Status:
COMPLETED
Efficacy and Safety of ON 01910.Na in Myelodysplastic Syndrome (MDS) Patients With Trisomy 8 or Classified as Intermediate-1, -2 or High Risk
Lead Sponsor:
Traws Pharma, Inc.
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will explore the efficacy and safety of a regimen of ON 01910.Na as a 48-hour continuous intravenous infusion once a week for 3 weeks of a 4-week cycle in MDS patients with Trisomy 8 or cla...
Detailed Description
This is a phase 2, study in which 14 MDS patients with Trisomy 8 or classified as Intermediate-1, -2 and High risk who meet all other inclusion/exclusion criteria will receive ON 01910.Na 800 mg/m\^2/...
Eligibility Criteria
Inclusion
- Diagnosis of MDS confirmed within 2 weeks prior to study entry according to the World Health Organization (WHO) Criteria or the French-American-British (FAB) Classification.
- Trisomy 8 cytogenetics (simple or combined to other karyotypes) or patient classified as Intermediate-1 with bone marrow blasts equal to or greater than 5%, Intermediate-2 or High Risk MDS according to the IPSS score, or Patients with peripheral blood blasts equal to or greater than 5%.
- At least one cytopenia (Absolute Neutrophil Count \< 1800/µl or Platelet Count \<100,000/µl or Hemoglobin \< 10 g/dL).
- Failure of, or insufficient response to Azacytidine or Decitabine administered for 4 to 6 cycles in patients classified as Intermediate-2 or High risk or to Erythrocyte stimulating agents (failure or insufficient response defined as transfusion dependence or Hemoglobin remaining below 10 g/dl) in Low or Intermediate-1 Risk Trisomy 8 patients.
- Failed to respond to, relapsed following, or opted not to participate in bone marrow transplantation.
- Off all other treatments for MDS (including filgrastim (G-CSF) and erythropoietin) for at least four weeks. As an exception, filgrastim (G-CSF) can be used before, during and after the protocol treatment for patients with documented febrile neutropenia (\< 500/µl).
- ECOG Performance Status 0, 1 or 2.
- Willing to adhere to the prohibitions and restrictions specified in this protocol.
- Patient (or his/her legally authorized representative) must have signed an informed consent document indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study.
Exclusion
- Anemia due to factors other than MDS (including hemolysis or gastrointestinal bleeding).
- Hypoplastic MDS (cellularity \<10%).
- Any active malignancy within the past year except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast.
- History of HIV-1 seropositivity.
- Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
- Active infection not adequately responding to appropriate therapy.
- Total bilirubin \> 1.5 mg/dL not related to hemolysis or Gilbert's disease, ALT or AST \> 2 X ULN.
- Serum creatinine \> 2.0 mg/dL or calculated creatinine clearance \< 60 ml/min/1.73 m\^2.
- Ascites requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of \<134 Meq/L).
- Women patients who are pregnant or lactating; Male patients with female sexual partners who are unwilling to follow the strict contraception requirements described in this protocol; Patients who do not agree to use adequate contraceptive \[including prescription oral contraceptives (birth control pills), contraceptive injections, intrauterine device (IUD), double-barrier method (spermicidal jelly or foam with condoms or diaphragm), contraceptive patch, or surgical sterilization\] before entry and throughout the study; Female patients with reproductive potential who do not have a negative serum beta-HCG pregnancy test at screening.
- Major surgery without full recovery or major surgery within 3 weeks of ON 01910.Na treatment start.
- Uncontrolled hypertension (defined as a systolic pressure equal to or greater than 160 mmHg and/or a diastolic pressure equal to or greater than 110 mmHg).
- New onset seizures (within 3 months prior to the first dose of ON 01910.Na) or poorly controlled seizures
- Any concurrent investigational agent or chemotherapy, radiotherapy or immunotherapy.
- Treatment with standard MDS therapies or investigational therapy within 4 weeks of starting ON 01910.Na.
- Psychiatric illness/social situations that would limit the patient's ability to tolerate and/or comply with study requirements.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00906334
Start Date
May 1 2009
End Date
November 1 2013
Last Update
June 26 2017
Active Locations (1)
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1
Stanford Cancer Center
Stanford, California, United States, 94305