Leukemia, Lymphocytic, AcutePhase 1NCT00246662
Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies
A Phase 1 study testing Vosaroxin in people with Leukemia, Lymphocytic, Acute and Leukemia, Nonlymphocytic, Acute, run by Sunesis Pharmaceuticals at 5 sites in United States.
Trial summary
This study primarily determined the safety and tolerability of escalating doses of vosaroxin (SNS-595) in 2 dose schedules, and assessed the PK profile of vosaroxin and defined a recommended dose regimen for Phase 2 studies. Secondarily the study assessed potential biomarkers and antileukemic activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Acute, Leukemia, Nonlymphocytic, Acute, Leukemia, Myeloid, Chronic
- 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
- 75 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Nov 2005to Apr 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Able to understand and willing to sign a written informed consent document
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, 0r 2
- Received less than or equal to 3 induction/re-induction regimens for disease(s) defined by the protocol
- Must have relapsed or refractory leukemia for which no standard therapies are expected to result in a durable remission; patients who have not received prior treatment who have either refused or, in the opinion of the Investigator, are not able to tolerate, standard therapy may be included.
Who cannot join
- Prior exposure to SNS-595 (vosaroxin)
- Pregnant or breastfeeding
- Women of childbearing potential or male partners of women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards
- Any evidence of active central nervous system (CNS) leukemia
- Any evidence of acute or chronic graft-versus-host disease
- Has active cancer (other than that which is defined by the inclusion criteria for this protocol), except for skin cancer (excluding melanoma)
Show all 14Show fewer
- Laboratory values outside normal or reasonable reference range specified by the protocol
- Liver function and kidney function outside limits specified by the protocol
- Not yet recovered from side effects of previous cancer therapy
- Myocardial infarction, cerebrovascular accident/transient ischemic attack (TIA) or thromboembolic event (deep vein thrombosis or pulmonary embolus) within 6 months before the first SNS-595 dose
- Requires kidney dialysis (hemodialysis or peritoneal)
- Received an investigational agent within 14 days before Cycle 1, Day 1
- Prior pelvic radiation therapy or radiation to greater than or equal to 25% of bone marrow reserve (palliative radiation is not excluded as long as it does not exceed greater than or equal to 25% of bone marrow reserve)
- Any other medical (uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia), psychological, or social condition that, in the opinion of the Principal Investigator, would contraindicate the patient's participation in the clinical trial due to safety or compliance with study procedures
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, 87196
Johns Hopkins Hospital
Baltimore, Maryland, 21231
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Cancer Center
Indianapolis, Indiana, 46202
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: Phase 1b Open-Label, Multicenter Clinical Study of the Safety and Activity of Intravenous Administration of SNS-595 in Patients With Advanced Hematologic Malignancies
This study primarily determined the safety and tolerability of escalating doses of vosaroxin (SNS-595) in 2 dose schedules, and assessed the PK profile of vosaroxin and defined a recommended dose regimen for Phase 2 studies. Secondarily the study assessed potential biomarkers and antileukemic activity.
Read the detailed description
Patients assigned to 1 of 2 schedules (A and B) in cohorts of at least 3 patients received vosaroxin (SNS-595) intravenously (IV) for up to 4 cycles: once weekly (Days 1, 8, 15 in Schedule A) or twice weekly (Days 1, 4, 8, 11 in Schedule B). Dose escalation proceeded independently for Schedule A (18 mg/m2 initially) and Schedule B (9 mg/m2 initially) in the absence of Dose-limiting Toxicity (DLT) based on a modified Fibonacci sequence. The incidence of DLT during Cycle 1 determined the maximum-tolerated dose (MTD) allowing for treatment delays of up to 14 days to resolve clinically significant abnormal laboratory values or related treatment-emergent adverse events (TEAEs) and one dose reduction of 25% in case of above. Patients with stable disease, hematologic improvement, or partial remission with stable blast counts or experiencing clinical benefit in the opinion of the investigator were eligible to receive vosaroxin for up to 4 additional cycles.
- Conditions
- Leukemia, Lymphocytic, Acute, Leukemia, Nonlymphocytic, Acute, Leukemia, Myeloid, Chronic, Myelodysplastic Syndromes
- Being tested
- Vosaroxin
- Keywords
- Leukemia, Hematologic, Blood, Cancer, Malignancy, Myelodysplastic Syndromes
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Myelodysplastic Syndromes, Leukemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VosaroxinDrug
Also called SNS-595, Voreloxin
All patients receive vosaroxin Injection
| Study group | Role | What they receive |
|---|---|---|
| Sch A (18 mg/m2 vosaroxin initially) | Experimental | Once weekly intravenous on days 1, 8, 15 up to 4 cycles Receives: Drug: Vosaroxin |
| Sch B (9 mg/m2 vosaroxin initially) | Experimental | Twice weekly intravenous administration on days 1, 4, 8, 11 up to 4 cycles Receives: Drug: Vosaroxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Measured: 6 months
Secondary outcomes (3)
Pharmacokinetic profile
Measured: 6 months
Duration of leukemia-free survival
Measured: 6 months
Anti-tumor activity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study start14 Nov 2005
- Primary completion23 Dec 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, AcuteStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunesis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Glenn Michelson, MD, Study director, Sunesis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246662
- Sponsor's protocol ID
- SPO-0004
- Status last verified
- Mar 2017
- First submitted
- 30 Jun 2005
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Aggregate data of participants experiencing Adverse Events
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1b Open-Label, Multicenter Clinical Study of the Safety and Activity of Intravenous Administration of SNS-595 in Patients With Advanced Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT00246662
- Acronym / sponsor ID
- SPO-0004
- Conditions
- Leukemia, Lymphocytic, Acute, Leukemia, Nonlymphocytic, Acute, Leukemia, Myeloid, Chronic, Myelodysplastic Syndromes
- Keywords
- Leukemia, Hematologic, Blood, Cancer, Malignancy, Myelodysplastic Syndromes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sunesis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2005
- Primary completion
- 23 Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 31 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study primarily determined the safety and tolerability of escalating doses of vosaroxin (SNS-595) in 2 dose schedules, and assessed the PK profile of vosaroxin and defined a recommended dose regimen for Phase 2 studies. Secondarily the study assessed potential biomarkers and antileukemic activity.
Detailed description
Patients assigned to 1 of 2 schedules (A and B) in cohorts of at least 3 patients received vosaroxin (SNS-595) intravenously (IV) for up to 4 cycles: once weekly (Days 1, 8, 15 in Schedule A) or twice weekly (Days 1, 4, 8, 11 in Schedule B). Dose escalation proceeded independently for Schedule A (18 mg/m2 initially) and Schedule B (9 mg/m2 initially) in the absence of Dose-limiting Toxicity (DLT) based on a modified Fibonacci sequence. The incidence of DLT during Cycle 1 determined the maximum-tolerated dose (MTD) allowing for treatment delays of up to 14 days to resolve clinically significant abnormal laboratory values or related treatment-emergent adverse events (TEAEs) and one dose reduction of 25% in case of above. Patients with stable disease, hematologic improvement, or partial remission with stable blast counts or experiencing clinical benefit in the opinion of the investigator were eligible to receive vosaroxin for up to 4 additional cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sch A (18 mg/m2 vosaroxin initially) | Experimental | Drug: VosaroxinOnce weekly intravenous on days 1, 8, 15 up to 4 cycles |
| Sch B (9 mg/m2 vosaroxin initially) | Experimental | Drug: VosaroxinTwice weekly intravenous administration on days 1, 4, 8, 11 up to 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to understand and willing to sign a written informed consent document
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, 0r 2
- Received less than or equal to 3 induction/re-induction regimens for disease(s) defined by the protocol
- Must have relapsed or refractory leukemia for which no standard therapies are expected to result in a durable remission; patients who have not received prior treatment who have either refused or, in the opinion of the Investigator, are not able to tolerate, standard therapy may be included.
Key exclusion criteria (14 listed)
- Prior exposure to SNS-595 (vosaroxin)
- Pregnant or breastfeeding
- Women of childbearing potential or male partners of women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards
- Any evidence of active central nervous system (CNS) leukemia
- Any evidence of acute or chronic graft-versus-host disease
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: SNS-595, VoreloxinAll patients receive vosaroxin Injection | Drug | Sch A (18 mg/m2 vosaroxin initially), Sch B (9 mg/m2 vosaroxin initially) |
Primary outcome
Safety and tolerability
Time frame: 6 months
3 secondary outcomes
Pharmacokinetic profile
Time frame: 6 months
Duration of leukemia-free survival
Time frame: 6 months
Anti-tumor activity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2017.
- Individual participant dataSharing planned: No. Aggregate data of participants experiencing 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.
Glenn Michelson, MD study director
Sunesis Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vosaroxin in people with Leukemia, Lymphocytic, Acute and Leukemia, Nonlymphocytic, Acute, run by Sunesis Pharmaceuticals at 5 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 14 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 30 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and tolerability (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2017.