Metastatic Breast CancerPhase 1NCT04103853
Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer
A Phase 1 study testing Proxalutamide in people with Metastatic Breast Cancer, run by Suzhou Kintor Pharmaceutical Inc, at 7 sites in China.
Trial summary
This study is a multi-center, open-label, dose-esclation I/Ib clinical study to explore safety, efficacy an pharmacokinetics of proxalutamide in patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Proxalutamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 7 sitesChina
- Study dates
- 6 Sep 2017to 30 Jun 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years female;
- Stage 1:Histology or cytology confirmed metastatic breast cancer, first-line chemotherapy or targeted therapy failure or intolerance
- Stage 2: Histological or cytological confirmed metastatic breast cancer patients who failed or intolerant to anti-tumor therapy; have a positive AR test result;
- At least one measurable lesion based on RECIST version 1.1 ;
- ECOG performance status: 0-1;
- Have a predicted life expectancy of greater than 3 months;
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- The functions of the important organs are confirmed with the following requirement:
- Hemoglobin (HGB) ≥ 90 g/L(no blood transfusion within 14 days );
- Absolute neutrophil count (ANC) ≥ 1.5×10^9/L；
- Platelets (PLT) ≥ 100×10^9/L(If the coagulation function is normal,Platelets (PLT) ≥ 75×10^9/L )；
- Total bilirubin (TBIL) ≤ 1.5× Upper limit of normal value (ULN) -Aspartate aminotransferase (AST), alkaline phosphatase (ALP), and alanine -
- Aminotransferase (ALT) ≤2.5× ULN
- Understand and voluntarily sign the informed consent form；
- Subject is willing and able to comply with all protocol required visits and assessments；
Who cannot join
- Pregnant, lactating women, or those who have fertility and are reluctant to take effective contraceptive measures;
- Prior chemotherapy, radiation, targeted therapy ,androgen receptor inhibitors therapy (abiraterone,enzalutamide,etc )，other endocrine therapy ，and has acceptted traditional chinese herbal medicine treatment less than 4 weeks prior to the start of study medication.
- Has severe cardiovascular disease
- The toxicity of the previous treatment plan has not been restored before enrollment, and there is still non-hematologic toxicity of grade 1 or above (except for hair loss)
- Known gastrointestinal disease or condition that affects the absorption of GT0918;
- Known or suspected brain metastases, including the central nervous system and spinal cord compression or meningeal metastasis;
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- History of severe central nervous system diseases (including patients with epilepsy);
- Known hypersensitivity to proxalutmide or its excipients.
- Participated in clinical trials of other drugs or medical devices within one month prior to screening, or plan to participate in any other clinical trials during the study period;
- Subjects with any other serious disease considered by the investigator not in the condition to enter into the trial;
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Hunan Cancer Hospital
Changsha, Hunan
Sun-Yat-sen University Cancer center
Guangzhou, Fujian
Jiangsu Province Hospital
Nanjing, Jiangsu
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer: an Open-label, Multi-center, Dose-escalating，Phase I/Ib Study.
This study is a multi-center, open-label, dose-esclation I/Ib clinical study to explore safety, efficacy an pharmacokinetics of proxalutamide in patients with metastatic breast cancer.
This study includes two stages, stage I: single- and multiple-dose tolerance and pharmacokinetic study; stage 2: preliminary efficacy and safety study.
Read the detailed description
This study is a multi-center, open-label, dose-esclation study.
Subjects will be enrolled to the 100mg, 200mg, 300mg, 400mg and 500mg group in turn. Unless DLT was found, the dose esclation will continue. 28 days of DLT observation period is needed after 7-day single dose administration, until disease progression, intolerable toxicities (AEs), or withdrawn consent.
After the completion of stage 1, 2 doses for the stage 2 will be determined. In stage 2, patients with AR-positive metastatic breast cancer will be selected to explore the efficacy and safety of proxalutamide, and biomarkers will be explored.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Proxalutamide
- Keywords
- AR-positive metastatic breast cancer, Proxalutamide, metastatic breast cancer, GT0918
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProxalutamideDrug
Stage1:Dose esclation. Stage2:the expansion cohort where one or no DLT takes place in planned study cohort.
| Study group | Role | What they receive |
|---|---|---|
| Proxalutamide | Experimental | Stage one - Dose climbing:
Each dose cohort will assess toxicity within the 35 days following the first dose of GT0918.
Stage two- the expansion cohort :
30 patients will be enrolled to the 200mg cohort . 15 patients will be enrolled to the 300mg cohort. Receives: Drug: Proxalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity(DLT)
Each dose cohort will initially include 3 evaluable patients for assessment of toxicity within the 35 days following the first dose of GT0918.
Measured: 35 days
maximum tolerated dose (MTD)
100 mg, 200 mg, 300 mg, 400 mg or 500 mg of GT0918
Measured: 35 days
Disease Control Rate(DCR)
Preliminary evaluation of the DCR of GT0918 tablets in AR positive metastatic breast cancer patients, and determination of the recommended dose of proclamine in clinical trials.
Measured: 16 weeks
Secondary outcomes (7)
maximum concentration (Cmax)
Pharmacokinetics
Measured: 35 days
time that maximum concentration is observed (tmax)
Pharmacokinetics
Measured: 35 days
area under the concentration time-curve from time zero to infinity (AUC0∞)
Pharmacokinetics
Measured: 35 days
terminal elimination half life (t½)
Pharmacokinetics
Measured: 35 days
drug clearance (CL)
Pharmacokinetics
Measured: 35 days
apparent volume of distribution (Vd)
Pharmacokinetics
Measured: 35 days
Number of participants with treatment-related adverse events as assessed by CTCAE V4.03
200 mg, 300 mg of GT0918
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start6 Sep 2017
- Primary completion22 May 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute, Tianjin Medical University Cancer Institute and Hospital, Sun Yat-sen University, Ruijin Hospital, The First Affiliated Hospital with Nanjing Medical University, Hebei Medical University Fourth Hospital, Hunan Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- Ke Chen, Study director, Suzhou Kintor Pharmaceuticals,inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103853
- Sponsor's protocol ID
- GT0918-CN-2001
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2019
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jiang H, Ouyang Q, Yin Y, Tong Z, Shen K, Yuan Z, Geng C, Liu Y, Song G, Ran R, Li W, Qu Q, Wang M, Meng L, Tong Y, Li H. Proxalutamide in patients with AR-positive metastatic breast cancer: Results from an open-label multicentre phase Ib study and biomarker analysis. Eur J Cancer. 2022 Nov;176:1-12. doi: 10.1016/j.ejca.2022.08.025. Epub 2022 Sep 28.
PubMed 36182805Li H, Song G, Zhou Q, Ran R, Jiang H, Zhang R, Liu Y, Zhang J, Meng L, Ma L, Sun Y, Wang M, Zhou Q, Yan H, Zhou Q, Dong X, Tong Y. Activity of preclinical and phase I clinical trial of a novel androgen receptor antagonist GT0918 in metastatic breast cancer. Breast Cancer Res Treat. 2021 Oct;189(3):725-736. doi: 10.1007/s10549-021-06345-x. Epub 2021 Aug 14.
PubMed 34392453
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer: an Open-label, Multi-center, Dose-escalating，Phase I/Ib Study.
- ClinicalTrials.gov ID
- NCT04103853
- Acronym / sponsor ID
- GT0918-CN-2001
- Conditions
- Metastatic Breast Cancer
- Keywords
- AR-positive metastatic breast cancer, Proxalutamide, metastatic breast cancer, GT0918
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute, Tianjin Medical University Cancer Institute and Hospital, Sun Yat-sen University, Ruijin Hospital, The First Affiliated Hospital with Nanjing Medical University, Hebei Medical University Fourth Hospital, Hunan Cancer Hospital
- Study start
- 6 Sep 2017 (actual)
- Primary completion
- 22 May 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 26 Sep 2019 (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 study is a multi-center, open-label, dose-esclation I/Ib clinical study to explore safety, efficacy an pharmacokinetics of proxalutamide in patients with metastatic breast cancer.
This study includes two stages, stage I: single- and multiple-dose tolerance and pharmacokinetic study; stage 2: preliminary efficacy and safety study.
Detailed description
This study is a multi-center, open-label, dose-esclation study.
Subjects will be enrolled to the 100mg, 200mg, 300mg, 400mg and 500mg group in turn. Unless DLT was found, the dose esclation will continue. 28 days of DLT observation period is needed after 7-day single dose administration, until disease progression, intolerable toxicities (AEs), or withdrawn consent.
After the completion of stage 1, 2 doses for the stage 2 will be determined. In stage 2, patients with AR-positive metastatic breast cancer will be selected to explore the efficacy and safety of proxalutamide, and biomarkers will be explored.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proxalutamide | Experimental | Drug: ProxalutamideStage one - Dose climbing: Each dose cohort will assess toxicity within the 35 days following the first dose of GT0918. Stage two- the expansion cohort : 30 patients will be enrolled to the 200mg cohort . 15 patients will be enrolled to the 300mg cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years female;
- Stage 1:Histology or cytology confirmed metastatic breast cancer, first-line chemotherapy or targeted therapy failure or intolerance
- Stage 2: Histological or cytological confirmed metastatic breast cancer patients who failed or intolerant to anti-tumor therapy; have a positive AR test result;
- At least one measurable lesion based on RECIST version 1.1 ;
- ECOG performance status: 0-1;
Key exclusion criteria (10 listed)
- Pregnant, lactating women, or those who have fertility and are reluctant to take effective contraceptive measures;
- Prior chemotherapy, radiation, targeted therapy ,androgen receptor inhibitors therapy (abiraterone,enzalutamide,etc )，other endocrine therapy ，and has acceptted traditional chinese herbal medicine treatment less than 4 weeks prior to the start of study medication.
- Has severe cardiovascular disease
- The toxicity of the previous treatment plan has not been restored before enrollment, and there is still non-hematologic toxicity of grade 1 or above (except for hair loss)
- Known gastrointestinal disease or condition that affects the absorption of GT0918;
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 |
|---|---|---|
| ProxalutamideStage1:Dose esclation. Stage2:the expansion cohort where one or no DLT takes place in planned study cohort. | Drug | Proxalutamide |
Primary outcome
Dose-limiting Toxicity(DLT)
Time frame: 35 days
Each dose cohort will initially include 3 evaluable patients for assessment of toxicity within the 35 days following the first dose of GT0918.
maximum tolerated dose (MTD)
Time frame: 35 days
100 mg, 200 mg, 300 mg, 400 mg or 500 mg of GT0918
Disease Control Rate(DCR)
Time frame: 16 weeks
Preliminary evaluation of the DCR of GT0918 tablets in AR positive metastatic breast cancer patients, and determination of the recommended dose of proclamine in clinical trials.
7 secondary outcomes
maximum concentration (Cmax)
Time frame: 35 days
time that maximum concentration is observed (tmax)
Time frame: 35 days
area under the concentration time-curve from time zero to infinity (AUC0∞)
Time frame: 35 days
terminal elimination half life (t½)
Time frame: 35 days
drug clearance (CL)
Time frame: 35 days
apparent volume of distribution (Vd)
Time frame: 35 days
Number of participants with treatment-related adverse events as assessed by CTCAE V4.03
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Derived from this study: PubMed 36182805Jiang H, Ouyang Q, Yin Y, Tong Z, Shen K, Yuan Z, Geng C, Liu Y, Song G, Ran R, Li W, Qu Q, Wang M, Meng L, Tong Y, Li H. Proxalutamide in patients with AR-positive metastatic breast cancer: Results from an open-label multicentre phase Ib study and biomarker analysis. Eur J Cancer. 2022 Nov;176:1-12. doi: 10.1016/j.ejca.2022.08.025. Epub 2022 Sep 28.
- Derived from this study: PubMed 34392453Li H, Song G, Zhou Q, Ran R, Jiang H, Zhang R, Liu Y, Zhang J, Meng L, Ma L, Sun Y, Wang M, Zhou Q, Yan H, Zhou Q, Dong X, Tong Y. Activity of preclinical and phase I clinical trial of a novel androgen receptor antagonist GT0918 in metastatic breast cancer. Breast Cancer Res Treat. 2021 Oct;189(3):725-736. doi: 10.1007/s10549-021-06345-x. Epub 2021 Aug 14.
- 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.
Ke Chen study director
Suzhou Kintor Pharmaceuticals,inc
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Proxalutamide in people with Metastatic Breast Cancer, run by Suzhou Kintor Pharmaceutical Inc, at 7 sites 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 14 inclusion and 10 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: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting Toxicity(DLT) (time frame: 35 days). The study lists 3 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 NCT04103853, which also lists 2 linked publications.
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 24 Sep 2021.