Patient who diagnostic of Breast cancer, Colorectal cancer, cancer of Ovary, and cancer of Endometrial are can recruit.

Breast Cancer

Colorectal Cancer

Cancer of Ovary

Cancer of Endometrium

Diagnosis and acceptance of breast cancer, colon rectal cancer, ovarian cancer, and endometrial cancer by the clinical Western medicine team.

Cases for patients diagnosed with breast cancer, colonrectal cancer, ovarian cancer and endometrial cancer

China Medical University Hospital

Immunoassay and Regulation of Traditional Chinese Medicine on Cancer Patients

The cytokines expression of immune cells in the blood by traditional Chinese medicine treatment in breast cancer, colon-rectal cancer, ovarian cancer, and endometrial cancer will be investigated.

Dose Level -1: 25% decrease from prior dose level
- 0.40 mg/m2 administered intravenously on days 1-5, 8-12, and 15-19 of a 28 day cycle

Starting Dose Level 1:
0.53 mg/m2 administered intravenously on days 1-5, 8-12, and 15-19 of a 28 day cycle

Dose Level 2: 25% increase from Dose Level 1
- 0.67 mg/m2 administered intravenously on days 1-5, 8-12, and 15-19 of a 28 day cycle

Dose Level 3: 25% increase from Dose Level 2
- 0.80 mg/m2 administered intravenously on days 1-5, 8-12, and 15-19 of a 28 day cycle

Acute Myeloid Leukemia

Minnelide therapy may be administered for up to 12 cycles of 28 days are planned. If patients are receiving clinical benefit, treatment can continue beyond 12 cycles.

Minnelide

Minnelide in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia

A Phase I Pilot Study of Minnelide, A Novel Heat Shock Protein 70 Inhibitor, in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia

Rate of toxicity in study participants including serious adverse events (SAEs), grade 3 or higher adverse events (AEs), and dose limiting toxicities (DLTs) by treatment dose level cohorts. Toxicity will be assessed in terms of nature, grade and attribution to treatment, using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.03.
Evaluable for Safety: Study participants who receive at least one dose of Minnelide therapy.
Evaluable for DLT: Study participants who either experience a DLT during Cycle 1 or receive at least 12 (80%) of scheduled doses of minnelide during Cycle 1 without a DLT. Missed doses will not be made up. Eligible patients who discontinue minnelide therapy, miss more than 3 doses of Minnelide, or require a dose reduction in minnelide during Cycle 1 for reasons other than DLT will not be evaluable for DLT and will be replaced.

The MTD will be defined as highest dose level below or at the maximally administered dose for which ≤ 1 out of 6 patients experiences a dose-limiting toxicity (DLT). To determine the MTD of Minnelide, an approach using traditional "3+3" escalation rules will be used. Dose-limiting toxicity (DLT) will be defined as events that are considered by the investigator to be related to therapy with minnelide. Although DLTs may occur at any point during treatment, only DLTs occurring during Cycle 1 of treatment will influence decisions regarding dose escalation.

Following the proposed dose escalation and expansion cohort, the RP2D of Minnelide will be established as the highest dose level tested for which no more than 2 out of 12 patients experiences a dose-limiting toxicity.

Efficacy will be determined by overall response rate (ORR) to Minnelide therapy in study participants. Overall response rate includes rate of study participants experiencing complete response (CR), CR with incomplete bone marrow recovery (CRi); or Partial response (PR) to Minnelide therapy. Best response will be determined using serial blood and bone marrow sampling throughout the course of treatment. Responses will be documented according to revised/modified International Working Group (IWG) Response Criteria (Cheson et al. 2003 for AML and update 2010). Study participants who receive at least 1 cycle of protocol therapy, have measurable disease at baseline, and have at least one post-baseline disease assessment are evaluable for efficacy.

The area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC24hr) will be assessed. Serial blood samples for the determination of plasma concentrations of Minnelide will be collected at pre-specified time points during Cycle 1 to characterize the PK of Minnelide. Plasma for measuring Minnelide concentrations will be collected on day 1 and 8 pre-dose, at the end of infusion (EOI), 0.5, 2, 4, 6, 24 hours post-dose. Descriptive statistics will be used to summarize Cmax for each dose level and all patients. Study participants who receive at least 1 dose of minnelide therapy and undergo at least 5 PK blood draws with concentration-time data to reliably estimate PK parameters are evaluable for PK.

Cmax is the maximum (or peak) plasma concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose. Serial blood samples for the determination of plasma concentrations of Minnelide will be collected at pre-specified time points during Cycle 1 to characterize the PK of Minnelide. Plasma for measuring Minnelide concentrations will be collected on day 1 and 8 pre-dose, at the end of infusion (EOI), 0.5, 2, 4, 6, 24 hours post-dose. Descriptive statistics will be used to summarize Cmax for each dose level and all patients. Study participants who receive at least 1 dose of minnelide therapy and undergo at least 5 PK blood draws with concentration-time data to reliably estimate PK parameters are evaluable for PK.

Tmax is the time it takes a drug or other substance to reach the maximum concentration (Cmax). Serial blood samples for the determination of plasma concentrations of Minnelide will be collected at pre-specified time points during Cycle 1 to characterize the PK of Minnelide. Plasma for measuring Minnelide concentrations will be collected on day 1 and 8 pre-dose, at the end of infusion (EOI), 0.5, 2, 4, 6, 24 hours post-dose. Descriptive statistics will be used to summarize Tmax for each dose level and all patients. Study participants who receive at least 1 dose of minnelide therapy and undergo at least 5 PK blood draws with concentration-time data to reliably estimate PK parameters are evaluable for PK.

Terminal phase half-life (t1/2) will be assessed. Half-life (t1/2) is the amount of time it takes for the drug concentration in the plasma to decline by half. Serial blood samples for the determination of plasma concentrations of Minnelide will be collected at pre-specified time points during Cycle 1 to characterize the PK of Minnelide. Plasma for measuring Minnelide concentrations will be collected on day 1 and 8 pre-dose, at the end of infusion (EOI), 0.5, 2, 4, 6, 24 hours post-dose. Descriptive statistics will be used to summarize terminal phase half life for each dose level and all patients. Study participants who receive at least 1 dose of minnelide therapy and undergo at least 5 PK blood draws with concentration-time data to reliably estimate PK parameters are evaluable for PK.

Apparent total clearance of the drug from plasma, the rate at which a drug is removed from the body, considered as a single unit, the sum of renal clearance + hepatic clearance + other clearance, expressed as volume per unit time. Serial blood samples for the determination of plasma concentrations of Minnelide will be collected at pre-specified time points during Cycle 1 to characterize the PK of Minnelide. Plasma for measuring Minnelide concentrations will be collected on day 1 and 8 pre-dose, at the end of infusion (EOI), 0.5, 2, 4, 6, 24 hours post-dose. Descriptive statistics will be used to summarize terminal phase half life for each dose level and all patients. Study participants who receive at least 1 dose of minnelide therapy and undergo at least 5 PK blood draws with concentration-time data to reliably estimate PK parameters are evaluable for PK.

The apparent volume of distribution is the theoretical volume of fluid into which the total drug administered would have to be diluted to produce the concentration in plasma. Serial blood samples for the determination of plasma concentrations of Minnelide will be collected at pre-specified time points during Cycle 1 to characterize the PK of Minnelide. Plasma for measuring Minnelide concentrations will be collected on day 1 and 8 pre-dose, at the end of infusion (EOI), 0.5, 2, 4, 6, 24 hours post-dose. Descriptive statistics will be used to summarize terminal phase half life for each dose level and all patients. Study participants who receive at least 1 dose of minnelide therapy and undergo at least 5 PK blood draws with concentration-time data to reliably estimate PK parameters are evaluable for PK.

Pharmacodynamic (PD) measurements will be obtained from serial blood and bone marrow sampling at specified time points to describe the PD effects of Minnelide. PD paramaters include HSP70 expression and activity, mitochondrial cytochrome c, caspase-3 activation, PI3K/Akt/mTOR and MAPK/ERK pathway activity, and other relevant markers. Study participants who receive at least 1 dose of Minnelide and undergo at least 2 PD blood and bone marrow samples are evaluable. Descriptive statistics will be used to summarize PD parameters for each dose level and all patients.
Blood - PD Sampling at pre-dose Cycle 1 Day 1, Day 2 and Day 8; at investigator discretion afterwards on Day 1 of each/every other cycle , and End of Study visit; assessed up to 12 months
Marrow - PD Sampling at pre-dose Cycle 1 Day 1, Cycle 2 Day 1; at investigator discretion afterwards and End of Study visit; assessed up to 12 months

Justin Watts

Assistant Professor of Medicine

Minneamrita Therapeutics LLC

0.67 mg/m2 Minnelide daily as a 30min iv infusion on days 1-21 of each 28 day cycle, followed by a 7 day rest period (D 22-28).

Pancreatic Cancer

Minnelide will be administered at the dose of 0.67 mg/m2 as a 30 min infusion intravenously daily on days 1-21 of each cycle followed by a 7 day rest period (days 22-28).

HonorHealth Research Institute

Moores UC San Diego Cancer Center

University of Pennsylvania

A Phase II, International Open Label Trial of Minnelide™ in Patients With Refractory Pancreatic Cancer

MinPAC: A Phase II, International Open Label Trial of Minnelide™ in Patients With Refractory Pancreatic Cancer.

Time from enrolment until disease progression or death from any cause, whichever occurs first (RECIST v1.1)

Percentage of individuals on study attaining a CR + PR (RECIST v1.1)

Change in the sum of diameters of the target lesions

Percentage of patients with >20% decrease

Changes in circulating tumour stem cells.

Barts & The London NHS Trust

Translational Genomics Research Institute

Stand Up To Cancer

Cancer Research UK

Lustgarten Foundation

Queen Mary University of London

Participants will receive TwHF (20mg each time, 3 times per day, for 48 weeks) from Day 0 through the Week 48 study visit.

Participants will receive placebo treatment (20mg each time, three times per day for 48 weeks) from Day 0 through the Week 48 study visit.

Human Immunodeficiency Virus

Taken oral, three times per day, at a dose of 20 mg/time for 48 weeks.

triptolide/càncer

Immunoassay and Regulation of Traditional Chinese Medicine on Cancer Patients

Minnelide in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia

A Phase II, International Open Label Trial of Minnelide™ in Patients With Refractory Pancreatic Cancer

Tripterygium Wilfordii Hook F (TwHF) Treatment for Immune Non-responders With HIV-1 Infection

La base de dades d’herbes medicinals més completa avalada per la ciència