LeukemiaPhase 2NCT00607997

Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia

A Phase 2 study testing vosaroxin in people with Leukemia and Acute Disease, run by Sunesis Pharmaceuticals at 20 sites 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 will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML Read more about this study

Who is it for?: Ages 60 years and older
Conditions the study is for: Leukemia, Acute Disease, Acute Myeloid Leukemia
What is being tested?: vosaroxin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 113 participants
Where: 20 sitesUnited States
Study dates: 15 May 2008to 23 Nov 2009
Phase: Phase 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 60 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

At least 60 years of age and diagnosis of previously untreated AML (either de novo or from an antecedent hematologic disorder or therapy related AML)
At least 20% blasts by BM biopsy or aspirate
ECOG performance status of 0,1,or 2
Adequate cardiac, renal and liver function

Who cannot join

Uncontrolled DIC
Active central nervous system involvement by AML
Requiring hemodialysis or peritoneal dialysis
Some prior history of heart attack or stroke (depending on how long ago the event occurred)

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
The University of Chicago
Chicago, Illinois, 60637
University of MO Ellis Fischel Cancer Center
Columbia, Missouri, 65203
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, 80218
MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Cancer Center
Indianapolis, Indiana, 46206
St. Francis Hospital & Health Systems at Beech Grove Campus
Indianapolis, Indiana, 46237
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Scripps Cancer Center
La Jolla, California, 92037
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Mayo Clinic Hospital
Phoenix, Arizona, 85054
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103
Cancer Center of Kansas
Wichita, Kansas, 67208
Cancer Center of Kansas
Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: A Phase 2, Open-Label, Multicenter Clinical Study of the Safety and Efficacy of Voreloxin (Vosaroxin) Injection in Patients Equal to or Greater Than 60 Years of Age With Previously Untreated Acute Myeloid Leukemia

This study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML

Read the detailed description

Other objectives of this study include:

Assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality
Assess leukemia free survival (LFS), event-free survival (EFS), overall survival (OS), and duration of remission (DR).
Characterize the pharmacokinetic (PK) profile of vosaroxin in this patient population.
Evaluate potential stratification biomarkers by evaluating DNA-damage and apoptotic pathways in bone marrow samples before and after treatment with vosaroxin

Conditions: Leukemia, Acute Disease, Acute Myeloid Leukemia, Nonlymphocytic Leukemia, Myelodysplastic Syndromes
Being tested: vosaroxin
Keywords: Leukemia, Myeloid, Elderly, Hematologic, Blood, Cancer, Malignancy, SNS-595, Sunesis, Hematologic Diseases, Myelodysplastic Syndromes, Older, voreloxin, reveal-1
Medical subject headings: Leukemia, Acute Disease, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Neoplasms, Hematologic Diseases

What participants receive

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

vosaroxinDrug
Also called voreloxin, SNS-595
Vosaroxin was administered by slow intravenous (IV) infusion or via syringe pump within 10 minutes.Patients could have completed up to 4 treatment cycles consisting of 1 or 2 induction treatment cycles and up to 2 consolidation treatment cycles. For Schedule A, an induction cycle was a minimum of 21 days during which patients received vosaroxin on Days 1, 8, and 15, followed by weekly observations until hematologic recovery for patients with aplastic marrow after the postinduction bone marrow assessment. For Schedules B and C, an induction cycle was a minimum of 15 days, during which patients received vosaroxin on Days 1 and 8 (Schedule B), or Days 1 and 4 (Schedule C), followed by the same weekly observations until hematologic recovery as for Schedule A.

Study groups in NCT00607997
Study group	Role	What they receive
All Study Patients	Experimental	* Schedule A: 72 mg/m2 vosaroxin Days 1, 8 and 15 * Schedule B: 72 mg/m2 vosaroxin on Days 1 and 8 * Schedule C: 72 mg/m2 on Days 1 and 4, or * Schedule C: 90 mg/m2 on Days 1 and 4 Receives: Drug: vosaroxin

What is being measured

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

Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions
Combined remission rate (complete remission [CR] + complete remission with incomplete platelet recovery [CRp]) of vosaroxin of patients ≥ 60 years old with previously untreated (de novo or secondary) AML are presented by treatment group for all treated analysis set.
Per IWG criteria, a CR requires bone marrow blasts < 5%, absolute neutrophil count (ANC) > 1000 cells/uL, and platelet (plt) count > 100,000 plt/uL. The criteria for CRp are the same as those for CR, except for platelet count <= 100,000 lt/uL. Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (Morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse.
Measured: 2 years

Secondary outcomes (13)

Leukemia-free Survival (LFS)
The censor date was the last known alive date without report of relapse.
Measured: 2 years
Overall Survival
Measured: 2 years
Pharmacokinetics Day 1 - Cmax (ng/mL)
Pharmacokinetic Parameters (Cmax) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Measured: 1 Day
Pharmacokinetics Day 4 Cmax (ng/mL)
Pharmacokinetic Parameters by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) on Day 4
Please note that N, mean and CV% are reported, but CV% is not an option in the drop down menu. So Standard Deviation is really CV% in the table.
Measured: Day 4
All Cause Mortality
Mortality of those patients enrolled in the study and receiving intervention
Measured: 30 and 60 days
Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL)
Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Measured: 1 Day
Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr)
Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Measured: 1 Day
Pharmacokinetics Day 1 - CL (L/hr)
Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Measured: 1 Day
Pharmacokinetics Day 1 - Vss (L)
Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Measured: 1 Day
Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL)
Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. Standard Deviation is really CV% in the table.
Measured: Day 4
Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr)
Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The Standard Deviation is really CV% in the table.
Measured: Day 4
Pharmacokinetics Day 4 - CL (L/hr)
Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Measured: Day 4
Pharmacokinetics Day 4 - Vss (L)
Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4
Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.
Measured: Day 4

Timeline

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

15 May 200823 Nov 2009

First posted6 Feb 2008 (estimated)
Study start15 May 2008
Primary completionNov 2009
Study completion23 Nov 2009

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 LeukemiaStudies 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00607997
Sponsor's protocol ID: SPO-0014
Status last verified: May 2017
First submitted: 23 Jan 2008
Last updated: 28 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified data of individual participants experiencing Serious Adverse Events

Publications

Stuart RK, Cripe LD, Maris MB, Cooper MA, Stone RM, Dakhil SR, Turturro F, Stock W, Mason J, Shami PJ, Strickland SA, Costa LJ, Borthakur G, Michelson GC, Fox JA, Leavitt RD, Ravandi F. REVEAL-1, a phase 2 dose regimen optimization study of vosaroxin in older poor-risk patients with previously untreated acute myeloid leukaemia. Br J Haematol. 2015 Mar;168(6):796-805. doi: 10.1111/bjh.13214. Epub 2014 Nov 17.
PubMed 25403830

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 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Open-Label, Multicenter Clinical Study of the Safety and Efficacy of Voreloxin (Vosaroxin) Injection in Patients Equal to or Greater Than 60 Years of Age With Previously Untreated Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT00607997
Acronym / sponsor ID: SPO-0014
Conditions: Leukemia, Acute Disease, Acute Myeloid Leukemia, Nonlymphocytic Leukemia, Myelodysplastic Syndromes
Keywords: Leukemia, Myeloid, Elderly, Hematologic, Blood, Cancer, Malignancy, SNS-595
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: Sunesis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 15 May 2008 (actual)
Primary completion: Nov 2009 (actual)
Study completion: 23 Nov 2009 (actual)
First posted: 6 Feb 2008 (estimated)
Results: Posted 28 Jun 2017

Clinical summary

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

This study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML

Detailed description

Other objectives of this study include:

Assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality
Assess leukemia free survival (LFS), event-free survival (EFS), overall survival (OS), and duration of remission (DR).
Characterize the pharmacokinetic (PK) profile of vosaroxin in this patient population.
Evaluate potential stratification biomarkers by evaluating DNA-damage and apoptotic pathways in bone marrow samples before and after treatment with vosaroxin

Study design

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

Arm	Type	Receives
All Study Patients	Experimental	Drug: vosaroxin* Schedule A: 72 mg/m2 vosaroxin Days 1, 8 and 15 * Schedule B: 72 mg/m2 vosaroxin on Days 1 and 8 * Schedule C: 72 mg/m2 on Days 1 and 4, or * Schedule C: 90 mg/m2 on Days 1 and 4

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

At least 60 years of age and diagnosis of previously untreated AML (either de novo or from an antecedent hematologic disorder or therapy related AML)
At least 20% blasts by BM biopsy or aspirate
ECOG performance status of 0,1,or 2
Adequate cardiac, renal and liver function

Key exclusion criteria (4 listed)

Uncontrolled DIC
Active central nervous system involvement by AML
Requiring hemodialysis or peritoneal dialysis
Some prior history of heart attack or stroke (depending on how long ago the event occurred)

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
vosaroxinAlso: voreloxin, SNS-595Vosaroxin was administered by slow intravenous (IV) infusion or via syringe pump within 10 minutes.Patients could have completed up to 4 treatment cycles consisting of 1 or 2 induction treatment cycles and up to 2 consolidation treatment cycles. For Schedule A, an induction cycle was a minimum of 21 days during which patients received vosaroxin on Days 1, 8, and 15, followed by weekly observations until hematologic recovery for patients with aplastic marrow after the postinduction bone marrow assessment. For Schedules B and C, an induction cycle was a minimum of 15 days, during which patients received vosaroxin on Days 1 and 8 (Schedule B), or Days 1 and 4 (Schedule C), followed by the same weekly observations until hematologic recovery as for Schedule A.	Drug	All Study Patients

Primary outcome

Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions
Time frame: 2 years
Combined remission rate (complete remission [CR] + complete remission with incomplete platelet recovery [CRp]) of vosaroxin of patients ≥ 60 years old with previously untreated (de novo or secondary) AML are presented by treatment group for all treated analysis set. Per IWG criteria, a CR requires bone marrow blasts < 5%, absolute neutrophil count (ANC) > 1000 cells/uL, and platelet (plt) count > 100,000 plt/uL. The criteria for CRp are the same as those for CR, except for platelet count <= 100,000 lt/uL. Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (Morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse.

13 secondary outcomes

Leukemia-free Survival (LFS)
Time frame: 2 years
Overall Survival
Time frame: 2 years
Pharmacokinetics Day 1 - Cmax (ng/mL)
Time frame: 1 Day
Pharmacokinetics Day 4 Cmax (ng/mL)
Time frame: Day 4
All Cause Mortality
Time frame: 30 and 60 days
Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL)
Time frame: 1 Day
Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr)
Time frame: 1 Day
Pharmacokinetics Day 1 - CL (L/hr)
Time frame: 1 Day
Pharmacokinetics Day 1 - Vss (L)
Time frame: 1 Day
Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL)
Time frame: Day 4
Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr)
Time frame: Day 4
Pharmacokinetics Day 4 - CL (L/hr)
Time frame: Day 4
Pharmacokinetics Day 4 - Vss (L)
Time frame: Day 4

Results and safety

Results posted to the registry on 28 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	29	2
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8	35	8
Schedule C: 72 mg/m2 on Days 1 and 4	29	5
Schedule C: 90 mg/m2 on Days 1 and 4	20	4

Primary outcome: Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions

Time frame: 2 years. Number (95% Confidence Interval). Unit: percentage of patients

Measure	Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 n = 29	Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 n = 35	Schedule C: 72 mg/m2 on Days 1 and 4 n = 29	Schedule C: 90 mg/m2 on Days 1 and 4 n = 20	Total n = 113
Value	41.4 (23.5 to 61.1)	25.7 (12.5 to 43.3)	34.5 (17.9 to 54.3)	25.0 (8.7 to 49.1)	31.9 (24.3 to 41.3)

Population analysed: The all treated analysis set Included all enrolled patients who received any amount of vosaroxin.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study Start: 15 May 2008, Study Completion: 23 November 2009.Treatment-Emergent Adverse Events. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15	25 of 29 (86.2%)	29 of 29 (100%)	25 of 29
Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8	29 of 35 (82.9%)	35 of 35 (100%)	31 of 35
Schedule C: 72 mg/m2 on Days 1 and 4	21 of 29 (72.4%)	29 of 29 (100%)	28 of 29
Schedule C: 90 mg/m2 on Days 1 and 4	17 of 20 (85%)	20 of 20 (100%)	19 of 20

Limitations and caveats (from the sponsor): Due to the limited sample size in this study, further study is needed to confirm these results. No statistical testings were performed to compare any of the treatment groups. No p-values or odds ratios were reported.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25403830Stuart RK, Cripe LD, Maris MB, Cooper MA, Stone RM, Dakhil SR, Turturro F, Stock W, Mason J, Shami PJ, Strickland SA, Costa LJ, Borthakur G, Michelson GC, Fox JA, Leavitt RD, Ravandi F. REVEAL-1, a phase 2 dose regimen optimization study of vosaroxin in older poor-risk patients with previously untreated acute myeloid leukaemia. Br J Haematol. 2015 Mar;168(6):796-805. doi: 10.1111/bjh.13214. Epub 2014 Nov 17.
Individual participant dataSharing planned: Yes. De-identified data of individual participants experiencing Serious Adverse Events

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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 Craig, MD study director

Sunesis Pharmaceuticals

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing vosaroxin in people with Leukemia and Acute Disease, run by Sunesis Pharmaceuticals at 20 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 4 inclusion and 4 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 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 phase mean?

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 28 Jun 2017). 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?

Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions (time frame: 2 years). 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 NCT00607997, 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 28 Jun 2017.