A study which compares Rigosertib with standard of care treatment in patients with ineffective production of blood cells (myelodysplastic syndrome) who have undergone treatment with azacitidine or decitabine without success
- Conditions
- Myelodysplastic SyndromeMedDRA version: 18.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-001476-22-FR
- Lead Sponsor
- Onconova Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 225
a. 18-79 years of age;
b. Disease classified as follows:
• RAEB-1 per World Health Organization (WHO) MDS criteria (5% to 9% BM blasts)
• RAEB-2 per WHO MDS criteria (10% to 19% BM blasts)
• RAEB-t per modified French-American-British (FAB) classification (20% to 30% BM blasts)
c. Diagnosis of MDS confirmed within 8 weeks prior to the Screening Visit
d. At least one cytopenia (ANC < 1800/µL or platelet count < 100,000/µL or hemoglobin [Hgb] < 10 g/dL)
e. Progression (according to 2006 IWG criteria) at any time after initiation of AZA or DEC treatment
or
Failure to achieve complete or partial response or hematological improvement (HI) (according to 2006 IWG) after at least six 4-week cycles of AZA or either four 4-week or four 6-week cycles of DEC administered
or
Relapse after initial complete or partial response or HI (according to 2006 IWG criteria)
or
Intolerance to AZA or DEC
f. Duration of prior HMA therapy = 9 months
g. Last dose of AZA or DEC within 6 months before the planned date of randomization; however, must be off these treatments for = 4 weeks before randomization
h. Has failed to respond to, relapsed following, not eligible for, or opted not to participate in allogeneic stem cell transplantation
i. Off all treatments for MDS (including AZA and DEC) for = 4 weeks before randomization; growth factors (G-CSF, erythropoietin and thrombopoietin) and transfusions are allowed before and during the study as clinically indicated
j. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
k. Willing to adhere to the prohibitions and restrictions specified in this protocol
l. Patient (or patient’s legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 113
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112
a. Previous participation in a clinical study of IV or oral rigosertib; patients who failed screening for other rigosertib studies may be screened for participation in this study
b. Eligible to receive induction chemotherapy, such as 7-10 days of cytosine arabinoside plus 2-3 days of an anthracycline, or high-dose cytarabine (HDAC)
c. Eligible to receive allogeneic stem cell transplantation
d. Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast
e. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure or unstable angina pectoris
f. Active infection not adequately responding to appropriate therapy
g. Total bilirubin =1.5 mg/dL not related to hemolysis or Gilbert’s disease
h. Alanine transaminase (ALT)/aspartate transaminase (AST) =2.5 x upper limit of normal (ULN)
i. Serum creatinine =2.0 mg/dL
j. Known HIV, hepatitis B or hepatitis C
k. Uncorrected hyponatremia (defined as serum sodium value of <130 mEq/L)
l. Female patients of child-bearing potential and male patients with partners of child-bearing potential who are unwilling to follow strict contraception requirements before entry and throughout the study, up to and including the 30-day non-treatment follow-up period
m. Female patients of child-bearing potential who are breast-feeding or have a positive blood betahuman chorionic gonadotropin (ßHCG) pregnancy test at Screening
n. Major surgery without full recovery or major surgery within 3 weeks before planned randomization
o. Uncontrolled hypertension
p. New onset seizures (within 3 months before planned randomization) or poorly controlled seizures
q. Any other concurrent investigational agent or chemotherapy, radiotherapy, immunotherapy, or corticosteroids (prednisone up to 20 mg/day or its equivalent is permitted for chronic conditions)
r. Treatment with cytarabine at any dose, lenalidomide, or any other therapy targeted to the treatment of MDS (other than growth factors and other supportive care measures) within 4 weeks of planned randomization
s. Investigational therapy within 4 weeks of planned randomization
t. Psychiatric illness or social situation that would limit the patient’s ability to tolerate and/or comply with study requirements.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method