AzTrials
AzTrials

Advanced Breast CancerPhase 1NCT01931943

A Phase Ib Study of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer

A Phase 1 study testing selatinib ditosilate tablets in people with Advanced Breast Cancer, run by Qilu 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

Brief Description: This study is designed to evaluate the safety and tolerability of oral Selatinib Ditosilate Tablets, and explore the maximum tolerated dose (MTD) and dose-limiting toxicity in patients with advanced breast cancer. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Advanced Breast Cancer
What is being tested?
selatinib ditosilate tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
Apr 2013to Dec 2013
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 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • women aged 18-65.
  • Patients with ECOG performance status of 0 or 1.
  • Expected life-expectancy of more than 3 months.
  • Patients must have histologically or cytologically confirmed breast cancer. Either the primary breast tumor or the metastasis must overexpress HER2; acceptable methods of measurement of HER2 expression include immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH); tumors tested by IHC must be 3+ positive for HER2 overexpression immunohistochemistry ; tumors tested by FISH must be positive.
  • Prior Herceptin therapy is discontinued because of disease progression or patients can not afford for Herceptin therapy.
  • patients with at least one measurable lesion (RECIST1.1 criteria).
Show all 12Show fewer
  • Hematology： WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥100×109/L，HB≥90g/L;
  • Biochemistry： Serum bilirubin≤1.5 times upper limit of normal (ULN),AST and ALT ≤1.5 times ULN; creatinine and urea nitrogen≤1.5 times ULN; LVEF≥50%, ECG normal, and Fridericia corrected QT(QTcF)<470ms.
  • patients receiving damage caused by other therapeutic has been restored, the interval more than six weeks since the last receiving nitroso or mitomycin; more than 4 weeks since last receiving radiotherapy, other cytotoxic drugs or surgery.
  • Subjects can swallow and have normal gastrointestinal function.
  • Female subjects should agree to take contraceptives during the study and within 6 months after the study (such as intrauterine device [IUD], contraceptive drugs or condoms); within 7 days before they enter the study, their serum or human chorionic gonadotropin should be negative, and must be in the non-lactation period.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patients have uncontrolled large pleural effusion and ascites.
  • Patients have received steroid for more than 50 days, or requiring for steroid therapy for a long time.
  • Requirement for the therapeutic drugs prolonging QT interval(such as anti-arrhythmia drugs), and can not interrupt them.
  • Patients with a history of symptomatic brain metastases.
  • Patients have received small molecule targeted drug therapy of inhibition of HER-2 or EGFR.
  • Patients have participated in other drug clinical research in the past 4 weeks.
Show all 12Show fewer
  • Pregnant or lactating women are excluded from this study.
  • Patients with a history of allergic reactions attributed to compounds of similar chemical composition to the agents used in the study are ineligible;
  • Patients with active infection ;
  • Patients with cardiac disease including Angina, any significant or need to be treated arrhythmia，Myocardial infarction, Heart failure, LVEF<45%, other heart diseases that are not suitable for participating in the study judged by investigator.
  • Patients with other concurrent severe and/or uncontrolled medical conditions （including hypertension, severe diabetes, thyroid disease, etc.) that could cause unacceptable safety risks or compromise compliance with study requirements are ineligible.
  • Patients with a history of mental disorders, including epilepsy or dementia are ineligible.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Cancer Institute and Hospital,Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Qing Li, cheryliqing@aliyun.com

    Qing Li

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib Study to Evaluate the Tolerability and Pharmacokinetics of Selatinib Ditosilate Tablets in Patients With Advanced Breast Cancer

Brief Description:

This study is designed to evaluate the safety and tolerability of oral Selatinib Ditosilate Tablets, and explore the maximum tolerated dose (MTD) and dose-limiting toxicity in patients with advanced breast cancer.

Read the detailed description
  1. To evaluate the safety and tolerability of oral Selatinib Ditosilate Tablets, and explore the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT).
  2. To determine the pharmacokinetic profile of single and multi oral Selatinib Ditosilate Tablets .
  3. To determine preliminary dose and regimen for phase II study of oral Selatinib Ditosilate Tablets.
  4. To assess preliminary antitumor activity .
Being tested
selatinib ditosilate tablets

What participants receive

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

  • selatinib ditosilate tabletsDrug

Study groups in NCT01931943
Study groupRoleWhat they receive
Selatinib Ditosilate TabletsExperimentalSelatinib Ditosilate either at 450,750,1000,1250mg, p.o. once daily
Receives: Drug: selatinib ditosilate tablets

What is being measured

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

  1. Dose-limiting toxicity(DLT)

    Measured: 21 days

  2. Maximum tolerated dose(MTD)

    Measured: 21 days

Secondary outcomes (2)

  1. Pharmacokinetics

    Selatinib Ditosilate pharmacokinetic parameters , include AUC, Cmax, Tmax, and t1/2

    Measured: 21 days

  2. Pharmacodynamics

    The response of Salatinib Ditosilate on tumor measured by CT or MRI.

    Measured: 7 weeks

Timeline

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

  1. First posted30 Aug 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2013 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01931943
Sponsor's protocol ID
QLSLTN-102
Status last verified
Aug 2013
First submitted
25 Aug 2013
Last updated
30 Aug 2013
Results posted
No

Publications

  • Zhang T, Li Q, Chen S, Luo Y, Fan Y, Xu B. Phase I study of QLNC120, a novel EGFR and HER2 kinase inhibitor, in pre-treated patients with HER2-overexpressing advanced breast cancer. Oncotarget. 2017 May 30;8(22):36750-36760. doi: 10.18632/oncotarget.13581.

    PubMed 27902470

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing selatinib ditosilate tablets in people with Advanced Breast Cancer, run by Qilu 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 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 30 Aug 2013. 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?

Dose-limiting toxicity(DLT) (time frame: 21 days). 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?

On the ClinicalTrials.gov record for NCT01931943, which also lists 1 linked publication.

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 30 Aug 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in