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Leukemia, Myeloid, AcutePhase 1NCT02140606

Phase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)

A Phase 1 study testing Cafusertib Hydrochloride in people with Leukemia, Myeloid, Acute, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To investigate safety, tolerability of cafusertib combination with low dose cytarabine (LD-Ara-C) in Chinese patients with relapsed/refractory AML that are not eligible for conventional or intensive treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
Cafusertib Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
Not given
Where
1 siteChina
Study dates
May 2014to Dec 2015
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

  • Signed written informed consent consistent with Chinese Good Clinical Practice.
  • Male or female patients of age >/= 18 years at the time of informed consent.
  • Patients with relapsed/refractory AML ineligible for conventional or intensive treatment.
  • Eastern Cooperative Oncology Group performance status score 0 - 2 at screening.
  • Life expectancy of at least 3 months.
  • Adequate hepatic, renal and metabolic function parameters: Serum total bilirubin ≤1.5 x upper limit of normal, aspartate transaminase (AST) , alanine transaminase (ALT) ≤2.5 x upper limit of normal; Creatinine clearance rate ≥60ml/min, Serum creatinine ≤1.0 x upper limit of normal; Relatively normal ECG(electrocardiogram), QTc<450 ms(male) ,QTc<470 ms(female); LVEF>50%.
  • Patients who can comply with the trial and follow-up procedures.

Who cannot join

  • Patients had received cafusertib hydrochloride or other PLK inhibitors.
  • Patients with APL.
  • Patients with central nervous system leukemia.
  • Need to continue using cytokine therapy at screening.
  • Patients participated in other clinical trials within 4 weeks prior to enrollment.
  • Patient with severe infection.
Show all 13Show fewer
  • Patients with myocardial infarction had occurred within six months prior to enrollment.
  • Severe heart disease, including NYHA class II cardiac dysfunction and above.
  • Patients with HIV infection or acute and chronic viral hepatitis.
  • Severe gastrointestinal disorders (bleeding, infection, obstruction or greater than grade 1 diarrhea).
  • A previous history of neurological or psychiatric disorders, including epilepsy or dementia.
  • Concomitant medications with CYP3A4 inhibitors, inducers or substrates; Women pregnant or breast feeding.
  • Subject is thought unfit for this study by investigator.

Trial locations and contacts

1 site in 1 country.

Jianxiang Wang contact

022 239099120

China1 site, 1 recruiting

  • Hospital of Blood Diseases, Chinese Academy of Medical Sciences

    Tianjin, 300020

    Jianxiang Wang

    Recruiting

Other trials in China

About this study

Official title: An Open Phase I Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous Cafusertib Hydrochloride in Combination With Subcutaneous Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)

To investigate safety, tolerability of cafusertib combination with low dose cytarabine (LD-Ara-C) in Chinese patients with relapsed/refractory AML that are not eligible for conventional or intensive treatment. The dose of cafusertib will be escalated to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cafusertib in combination with LD-Ara-C in AML patients. At the same time, pharmacokinetic characteristics and preliminary efficacy of cafusertib will be observed in AML patients. To determine the recommended dosage regimen for phase II.

Being tested
Cafusertib Hydrochloride
Keywords
AML, phase1, MTD, Cafusertib
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.

  • Cafusertib HydrochlorideDrug

    Drug: Cafusertib Hydrochloride (d1 and 15) Cafusertib (d1 and 15 - one hour iv.v) Drug: Cytarabine Cytarabine 2 x 20 mg/d s.c. d1-15.

Study groups in NCT02140606
Study groupRoleWhat they receive
Cafusertib Hydrochloride + CytarabineExperimentalCafusertib (d1 and 15 - one hour iv.) + LD ARA C 2x20 mg/d s.c. Patient to receive escalating dose of cafusertib hydrochloride.
Receives: Drug: Cafusertib Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD of cafusertib in combination with LDAraC based on the incidence of dose limiting toxicities

    Measured: 4 weeks

Secondary outcomes (4)

  1. Efficacy (complete remission, CR; complete remission with incomplete blood count recovery, Cri; Partial remission (PR))

    Measured: minimum 4 weeks, maximum n.a.

  2. Incidence and intensity of adverse events graded according to CTCAE (version 4.0)

    Measured: minimum 4 weeks, maximum n.a.

  3. Incidence of dose limiting toxicity (DLT)

    Measured: 4 weeks

  4. Pharmacokinetics of cafusertib

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionDec 2015 (estimated)

Resources

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
Randomised
Intervention model
Single group
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02140606
Sponsor's protocol ID
HS-10159-I-01
Status last verified
May 2014
First submitted
12 May 2014
Last updated
16 May 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cafusertib Hydrochloride in people with Leukemia, Myeloid, Acute, run by Jiangsu Hansoh 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 7 inclusion and 13 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 16 May 2014. 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 Jianxiang Wang (022 239099120), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD of cafusertib in combination with LDAraC based on the incidence of dose limiting toxicities (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02140606.

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 16 May 2014.

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