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Long Term Safety Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02002936
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : December 12, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
SymBio Pharmaceuticals

Brief Summary:
This is an extension study to investigate long term safety and efficacy of SyB C-1101 when orally administered every 3 weeks, twice daily for 14 consecutive days to the patients who have completed 6 cycles in the study 2012002 whose purpose is to investigate tolerability of SyB C-1101 when administered orally in patients with recurrent/relapsed or refractory myelodysplastic syndrome.

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndrome Drug: SyB C-1101 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Clinical Trial of SyB C-1101 in Patients With Myelodysplastic Syndrome - Extension Study
Study Start Date : August 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SyB C-1101 Drug: SyB C-1101

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.





Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 3 years ]
    Total number affected by any adverse events (details are presented in adverse event section)


Secondary Outcome Measures :
  1. Total Efficacy in Hematologic Remission (IWG2006 Criteria) [ Time Frame: Up to 3 years ]
    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.

  2. Total Efficacy in Hematologic Improvement Ratio According to IWG 2006 Criteria. [ Time Frame: Up to 3 years ]
    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.

  3. Cytogenetic Response Ratio According to IWG 2006 Criteria [ Time Frame: Up to 3 years ]
    NCA (not considered assessable): no cytogenetic response

  4. Overall Survival [ Time Frame: Up to 3 years ]
    Survived

  5. Changes in Clinical Laboratory Test Results [ Time Frame: Up to 3 years ]
    Clinically significant changes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must satisfy the following conditions listed below.

  1. Patients enrolled in the study 2012002 of SyB C-1101 in Patients With Myelodysplastic Syndrome.
  2. 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
  3. 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 "

  4. Patients who can be expected to survive at least three months or longer.
  5. Patients who have score of 0 to 2 in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS).
  6. 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
  7. 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.

  1. Patients with anemia caused by factors other than MDS(hemolytic anemia, gastrointestinal hemorrhage, etc.).
  2. Patients with obvious infectious diseases (including viral infections).
  3. Patients with serious complications (liver failure, renal failure, etc.).
  4. Patients with a complication of serious heart disease (myocardial infarction, ischemic heart disease, etc.)
  5. Patients with a serious gastrointestinal condition (severe or significant nausea/vomiting, diarrhea, etc.)
  6. Patients with serious bleeding tendencies (disseminated intravascular coagulation (DIC), internal hemorrhage, etc.).
  7. Ascites or pleural fluid requiring active medical management including paracentesis, or hyponatremia (defined as serum sodium value of < 130 mEq/L).
  8. Patients with known allergy to polyethylene glycol or gelatin capsules.
  9. Patients with an addiction to a legal or illegal drug, or with alcohol dependency.
  10. Patients who are nursing, pregnant or may become pregnant, or lactating mothers.
  11. 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
  12. Other patients judged to be unsuitable by an investigator or sub-investigators.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02002936


Locations
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Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Kyoto, Japan
Sponsors and Collaborators
SymBio Pharmaceuticals
Investigators
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Study Director: Katsuhisa Goto SymBio Pharmaceuticals
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Responsible Party: SymBio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02002936    
Other Study ID Numbers: 2012004
First Posted: December 6, 2013    Key Record Dates
Results First Posted: December 12, 2016
Last Update Posted: February 23, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Syndrome
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms