Refractory Multiple MyelomaPhase 1NCT03618602
Safety, Pharmacokinetics and Efficacy Study of Bisthianostat in Refractory or Recurrent Multiple Myeloma Patients
A Phase 1 study testing Bisthianostat in people with Refractory Multiple Myeloma and Recurrent Multiple Myeloma, run by Shanghai Theorion Pharmaceutical Co Ltd. at 1 site in China.
Trial summary
This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and efficacy of Bisthianostat in refractory or recurrent multiple myeloma patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory Multiple Myeloma, Recurrent Multiple Myeloma
- What is being tested?
- Bisthianostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2018to Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as stage II or III (Durie-Salmon Staging System) multiple myeloma with disease progression or recurrence after at least two cycles of systemic antimyeloma treatment.
- Serum M protein≥ 5.0g / L, or urine M protein ≥ 200mg / 24h, or serum free light chain ≥ 200mg / L.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
- Expected survival of ≥3 months.
- Female participants of childbearing potential should have negative urine pregnancy test in screening period (accept previous test result within 14 days before screening), and must agree to adopt effective contraceptive measures within 14 days before receiving first dose of study drug, during the treatment period and within 28 days after final dose of study drug.
- Male participants must agree to adopt effective contraceptive measures and not allowed to donate sperms during the treatment period, and within 28 days after final dose of study drug.
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- Hemoglobin ≥ 80 g/L, Platelet≥50×109/L (50,000/mm3), Absolute Neutrophil Count≧1.0×109/L (1000 cells/mm3), Prothrombin time(PT) and activated partial thromboplastin time ≤ 2 x Upper Limit of Normal (ULN)
- AST or ALT ≤ 1.5 x ULN, total bilirubin≤ 1.5 x ULN;
- Serum Creatinine ≤ 1.5 x ULN, glomerular filtration rate≥ 50 ml/min;
- NYHA Class I or II
- Written informed consent obtained prior to participation in the study
Who cannot join
- Pregnant or lactating women.
- Non-secretory multiple myeloma patients.
- Plasma cell leukemia patients.
- Received any anti-cancer medication or experimental drugs against multiple myeloma within 1 week before first dose of bisthianostat, any experimental treatment other than medication (eg. leukocyte donor/monocyte infusion) within 56 days before first dose of bisthianostat. Participation in any other drug or medical devices within 56 days before the study.
- Stem cell transplant planned on the following 28 days.
- Uncontrolled hypercalcemia after treatments, eg. saline infusion.
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- Renal insufficiency required hemodialysis or peritoneal dialysis.
- NCI-CTCAE grade 2 Peripheral Neuropathy.
- Serious heart disease in the past 6 months, including angina requiring surgery, uncontrolled hypertension after anti-hypertensive treatments (Systolic blood pressure> 160 mmHg, Diastolic blood pressure>90mmHg); Myocardial infarction; Grade II-IV congestive heart failure; unstable angina.
- HIV, HCV or HBV (HBV-DNA > 20 IU/mL) infection.
- Patients with any other prior malignancy, except for skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, skin squamous cell carcinoma that have been treated and controlled.
- Imaging evidences show tumors have involved main blood vessels and nerves.
- Patients with significant central nervous system lesions.
- Patients with mental illness.
- Patients with history of alcohol or drug abuse, patients with allergy to the active ingredient or excipients of study drug, and patients who are unable or unwilling to receive the intravenous administration.
- Active infection (Bacteria, fungi, virus etc), fever with body temperature > 38 ℃ for reasons unknown.
- Other situations that investigator considers it's inappropriate for patients to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Hou Jian, 00862158752345, hou.jian@renji.com
About this study
Official title: A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Bisthianostat in Refractory or Recurrent Multiple Myeloma Patients
This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and efficacy of Bisthianostat in refractory or recurrent multiple myeloma patients.
Read the detailed description
This is a first-in-human, single center, open-label, single arm, dose escalating phase I study. This study will be conducted in 3 parts.
Phase A : Patients will receive single dose of bisthianostat to evaluate the single-dose pharmacokinetics and safety.
Phase B: After single-dose phase, patients will receive multiple dose bisthianostat for 4 weeks on day 1,4,11,14,18,21,25,28 to evaluate the multiple-dose pharmacokinetics and safety
Phase C: Patients will continue on the study if they benefit from the drug and not experience any serious side effects.
- Being tested
- Bisthianostat
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisthianostatDrug
Also called CF367-C, CFH367-C, CF367, PY-1
Bisthianostat is a histone deacetylase inhibitor (HDAC inhibitor) for the treatment of multiple myeloma.
| Study group | Role | What they receive |
|---|---|---|
| 100mg Bisthianostat | Experimental | 100mg starting dose taken orally on Day 1, 4,7,11,14,18,21,25 and 28 of each cycle(4 weeks). Receives: Drug: Bisthianostat |
| 200mg Bisthianostat | Experimental | 200mg Bisthianostat taken orally on Day 1, 4,7,11,14,18,21,25 and 28 of each cycle(4 weeks). Receives: Drug: Bisthianostat |
| 400mg Bisthianostat | Experimental | 400mg Bisthianostat taken orally on Day 1, 4,7,11,14,18,21,25 and 28 of each cycle(4 weeks). Receives: Drug: Bisthianostat |
| 600mg Bisthianostat | Experimental | 600mg Bisthianostat taken orally on Day 1, 4,7,11,14,18,21,25 and 28 of each cycle(4 weeks). Receives: Drug: Bisthianostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of Bisthianostat
To determine the maximum tolerated dose of Bisthianostat in refractory or recurrent multiple myeloma patients.
Measured: Up to 24 months
Treatment-related adverse events considered as dose-limiting toxicity
To evaluate the severity of treatment-related AEs considered as dose-limiting toxicity.
Measured: During the first cycle (4 weeks)
Secondary outcomes (7)
Peak Plasma Concentration (Cmax)
To determine the Peak Plasma Concentration of Bisthianostat.
Measured: During the first cycle (4 weeks)
Area under the plasma concentration versus time curve (AUC)
To determine the Area under the plasma concentration versus time curve of Bisthianostat.
Measured: During the first cycle (4 weeks)
Time of Peak Concentration (Tmax)
To determine the time of peak concentration of Bisthianostat.
Measured: During the first cycle (4 weeks)
Half life (T1/2)
To determine the half-life of Bisthianostat.
Measured: During the first cycle (4 weeks)
Objective Response Rate
To evaluate the objective response rate in refractory or recurrent myeloma patients after bisthianostat treatments.
Measured: Up to 1 month after last dose
Incidence of adverse events related to treatments
To evaluate the incidence of adverse events that are related to treatments in refractory or recurrent myeloma patients
Measured: Up to 1 month after last dose
Incidence of laboratory abnormalities related to treatments
To evaluate the incidence of laboratory abnormalities that are related to treatments in refractory or recurrent myeloma patients
Measured: Up to 1 month after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start25 Apr 2018
- Primary completionApr 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Multiple MyelomaStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Theorion Pharmaceutical Co Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Institute of Materia Medica, Chinese Academy of Sciences
- Responsible party
- Sponsor
- Investigators
- Jian Hou, MD, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618602
- Sponsor's protocol ID
- CH-020PI
- Status last verified
- Sep 2019
- First submitted
- 13 Jul 2018
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Bisthianostat in Refractory or Recurrent Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT03618602
- Acronym / sponsor ID
- CH-020PI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Theorion Pharmaceutical Co Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Institute of Materia Medica, Chinese Academy of Sciences
- Study start
- 25 Apr 2018 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human study to investigate the safety, tolerability, pharmacokinetics, and efficacy of Bisthianostat in refractory or recurrent multiple myeloma patients.
Detailed description
This is a first-in-human, single center, open-label, single arm, dose escalating phase I study. This study will be conducted in 3 parts.
Phase A : Patients will receive single dose of bisthianostat to evaluate the single-dose pharmacokinetics and safety.
Phase B: After single-dose phase, patients will receive multiple dose bisthianostat for 4 weeks on day 1,4,11,14,18,21,25,28 to evaluate the multiple-dose pharmacokinetics and safety
Phase C: Patients will continue on the study if they benefit from the drug and not experience any serious side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 100mg Bisthianostat | Experimental | Drug: Bisthianostat100mg starting dose taken orally on Day 1, 4,7,11,14,18,21,25 and 28 of each cycle(4 weeks). |
| 200mg Bisthianostat | Experimental | Drug: Bisthianostat200mg Bisthianostat taken orally on Day 1, 4,7,11,14,18,21,25 and 28 of each cycle(4 weeks). |
| 400mg Bisthianostat | Experimental | Drug: Bisthianostat400mg Bisthianostat taken orally on Day 1, 4,7,11,14,18,21,25 and 28 of each cycle(4 weeks). |
| 600mg Bisthianostat | Experimental | Drug: Bisthianostat600mg Bisthianostat taken orally on Day 1, 4,7,11,14,18,21,25 and 28 of each cycle(4 weeks). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Diagnosed as stage II or III (Durie-Salmon Staging System) multiple myeloma with disease progression or recurrence after at least two cycles of systemic antimyeloma treatment.
- Serum M protein≥ 5.0g / L, or urine M protein ≥ 200mg / 24h, or serum free light chain ≥ 200mg / L.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
- Expected survival of ≥3 months.
- Female participants of childbearing potential should have negative urine pregnancy test in screening period (accept previous test result within 14 days before screening), and must agree to adopt effective contraceptive measures within 14 days before receiving first dose of study drug, during the treatment period and within 28 days after final dose of study drug.
Key exclusion criteria (17 listed)
- Pregnant or lactating women.
- Non-secretory multiple myeloma patients.
- Plasma cell leukemia patients.
- Received any anti-cancer medication or experimental drugs against multiple myeloma within 1 week before first dose of bisthianostat, any experimental treatment other than medication (eg. leukocyte donor/monocyte infusion) within 56 days before first dose of bisthianostat. Participation in any other drug or medical devices within 56 days before the study.
- Stem cell transplant planned on the following 28 days.
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 |
|---|---|---|
| BisthianostatAlso: CF367-C, CFH367-C, CF367, PY-1Bisthianostat is a histone deacetylase inhibitor (HDAC inhibitor) for the treatment of multiple myeloma. | Drug | 100mg Bisthianostat, 200mg Bisthianostat, 400mg Bisthianostat, 600mg Bisthianostat |
Primary outcome
Maximum tolerated dose of Bisthianostat
Time frame: Up to 24 months
To determine the maximum tolerated dose of Bisthianostat in refractory or recurrent multiple myeloma patients.
Treatment-related adverse events considered as dose-limiting toxicity
Time frame: During the first cycle (4 weeks)
To evaluate the severity of treatment-related AEs considered as dose-limiting toxicity.
7 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: During the first cycle (4 weeks)
Area under the plasma concentration versus time curve (AUC)
Time frame: During the first cycle (4 weeks)
Time of Peak Concentration (Tmax)
Time frame: During the first cycle (4 weeks)
Half life (T1/2)
Time frame: During the first cycle (4 weeks)
Objective Response Rate
Time frame: Up to 1 month after last dose
Incidence of adverse events related to treatments
Time frame: Up to 1 month after last dose
Incidence of laboratory abnormalities related to treatments
Time frame: Up to 1 month after last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
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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.
Jian Hou, MD principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bisthianostat in people with Refractory Multiple Myeloma and Recurrent Multiple Myeloma, run by Shanghai Theorion Pharmaceutical Co Ltd. at 1 site in China.
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 11 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: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Hou, MD (00862168383144, houjian@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose of Bisthianostat (time frame: Up to 24 months). The study lists 2 primary outcomes in all. 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 19 Sep 2019.