Acute Myeloid LeukemiaPhase 1NCT02859948
A Study of SKLB1028 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
A Phase 1 study testing SKLB1028 in people with Acute Myeloid Leukemia, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
Patients will receive oral SKLB1028 for 28 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- SKLB1028
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be provided.
- Males and females age ≥ 18 years;
- Histopathologically documented primary or secondary AML, as defined by WHO criteria, confirmed by pathology review at treating institution, meeting at least one of the following:
- Refractory to at least 1 cycle of induction chemotherapy, or
- Relapsed after at least 1 cycle of induction chemotherapy, or
- Patient is not, according to the clinical judgment of the Principal Investigator, a candidate for induction chemotherapy due to age, comorbidity, or other factors;
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
- In the absence of rapidly progressing disease, the interval from prior treatment to time of SKLB1028 administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents;
- Serum creatinine ≤1.5 × ULN;
- Total serum bilirubin ≤ 1.5 × ULN unless considered due to Gilbert's syndrome or leukemic organ involvement;
- Serum AST or ALT ≤ 3.0 × ULN unless considered due to leukemic organ involvement;
- Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study;
Who cannot join
- Histologic diagnosis of acute promyelocytic leukemia;
- Clinically active central nervous system leukemia;
- Persistent clinically significant toxicity from prior chemotherapy that is Grade 2 or higher;
- Bone marrow transplant within 100 days prior to study;
- Active, uncontrolled infection;
- Major surgery within 4 weeks prior to study;
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- Radiation therapy within 4 weeks prior to study;
- Left ventricular ejection fraction ≤1 × ULN,or﹤50%. Clinically significant ECG QTc prolongation (Male: >450ms, Female: >470ms).Significant cardiac disease.
- Human immunodeficiency virus positivity;
- Active hepatitis B or C or other active liver disease;
- Women who are pregnant, lactating;
- Medical condition, serious intercurrent illness, or other extenuating circumstance that, in the judgment of the Principal Investigator, could jeopardize patient safety or interfere with the objectives of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital，Sichuan University
Chengdu, Sichuan
Ting Liu, Dr., 86-028-85422364, liuting@scu.edu.cn
About this study
Official title: Phase I Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SKLB1028 When Administered Daily to Patients With Relapsed or Refractory Acute Myeloid Leukemia
Patients will receive oral SKLB1028 for 28 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.
Read the detailed description
It is open-label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered SKLB1028 as a single agent given daily for 28 days. Cohorts of 3 patients receive SKLB1028 until dose limiting toxicity is noted (DLT). At that point cohorts will expand to 6 patients until MTD is determined. Patients not experiencing DLT or significant disease progression could continue receiving SKLB1028 up to 1 year.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- SKLB1028
- Keywords
- AML
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKLB1028Drug
SKLB1028 capsules in six doses beginning at 20 mg and rising to 200 mg.
| Study group | Role | What they receive |
|---|---|---|
| SKLB1028 | Experimental | SKLB1028 capsules in six doses beginning at 20 mg and rising to 200 mg. Receives: Drug: SKLB1028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Incidence of dose limiting toxicity (DLT)and Adverse Event (AE)
Measured: 28 Days
Secondary outcomes (11)
Maximum serum concentration (Cmax)
Measured: 28 Days
Area under the plasma concentration-time curve (AUC) from time zero to the time point of t (AUC0-tn)
Measured: 28 Days
Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
Measured: 28 Days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 28 Days
Apparent volume of distribution at equilibrium after oral administration（Vss/F）
Measured: 28 Days
Plasma Decay Half-Life (t1/2z)
Measured: 28 Days
Apparent Oral Clearance (CLz/F)
Measured: 28 Days
Average plasma or serum concentration(Cav)
Measured: 28 Days
changes in FLT3 mutation status in plasma
Measured: 28 Days
Rate of Complete Remission (CR)
Measured: 28 Days
Rate of partial remission (PR)
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ting Liu, Dr., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859948
- Sponsor's protocol ID
- 1028201601/PRO
- Status last verified
- Jun 2016
- First submitted
- 28 Jun 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Open-Label, Sequential Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SKLB1028 When Administered Daily to Patients With Relapsed or Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT02859948
- Acronym / sponsor ID
- 1028201601/PRO
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 9 Aug 2016 (estimated)
- 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.
Patients will receive oral SKLB1028 for 28 days to study the side effects, tolerability and best dose for treating relapsed or refractory acute myeloid leukemia With FLT3 Mutations.
Detailed description
It is open-label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered SKLB1028 as a single agent given daily for 28 days. Cohorts of 3 patients receive SKLB1028 until dose limiting toxicity is noted (DLT). At that point cohorts will expand to 6 patients until MTD is determined. Patients not experiencing DLT or significant disease progression could continue receiving SKLB1028 up to 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SKLB1028 | Experimental | Drug: SKLB1028SKLB1028 capsules in six doses beginning at 20 mg and rising to 200 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Written informed consent must be provided.
- Males and females age ≥ 18 years;
- Histopathologically documented primary or secondary AML, as defined by WHO criteria, confirmed by pathology review at treating institution, meeting at least one of the following:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
- In the absence of rapidly progressing disease, the interval from prior treatment to time of SKLB1028 administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents;
Key exclusion criteria (12 listed)
- Histologic diagnosis of acute promyelocytic leukemia;
- Clinically active central nervous system leukemia;
- Persistent clinically significant toxicity from prior chemotherapy that is Grade 2 or higher;
- Bone marrow transplant within 100 days prior to study;
- Active, uncontrolled infection;
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 |
|---|---|---|
| SKLB1028SKLB1028 capsules in six doses beginning at 20 mg and rising to 200 mg. | Drug | SKLB1028 |
Primary outcome
Safety: Incidence of dose limiting toxicity (DLT)and Adverse Event (AE)
Time frame: 28 Days
11 secondary outcomes
Maximum serum concentration (Cmax)
Time frame: 28 Days
Area under the plasma concentration-time curve (AUC) from time zero to the time point of t (AUC0-tn)
Time frame: 28 Days
Area under the plasma concentration-time curve (AUC) from time zero to infinity (AUC0-inf)
Time frame: 28 Days
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 28 Days
Apparent volume of distribution at equilibrium after oral administration（Vss/F）
Time frame: 28 Days
Plasma Decay Half-Life (t1/2z)
Time frame: 28 Days
Apparent Oral Clearance (CLz/F)
Time frame: 28 Days
Average plasma or serum concentration(Cav)
Time frame: 28 Days
changes in FLT3 mutation status in plasma
Time frame: 28 Days
Rate of Complete Remission (CR)
Time frame: 28 Days
Rate of partial remission (PR)
Time frame: 28 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
- Individual participant dataSharing planned: No
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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.
Ting Liu, Dr. principal investigator
West China 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 SKLB1028 in people with Acute Myeloid Leukemia, run by CSPC ZhongQi Pharmaceutical Technology 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 12 inclusion and 12 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 9 Aug 2016. 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 Ting Liu, Dr. (86-028-85422364, liuting@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence of dose limiting toxicity (DLT)and Adverse Event (AE) (time frame: 28 Days). 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 9 Aug 2016.