Myelodysplastic SyndromePhase 1NCT02002936
Long Term Safety Study of SyB C-1101 in Patients With Recurrent/Relapsed or Refractory Myelodysplastic Syndrome (MDS) - Extension Study
A Phase 1 study testing SyB C-1101 in people with Myelodysplastic Syndrome, run by SymBio Pharmaceuticals at 4 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- SyB C-1101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 4 sitesJapan
- Study dates
- Aug 2013to Dec 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 15Show fewer
- 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.
Who cannot join
- 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.)
Show all 17Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Research Site
Isehara, Kanagawa
Research Site
Kyoto, Kyoto
Research Site
Nagoya, Aichi-ken
Research Site
Sendai, Miyagi
About this study
Official title: Phase I Clinical Trial of SyB C-1101 in Patients With Myelodysplastic Syndrome - Extension Study
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.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- SyB C-1101
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyB C-1101Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| SyB C-1101 | Experimental | Not described Receives: Drug: SyB C-1101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Total number affected by any adverse events (details are presented in adverse event section)
Measured: Up to 3 years
Secondary outcomes (5)
Total Efficacy in Hematologic Remission (IWG2006 Criteria)
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.
Measured: Up to 3 years
Total Efficacy in Hematologic Improvement Ratio According to IWG 2006 Criteria.
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.
Measured: Up to 3 years
Cytogenetic Response Ratio According to IWG 2006 Criteria
NCA (not considered assessable): no cytogenetic response
Measured: Up to 3 years
Overall Survival
Survived
Measured: Up to 3 years
Changes in Clinical Laboratory Test Results
Clinically significant changes
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Myelodysplastic SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- SymBio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katsuhisa Goto, Study director, SymBio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02002936
- Sponsor's protocol ID
- 2012004
- Status last verified
- Jan 2017
- First submitted
- 1 Dec 2013
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of SyB C-1101 in Patients With Myelodysplastic Syndrome - Extension Study
- ClinicalTrials.gov ID
- NCT02002936
- Acronym / sponsor ID
- 2012004
- Conditions
- Myelodysplastic Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- SymBio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Posted 12 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SyB C-1101 | Experimental | Drug: SyB C-1101 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 "
Key exclusion criteria (17 listed)
- 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.)
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 |
|---|---|---|
| SyB C-1101SyB 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. | Drug | SyB C-1101 |
Primary outcome
Adverse Events
Time frame: Up to 3 years
Total number affected by any adverse events (details are presented in adverse event section)
5 secondary outcomes
Total Efficacy in Hematologic Remission (IWG2006 Criteria)
Time frame: Up to 3 years
Total Efficacy in Hematologic Improvement Ratio According to IWG 2006 Criteria.
Time frame: Up to 3 years
Cytogenetic Response Ratio According to IWG 2006 Criteria
Time frame: Up to 3 years
Overall Survival
Time frame: Up to 3 years
Changes in Clinical Laboratory Test Results
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Myelodysplastic Syndrome
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
High Grade Myelodysplastic Syndromes
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Katsuhisa Goto study director
SymBio Pharmaceuticals
4 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 SyB C-1101 in people with Myelodysplastic Syndrome, run by SymBio Pharmaceuticals at 4 sites in Japan.
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 15 inclusion and 17 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 12 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adverse Events (time frame: Up to 3 years). 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 23 Feb 2017.