Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

Patients receive BPI-28592 PO. Cycles repeat every 28 days.

Characterize the pharmacokinetics (PK)，safety，antitumor activity of BPI-28592

BPI-28592

Hongming Pan, Ph.D

This is an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors

A Phase 1 Study of BPI-28592 in Subjects With Advanced Solid Tumors

A Phase 1，Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ascendind Doses of BPI-28592 in Subjects With Advanced Solid Tumors

Number of subjects with treatment related adverse events

Number of subjects with dose limiting toxicity

Evaluate clinical activity/efficacy of BPI-28592

Betta Pharmaceuticals Co., Ltd.

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Vinorelbine

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Simultaneous use of Vinorelbine and Capecitabine

Sequential use of Vinorelbine and Capecitabine

Vinorelbine 25mg/m2 D1, D8 q3w Capecitabine 1000mg/m2 D1-D14 q3w

Vinorelbine and Capecitabine

Vinorelbine 25mg/m2 D1, D8 q3w. When disease progression or untolerated toxicity occurs, Capecitabine 1000mg/m2 D1-D14 q3w

XiChun Hu, MD, PhD

The primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.

The administration of vinorelbine and capecitabine had been implied to be quite useful in metastatic breast cancer. This study was designed to explore whether sequential and simultaneous use of vinorelbine and capecitabine have similar efficacy and whether the sequential way has better tolerability.

Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)

Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer

PFS was assessed every two cycles (3 weeks per cycle)and during the follow up time, by serum tumor markers, physical examination and image examination, until disease progression event occurs. If a patient has the sign or hint of disease progression, then the lab examination, physical examination or image examination could be taken at any time.

Safety and QOL were assessed every cycle(3 weeks per cycle) and during the follow up time, until 28 days after the last cycle.

TTP and OS were assessed every cycle(3 weeks per cycle) and during the follow up time, until the event occurs.

Fudan University

Xichun Hu/Dr.

Gastrointestinal Agents

Docetaxel

Cisplatin

Esomeprazole

Proton Pump Inhibitors

Antacids

Anti-Ulcer Agents

Enzyme Inhibitors

docetaxel and cisplatin chemotherapy combined with PPI 160mg per day.

docetaxel and cisplatin chemotherapy combined with PPI 200mg per day.

Docetaxel and cisplatin chemotherapy combined with high dose PPI. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.PPI 200mg p.o. d1-3 every week for 66 weeks.

Arm C

Docetaxel and cisplatin chemotherapy combined with lower dose PPI. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.PPI 160mg p.o. d1-3 every week for 66 weeks.

Arm B

Docetaxel and cisplatin chemotherapy. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.

Arm A

XiChun Hu, MD,Ph. D

Antonio Chiesi

Stefano Fais, MD PHD

The objectives of this study are to evaluate the efficacy and tolerability of high dose proton pump inhibitor combined with chemotherapy in metastatic breast cancer.

High dose proton pump inhibitor (PPI) has been proved beneficial and it improved efficacy when combined with chemotherapy in preclinical and clinical trials.This study was designed to explore whether adding a proton pump inhibitor into docetaxel and cisplatin chemotherapy improves efficacy and does not affect tolerability in metastatic breast cancer.

Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer

Phase II Study of Docetaxel and Cisplatin Chemotherapy Versus Docetaxel and Cisplatin Chemotherapy Combined With High Dose Proton Pump Inhibitor in Metastatic Breast Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1 Study of BPI-28592 in Subjects With Advanced Solid Tumors	NCT05302843	Metastasis, Neo...	BPI-28592	18 Years -	Betta Pharmaceuticals Co., Ltd.
Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)	NCT00629148	Breast Cancer Metastasis, Neo...	Vinorelbine and... Vinorelbine and...	18 Years - 70 Years	Fudan University
A Phase 1 Study of BPI-28592 in Subjects With Advanced Solid Tumors	NCT05302843	Metastasis, Neo...	BPI-28592	18 Years -	Betta Pharmaceuticals Co., Ltd.
Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer	NCT01069081	Breast Cancer Metastasis, Neo...	Arm C Arm B Arm A	18 Years -	Fudan University
Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer	NCT01069081	Breast Cancer Metastasis, Neo...	Arm C Arm B Arm A	18 Years -	Fudan University

Spots Global Cancer Trial Database for metastasis, neoplasm