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NeoplasmsPhase 1NCT02314884

Phase I Trial to Investigate Cafusertib Hydrochloride Monotherapy in Chinese Patients With Advanced Solid Tumours

A Phase 1 study testing Cafusertib Hydrochloride in people with Neoplasms, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

A Phase I, Open-label, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of Cafusertib Hydrochloride in Patients With Advanced Solid Tumors Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neoplasms
What is being tested?
Cafusertib Hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
Nov 2014to Feb 2016
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients age 18 years to 75 years at the time of informed consent
  • Eastern Cooperative Oncology Group performance status score of 0-2 at screening
  • Life expectancy of at least 12 weeks
  • At least one target tumor lesion has not been irradiated and can accurately be measure.
  • Patients with histologically or cytologically confirmed diagnosis of advanced solid tumors, who had failed conventional treatment, or for whom no therapy of efficacy existed.
  • Signed informed consent consistent with Chinese Good Clinical Practice.
  • Male or female patients of child-producing potential must agree to use appropriate contraceptive measures (hormones or barrier or abstinence) during the study and for 90 days after the last day of treatment, serum pregnancy test must be negative within 7 days prior to initiation of study treatment, infertile women is defined as hysterectomy, ovariotomy or menopause for at least 12 months.
  • Adequate bone marrow, renal and hepatic function parameters: ANC more than 2000/mm3, platelet count more than 100 000/mm3, hemoglobin more than 90 g/L; Total bilirubin less than 1.5 x upper limit of normal，ALT and AST less than 2.5 x upper limit of normal，less than 5.0 x upper limit of normal in case of liver metastases; serum creatinine less than 1.5 x upper limit of normal, creatinine clearance rate more than 50 ml/min (as calculated according to Cockcroft-Gault formula for GFR estimate); Relatively normal ECG (electrocardiogram), QT intervals below 450 ms (male) ,QT intervals below 470 ms (female); LVEF more than 50%.

Who cannot join

  • Uncontrolled accumulation of coelomic fluid.
  • Any anti-cancer therapy, including chemotherapy, hormonal therapy, biologic therapy or radiotherapy within 4 weeks prior to initiation of study treatment, or received nitrourea or mitomycin chemotherapy within 6 weeks prior to initiation of study treatment.
  • Side effects/toxicities of such surgery that have not recovered to CTCAE grade 1
  • Patients who can't be interrupted use drugs, which may cause QT prolongation (see annex 2)
  • Patients with meningioma or current symptomatic brain metastases
  • Co-existing malignancy or malignancies diagnosed within the last 5 years with the exception of completely removed skin basal cell carcinoma or cervical cancer in situ
Show all 17Show fewer
  • Concurrent anti-tumor therapy
  • Involved in other clinical trials less than 4 weeks prior to Day 1
  • Known hypersensitivity to more than two substances or the trial drugs and their excipients
  • Patients with serious infections
  • Patients with history of immune deficiency, including positivity to HIV antibody, or other acquired, congenital immunodeficiency disease, or history of organ transplantation
  • Known positivity to hepatitis B antigen or hepatitis C antibody
  • Patient with other serious diseases, in the investigator's opinion, can bring patients great risk. Including but not limited to the following: unstable cardiac diseases (history of myocardial infarction within 6 months prior to Day 1, New York Heart Association Class III or greater, with poorly controlled atrial fibrillation or hypertension), need long-term steroids or immunosuppressive therapy of diseases, such as rheumatoid arthritis, multiple sclerosis and systemic lupus erythematosus
  • Pregnant(positive pregnancy test) or lactating women
  • Active alcohol abuse or heavy smoker
  • A previous history of neurological or psychiatric disorders, including epilepsy or dementia
  • Subject is thought unfit for this study by investigator

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing

    Lin Shen, MD, 010-88196561, linshenpku@163.com

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Open-label, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of Cafusertib Hydrochloride in Patients With Advanced Solid Tumors

A Phase I, Open-label, Dose-escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of Cafusertib Hydrochloride in Patients With Advanced Solid Tumors

Read the detailed description

To investigate safety, tolerability of cafusertib in Chinese patients with Advanced Solid Tumors 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 advanced cancer patients. At the same time, pharmacokinetic characteristics and preliminary efficacy of cafusertib will be observed in advanced cancer patients. To determine the recommended dosage regimen for phase II.

Conditions
Neoplasms
Being tested
Cafusertib Hydrochloride
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cafusertib HydrochlorideDrug

Study groups in NCT02314884
Study groupRoleWhat they receive
Cafusertib HydrochlorideExperimentalCafusertib Hydrochloride d1q3w
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 based on the incidence of dose limiting toxicities

    Measured: 4 weeks

Secondary outcomes (6)

  1. Objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

    Measured: 6 weeks

  2. Incidence and intensity of Adverse Events according to Common Toxicity Criteria for AEs (CTCAE version 4.0)

    Measured: 6 weeks

  3. Occurrence of dose limiting toxicities (DLT)

    Measured: 4 weeks

  4. Max concentration (Cmax) of cafusertib

    Measured: 3 weeks

  5. AUC of cafusertib

    Measured: 3 weeks

  6. Elimination half-life(T1/2) of cafusertib

    Measured: 3 weeks

Timeline

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

  1. First posted11 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionDec 2015 (estimated)
  4. Study completionFeb 2016 (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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02314884
Sponsor's protocol ID
HS-10159-I-02
Status last verified
Nov 2014
First submitted
8 Dec 2014
Last updated
12 Dec 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cafusertib Hydrochloride in people with Neoplasms, 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 8 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 12 Dec 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD of cafusertib 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 NCT02314884.

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 12 Dec 2014.

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