gr 2 by 48 hours of medical care (3) gr 3 liver function test elevation without symptoms, lasting ≤5 days (4) Gr 3 amylase elevation without symptoms (5) Gr 3 hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia or hyphosphatemia responding to medical care (6) Gr 3 hypercholeresterolemia or hypertriglyceridemia. A drug-related AE causing dose modification of study drug is also considered a DLT. Per protocol DLTs were analyzed in the first 28-day treatment cycle. The number of participants experiencing DLTs is reported here for all participants who got ≥1 dose of study drug.

1 secondary outcome

Number of Participants Experiencing Drug-Related Adverse Events (AEs)
Time frame: Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)

Results and safety

Results posted to the registry on 18 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg	4	0
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg	4	0
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg	3	0
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg	3	0
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg	17	1

Primary outcome: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)

Time frame: Cycle 1 (Up to 28 days). Count of participants. Unit: Participants

Measure	Level 1: Vorinostat 300 mg + Lenalidomide 10 mg n = 4	Level 2: Vorinostat 400 mg + Lenalidomide 10 mg n = 4	Level 3: Vorinostat 400 mg + Lenalidomide 15 mg n = 3	Level 4: Vorinostat 400 mg + Lenalidomide 20 mg n = 3	Level 5: Vorinostat 400 mg + Lenalidomide 25 mg n = 17
Value	0	0	0	0	1

Population analysed: All participants who received ≥1 dose of study treatment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to ~66 months (through database cut-off date of 20-August-2013). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg	2 of 4 (50%)	4 of 4 (100%)	0 of 4
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg	1 of 4 (25%)	4 of 4 (100%)	1 of 4
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg	1 of 3 (33.3%)	3 of 3 (100%)	0 of 3
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg	2 of 3 (66.7%)	3 of 3 (100%)	0 of 3
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg	8 of 17 (47.1%)	17 of 17 (100%)	3 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24562384Siegel DS, Richardson P, Dimopoulos M, Moreau P, Mitsiades C, Weber D, Houp J, Gause C, Vuocolo S, Eid J, Graef T, Anderson KC. Vorinostat in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. Blood Cancer J. 2014 Feb 21;4(2):e182. doi: 10.1038/bcj.2014.1.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

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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.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vorinostat, Lenalidomide and Dexamethasone in people with Relapsed or Refractory Multiple Myeloma, run by Merck Sharp & Dohme LLC.

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 8 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 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

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 18 Nov 2020). 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 Participants Experiencing Dose-Limiting Toxicities (DLTs) (time frame: Cycle 1 (Up to 28 days)). 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 NCT00642954, 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 18 Nov 2020.