Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Breast Neoplasms

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Enzyme Inhibitors

Protein Kinase Inhibitors

Tubulin Modulators

Antimitotic Agents

Tirbanibulin

The phase I portion is a standard, three-patient per cohort, dose escalation schedule will be used. 3 or 6 subjects with solid tumor per dose group will likely be necessary to determine the MTD of KX2-391 in combination with weekly paclitaxel. With paclitaxel dose fixed at 80 mg/m2/weekly, KX2-391 treatment will be started at 20 mg dose once daily (QD)

The phase II portion of this trial has a design to determine the efficacy of KX2-391 when administered in combination with paclitaxel in 20 subjects with stomach cancer and 20 subjects with breast cancer

A treatment cycle in phase I will consist of 28 days, according to the following schedule:

KX2-391 20 mg PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.

The trial will initially test the combination of weekly paclitaxel and KX2-391 given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort, this intervention will be terminated

A treatment cycle in phase II will consist of 28 days, according to the following schedule:

KX2-391 MTD PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.

KX2-391 and Paclitaxel

Seock-Ah Im, M.D., Ph.D.

Jee Hyun Kim, M.D., Ph.D.

Yun Jin Kim

Eunkyung Kim

The primary objective of this study is to determine the maximum tolerated dose (MTD) of KX2-391 in Combination with paclitaxel in Phase I, and to evaluate the efficacy of KX2-391 in combination with paclitaxel in patients who are diagnosed as gastric and breast cancer, respectively in Phase II.

A Study of KX2-391 With Paclitaxel in Patients With Solid Tumors

An Open-label Phase I/II Study of KX2-391 in Combination With Paclitaxel in Patients With Advanced Solid Tumors

Pre-dose and post-dose tubulin inhibition in peripheral blood monocytes extracted from blood samples, as measured by immunofluorescence staining

Pre-dose and post-dose Src signaling inhibition (p-Src and Ki-67) in archival tumor tissue and new biopsy sample, as measured by immunohistochemistry

Maximum tolerated dose (MTD) of KX2-391 in combination with weekly paclitaxel as determined by number of participants With DLTs related to KX2-391 in combination with weekly paclitaxel

The efficacy (overall response rate; ORR; complete response (CR) + partial response (PR)) of KX2-391 in combination with weekly paclitaxel at the MTD established during the phase I portion of this trial based on Response Evaluation Criteria in Solid Tumor (RECIST) 1.1

PK parameters, including but not limited to, plasma concentration, AUC (Area Under Curve) 0-t, Cmax, Tmax, and T1/2 of KX2-391 alone and in combination with weekly paclitaxel

The preliminary efficacy of KX2-391 in combination with weekly paclitaxel as determined by ORRs based on RECIST 1.1

Adverse events and their frequency, duration and severity, physical examination, laboratory parameters, vital signs and ECG change monitoring as determined based on CTCAE (Common Toxicity Criteria for Adverse Effects) 4.03

Overall survival (OS), progression free survival (PFS), time to tumor progression (TTP) and duration of response

PK parameters, including but not limited to, plasma concentration, AUC0-t, Cmax, Tmax, and T1/2 of KX2-391 alone and in combination with weekly paclitaxel

Hanmi Pharmaceutical Company Limited

Symptoms and General Pathology

Neoplasm Metastasis

Skin Diseases

Breast Diseases

Neoplastic Processes

Capecitabine

Docetaxel

Antimetabolites

Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle.

Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle

Eligible patients will receive treatment with Capecibatine (1000 mg/ m2 twice daily D1-14 Q3W) plus docetaxel(75 mg/m2, D1,Q3W) for a maximum of 6 cycles, or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.

For the the patients with SD, PR or CR after initiate treatment phrase will enter into maintenance treatment phase.

Docetaxel plus Capecitabine

Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle

Intermittent Capecitabine

Metronomic Capecitabine

Binghe Xu, MD, PhD

Fei Ma, MD

It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast cancer(mBC).

Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC

A Randomized Phase III Study of Metronomic vs. Intermittent Capecitabine Maintenance Therapy Following First-line Capecitabine and Docetaxel Therapy in HER2-negative Metastatic Breast Cancer

Time from randomization to progression or death (whichever occurred first).

Adverse events (AEs) and laboratory tests graded according to the NCI CTCAE (version 4.0), premature withdrawals and vital signs. Hand-foot syndrome and diarrhea will be specially interested.

Adverse events of special interest: hand-foot syndrome and diarrhea. The estimated HFS rate will be about 60% from intermittent Capecitabine vs about 10% from metronomic Capecitabine, diarrhea rate will be about 50% from intermittent Capecitabine vs about 10% from metronomic Capecitabine.

Defined as CR+PR, assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase.

Defined as CR+PR+SD, assessed based on on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria. It will be evaluated in the initial treatment phase and the maintenance treatment phase

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of KX2-391 With Paclitaxel in Patients With Solid Tumors	NCT01764087	Unspecified Adu... Gastric Cancer Breast Cancer	KX2-391 and Pac...	20 Years -	Hanmi Pharmaceutical Company Limited
Capecitabine Maintenance Therapy Following Capecitabine Combined With Docetaxel in Treatment of mBC	NCT01917279	Breast Neoplasm... Neoplasms by Si... Neoplasm Metast... Breast Diseases Skin Diseases	Docetaxel plus ... Intermittent Ca... Metronomic Cape...	18 Years -	ChineseAMS

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