- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02002936
Long Term Safety Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study
Phase I Clinical Trial of SyB C-1101 in Patients With Myelodysplastic Syndrome - Extension Study
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Kyoto, Japan
- Research Site
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Aichi
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Nagoya, Aichi, Japan
- Research Site
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Kanagawa
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Isehara, Kanagawa, Japan
- Research Site
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Miyagi
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Sendai, Miyagi, Japan
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients must satisfy the following conditions listed below.
- Patients enrolled in the study 2012002 of SyB C-1101 in Patients With Myelodysplastic Syndrome.
- Patients who were not judged as disease progression* nor progressive disease/relapse** at the end of the cycle 6 in the study 2012002. * hematologic remission according to IWG 2006 criteria ** hematologic improvement according to IWG 2006 criteria
Patients who met the continuation criteria*** after Cycle 6 week 3 (Day 22±3) in the study 2012002.
***defined in the study 2012002 protocol "4.5 Criteria for Transition to the Next Cycle "
- Patients who can be expected to survive at least three months or longer.
- Patients who have score of 0 to 2 in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS).
Patients with adequate function in major organs (heart, lungs, liver, kidneys, etc.).
- Aspartate aminotransferase (AST): no more than 3.0 times the upper boundary of the reference range at each institution
- Alanine aminotransferase (ALT): no more than 3.0 times the upper boundary of the reference range at each institution
- Total bilirubin: no more than 1.5 times the upper boundary of the reference range at each institution
- Serum creatinine: no more than 1.5 times the upper boundary of the reference range at each institution
- ECG: no abnormal findings requiring treatment
- Echocardiography: no abnormal findings requiring treatment
- Patients who personally signed an informed consent document for participation in this study.
Exclusion Criteria:
Patients who satisfy any of the following conditions after Cycle 6 week 3 (Day 22±3) in the study 2012002 will not be enrolled in the study.
- Patients with anemia caused by factors other than MDS(hemolytic anemia, gastrointestinal hemorrhage, etc.).
- Patients with obvious infectious diseases (including viral infections).
- Patients with serious complications (liver failure, renal failure, etc.).
- Patients with a complication of serious heart disease (myocardial infarction, ischemic heart disease, etc.)
- Patients with a serious gastrointestinal condition (severe or significant nausea/vomiting, diarrhea, etc.)
- Patients with serious bleeding tendencies (disseminated intravascular coagulation (DIC), internal hemorrhage, etc.).
- Ascites or pleural fluid requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of < 130 mEq/L).
- Patients with known allergy to polyethylene glycol or gelatin capsules.
- Patients with an addiction to a legal or illegal drug, or with alcohol dependency.
- Patients who are nursing, pregnant or may become pregnant, or lactating mothers.
Patients who have not consented to the following contraceptive measures. Patients will avoid sexual intercourse with sexual partners or should use the following contraceptive methods in these time periods: for male patients during the administration period of the trial and for six months after the end of administration; female patients during the administration period of the trial and until a second menstrual period is confirmed after the end of administration (or in the case of female patients with no menstrual period, for two months after the end of administration). 1) Male patients: Patients will always use a condom.
For effective contraception, it is recommended that the female partner also use the contraceptive methods for female patients. 2) Female patients: Female patients who may become pregnant should use one or more types of the following contraceptive methods. In addition, the male partner will always use a condom.
- Oral contraceptive (birth control pills)
- Intrauterine device (IUD)
- Tubal ligation
- Other patients judged to be unsuitable by an investigator or sub-investigators.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SyB C-1101
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SyB C-1101(rigosertib sodium) will be administered orally twice daily for 14 consecutive days, followed by 7-day observation period. The treatment period of 21 days (14 days of administration + 7 days of observation) constitutes 1 cycle. The dose at cycle 6 in the study 2012002 will be the dose (if needed, the dose can be reduced) at the first cycle in this study (cycle 7). From cycle 8 on, the dose of SyB C-1101 will be reduced, delayed, or discontinued according to adverse events and results of observation at the previous cycle. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: Up to 3 years
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Total number affected by any adverse events (details are presented in adverse event section)
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Up to 3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Efficacy in Hematologic Remission (IWG2006 Criteria)
Time Frame: Up to 3 years
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SD (stable disease): according to International Working Group 2006 response criteria for myelodysplastic syndrome, SD was defined as a failure to achieve "complete remission" or "partial remission," but no evidence of progression for > 8 weeks.
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Up to 3 years
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Total Efficacy in Hematologic Improvement Ratio According to IWG 2006 Criteria.
Time Frame: Up to 3 years
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NCA (not considered assessable): no evidence of HI-E (hematologic improvement-erythroid), HI-P (hematologic improvement-platelet), HI-N (hematologic improvement-neutorophil), progressive disease, or relapse.
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Up to 3 years
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Cytogenetic Response Ratio According to IWG 2006 Criteria
Time Frame: Up to 3 years
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NCA (not considered assessable): no cytogenetic response
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Up to 3 years
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Overall Survival
Time Frame: Up to 3 years
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Survived
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Up to 3 years
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Changes in Clinical Laboratory Test Results
Time Frame: Up to 3 years
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Clinically significant changes
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Up to 3 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myelodysplastic Syndrome
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Brian JonasNational Cancer Institute (NCI); Celgene; Pharmacyclics LLC.CompletedPreviously Treated Myelodysplastic Syndrome | Myelodysplastic Syndrome | Therapy-Related Myelodysplastic Syndrome | Secondary Myelodysplastic Syndrome | Refractory High Risk Myelodysplastic SyndromeUnited States
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Thomas Jefferson UniversityAbbVieRecruitingMyelodysplastic Syndrome | Recurrent Myelodysplastic Syndrome | Refractory Myelodysplastic SyndromeUnited States
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Uma BorateRecruitingTherapy-Related Myelodysplastic Syndrome | Secondary Myelodysplastic SyndromeUnited States
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University Hospital, BrestRecruitingMyelodysplastic Syndromes | Myelodysplastic Syndrome With Isolated Del(5Q) | Myelodysplastic Syndrome With Del(5Q)France
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Cyclacel Pharmaceuticals, Inc.SuspendedLeukemia | Myelodysplastic Syndrome(MDS)United States
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TJ Biopharma Co., Ltd.Recruiting
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National Heart, Lung, and Blood Institute (NHLBI)National Cancer Institute (NCI)RecruitingMyelodysplastic Syndromes (MDS)United States, Israel
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AbbVieCelgene; Genentech, Inc.CompletedMyelodysplastic Syndromes (MDS)United States, Australia, Germany
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AbbVieGenentech, Inc.Active, not recruitingMyelodysplastic Syndromes (MDS)United States, Australia, Canada, France, Germany, Italy, United Kingdom
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The First Affiliated Hospital with Nanjing Medical...UnknownMyelodysplastic Syndromes (MDS)China
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