Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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.

Stage1:Dose esclation. Stage2:the expansion cohort where one or no DLT takes place in planned study cohort.

Proxalutamide

Ke Chen

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.

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period is needed after 7-day single dose administration, until disease progression, intolerable toxicities (AEs), or withdrawn consent.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.

Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer

Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer: an Open-label, Multi-center, Dose-escalating，Phase I/Ib Study.

Each dose cohort will initially include 3 evaluable patients for assessment of toxicity within the 35 days following the first dose of GT0918.

100 mg, 200 mg, 300 mg, 400 mg or 500 mg of GT0918

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.

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

Suzhou Kintor Pharmaceutical Inc,

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Prostatic Neoplasms

Hypersensitivity

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

Androgen Receptor Antagonists

Hormones

Hormone Antagonists

Androgen Antagonists

Group 1: Post enzalutamide failure

Group 2: Post abiraterone failure

GT0918

This was a multiple-center, open-label, randomized, daily dose, two-sequence, expanded/phase II study in subjects with mHSPC or mCRPC who progressed after either abiraterone or enzalutamide treatment.

The objective of the study is to evaluate the safety and tolerability of proxalutamide and determine the RP2D for Ph III and/or other confirming studies.

Subjects will be randomized into the 2 treatment arms.

This study is an open-label, randomized, expanded/phase II study in subjects with mHSPC or mCRPC who progressed after either abiraterone or enzalutamide. All subjects will be randomized to take 400 mg or 500 mg of GT0918 by oral administration once daily on an empty stomach (2-3 hours after a meal) for initial treatment of 6 months. Randomization of subjects will be stratified by prior therapy (abiraterone or enzalutamide).

Subjects will continue treatment with GT0918 (proxalutamide) at their assigned dose on an empty stomach until disease progression, intolerable toxicities (AEs), or withdrawn consent. A post-treatment period of 4 weeks will commence that concludes with an end-of-study visit.

Disease progression will be assessed by three methods over the duration of the study. Subjects will be assessed for biochemical (PSA) progression measured monthly, as well as radiographic progression by CT scan or/and bone progression by radionuclide bone scan every 12-weeks. Progressive disease will be considered on the occurrence of the first assessed progression event. Subjects with PSA progression only may continue the study until radiographic or bone progression at the discretion of the Investigator and with agreement by the sponsor or their authorized medical monitor.

The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC

An Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC Who Failed Either Abiraterone or Enzalutamide

To evaluate the safety and tolerability of GT0918 assessed by AEs, SAEs between 400 mg arm vs. 500 mg arm with mHSPC or mCRPC who failed either abiraterone or enzalutamide treatment The percetage of AE and SAE would be evaluated in subjects with mHSPC and to determine the recommended Phase II dose (RP2D) over 6 months or longer treatment

The percentage of subjects achieving a ≥50% reduction in PSA at 3 months (12 weeks) as compared to baseline (study entry) was determined.

Time to PSA Progression in 400mg group and 500mg group

The percentage of change of PSA from baseline at Week 12 was calculated. Maximum percentage change of PSA from baseline at any time was calculated.

An adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges or, if present at screening, worsens during the study, regardless of the suspected cause of the event.The period of collection of AEs is from the time of first dose to the last dose of study drug or EOS visit. The 30-day safety follow up "window" is set to capture possibly drug-related AE and/or SAE.

Group 1: Post enzalutamide failure

Group 2: Post abiraterone failure

GT0918: anti-tumor activity

Arm 1: 400 mg /Day of GT0918

Arm 2: 500 mg/Day of GT0918

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Millie Gu

TEAE

The Safety Analysis Set (SS) included all 61 subjects who have taken at least one dose of study medication;31 subjects and 30 subjects were incuded in 400mg daily arm and 500mg daily arm,respevtively

Evaluate the Safety and Tolerability of GT0918 and Select the RP2D for Future Clinical Trial Study.

PSA ≥50% reduction at Week 12

PSA ≥50% reduction at Week 24

The Full Analysis Set (FAS) will include subjects who have post-baseline PSA assessment.

The Percentage of Subjects Achieving a ≥50% Reduction in PSA at 12 Weeks and 24 Weeks

The Full Analysis Set (FAS) will include subjects who have at least one post-treatment tumor assessment.

Time to PSA Progression

GT0918 400mg Daily

GT0918 500mg Daily

The percentage change of PSA from baseline at any visit was calculated for the FAS

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer	NCT04103853	Metastatic Brea...	Proxalutamide	18 Years -	Suzhou Kintor Pharmaceutical Inc,
The Safety and Tolerability of GT0918 in Subjects With mHSPC and mCRPC	NCT03899467	Metastatic Cast... Metastatic Horm...	GT0918	18 Years -	Suzhou Kintor Pharmaceutical Inc,

Spots Global Cancer Trial Database for gt0918

Every month we try and update this database with for gt0918 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gt0918

Every month we try and update this database with for gt0918 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gt0918 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.