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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01191801




Registration number
NCT01191801
Ethics application status
Date submitted
27/08/2010
Date registered
31/08/2010

Titles & IDs
Public title
Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML
Scientific title
A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)
Secondary ID [1] 0 0
2010-021961-61
Secondary ID [2] 0 0
VOS-AML-301
Universal Trial Number (UTN)
Trial acronym
VALOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - vosaroxin + cytarabine
Treatment: Drugs - placebo + cytarabine

Experimental: Group A: vosaroxin + cytarabine - vosaroxin (short IV infusion within 10 minutes) on days 1 and 4: cytarabine on days 1 through 5; a maximum of 2 cycles of Induction and 2 cycles for Consolidation

Placebo comparator: Group B: placebo + cytarabine - placebo (short IV infusion within 10 minutes and volume matched to vosaroxin) on days 1 and 4: cytarabine on days 1 through 5; a maximum of 2 cycles of Induction and 2 cycles for Consolidation


Treatment: Drugs: vosaroxin + cytarabine
Vosaroxin days 1 and 4: 90 mg/m2 for induction 1; 70 mg/m2 for all other cycles

Cytarabine 1 g/m2 daily on days 1-5 (IDAC)

Treatment: Drugs: placebo + cytarabine
Placebo days 1 and 4: volume matched to vosaroxin

Cytarabine 1 g/m2 daily on days 1-5 (IDAC)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Up to 5 years or duration of study
Secondary outcome [1] 0 0
Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria.
Timepoint [1] 0 0
Up to 5 years or duration of study
Secondary outcome [2] 0 0
All Cause Mortality
Timepoint [2] 0 0
30 Days
Secondary outcome [3] 0 0
All Cause Mortality
Timepoint [3] 0 0
60 Days

Eligibility
Key inclusion criteria
* Provided signed, written informed consent
* At least 18 years of age
* Had a diagnosis of AML according to World Health Organization (WHO) classification
* First relapsed or refractory AML (refractory to initial induction therapy) with at least 5% blasts by bone marrow or aspirate or 1% blasts in peripheral blood with additional requirements for relapsed or refractory
* Had an ECOG score of 0-2
* Had adequate liver and renal function as indicated by certain laboratory values
* Had adequate cardiac function (left ventricular ejection fraction at least 40% by multiple gated acquisition scan or ECG)
* Nonfertile or agreed to use an adequate method of contraception until 30 days after the last treatment
* Had any clinically significant nonhematologic toxicity after prior chemotherapy recovered to Grade 1 per NCI-CTCAE
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Had acute promyelocytic leukemia
* Had more than 2 cycles of induction therapy for AML
* Had completed a single cycle of treatment containing a total dose of 5 g/m2 or more of cytarabine within 90 days before randomization
* Refractory to or relapsed within the previous 3 months after therapy with an IDAC- or HIDAC-containing regimen
* Had received a hematopoietic stem cell transplant (HSCT) within the previous 90 days
* Had received active immunosuppressive therapy for graft-versus-host disease (GVHD) within 2 weeks before study start
* Had any other severe concurrent disease, or have a history of serious disease involving the heart, kidney, liver, or other organ system
* Had evidence of central nervous system involvement of active AML
* Had other active malignancies (including other hematologic malignancies) or been diagnosed with other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
* Had an active, uncontrolled infection
* Had received any other investigational therapy within 14 days or not recovered from acute affects of the other investigational therapy
* Had received prior or current hydroxyurea or medications to reduce blast count within 24 hours before randomization
* Had received previous treatment with vosaroxin
* Pregnant or lactating
* Had any other medical, psychological, or social condition that may interfere with consent, study participation, or follow-up
* Had known HIV seropositivity

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2017
Sample size
Target
Accrual to date
Final
711
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Haematology Department, Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [6] 0 0
Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [8] 0 0
Andrew Love Cancer Center, Geelong Hospital, Barwon Health - Geelong
Recruitment hospital [9] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [10] 0 0
Department of Clinical Haematology and BMT Service, Royal Melbourne Hospital - Parkville
Recruitment hospital [11] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4029 - Brisbane
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment postcode(s) [9] 0 0
3004 - Melbourne
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment postcode(s) [11] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
West Virginia
Country [21] 0 0
Austria
State/province [21] 0 0
Graz
Country [22] 0 0
Austria
State/province [22] 0 0
Innsbruck
Country [23] 0 0
Austria
State/province [23] 0 0
Salzburg
Country [24] 0 0
Austria
State/province [24] 0 0
Wien
Country [25] 0 0
Belgium
State/province [25] 0 0
Antwerpen
Country [26] 0 0
Belgium
State/province [26] 0 0
Brugge
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussels
Country [28] 0 0
Belgium
State/province [28] 0 0
Leuven
Country [29] 0 0
Belgium
State/province [29] 0 0
Roeselare
Country [30] 0 0
Canada
State/province [30] 0 0
British Columbia
Country [31] 0 0
Canada
State/province [31] 0 0
New Brunswick
Country [32] 0 0
Canada
State/province [32] 0 0
Nova Scotia
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
Czechia
State/province [35] 0 0
Srobarova
Country [36] 0 0
Czechia
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Brno
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Czechia
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Hradec Kralove
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France
State/province [38] 0 0
Lille Cedex
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France
State/province [39] 0 0
Angers Cedex 01
Country [40] 0 0
France
State/province [40] 0 0
Bobigny
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France
State/province [41] 0 0
Le Chesnay
Country [42] 0 0
France
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Marseille
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France
State/province [43] 0 0
Nantes
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France
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Pessac
Country [45] 0 0
France
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Pierre Benite
Country [46] 0 0
France
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Toulouse
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Germany
State/province [47] 0 0
Duisburg
Country [48] 0 0
Germany
State/province [48] 0 0
Frankfurt
Country [49] 0 0
Germany
State/province [49] 0 0
Hamburg
Country [50] 0 0
Germany
State/province [50] 0 0
Hannover
Country [51] 0 0
Germany
State/province [51] 0 0
Heilbronn
Country [52] 0 0
Germany
State/province [52] 0 0
Kiel
Country [53] 0 0
Germany
State/province [53] 0 0
Leipzig
Country [54] 0 0
Germany
State/province [54] 0 0
Muenster
Country [55] 0 0
Germany
State/province [55] 0 0
Munich
Country [56] 0 0
Hungary
State/province [56] 0 0
Debrecen
Country [57] 0 0
Hungary
State/province [57] 0 0
Gyor
Country [58] 0 0
Hungary
State/province [58] 0 0
Kaposvar
Country [59] 0 0
Hungary
State/province [59] 0 0
Szeged
Country [60] 0 0
Italy
State/province [60] 0 0
Brindisi
Country [61] 0 0
Italy
State/province [61] 0 0
Ferrara
Country [62] 0 0
Italy
State/province [62] 0 0
Genova
Country [63] 0 0
Italy
State/province [63] 0 0
Lecce
Country [64] 0 0
Italy
State/province [64] 0 0
Napoli
Country [65] 0 0
Italy
State/province [65] 0 0
Novara
Country [66] 0 0
Italy
State/province [66] 0 0
Pavia
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Seoul
Country [68] 0 0
New Zealand
State/province [68] 0 0
Auckland
Country [69] 0 0
New Zealand
State/province [69] 0 0
Christchurch
Country [70] 0 0
New Zealand
State/province [70] 0 0
Hamilton
Country [71] 0 0
New Zealand
State/province [71] 0 0
Palmerston North
Country [72] 0 0
Poland
State/province [72] 0 0
Gdansk
Country [73] 0 0
Poland
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Poznan
Country [74] 0 0
Poland
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Wroclaw
Country [75] 0 0
Spain
State/province [75] 0 0
Barcelona
Country [76] 0 0
Spain
State/province [76] 0 0
Madrid
Country [77] 0 0
Spain
State/province [77] 0 0
Palma de Mallorca
Country [78] 0 0
Spain
State/province [78] 0 0
Salamanca
Country [79] 0 0
Spain
State/province [79] 0 0
Valencia
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Blackpool
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Cambridge
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Cardiff
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Cottingham
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Leicester
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Liverpool
Country [86] 0 0
United Kingdom
State/province [86] 0 0
London
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sunesis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Linda Neuman, MD
Address 0 0
Sunesis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data of individual participants experiencing Serious Adverse Events
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01191801