Gastrointestinal Stromal Tumors

Anlotinib 12mg.qd ,taken for 2 weeks and discontinued for 1 week, namely 3 weeks (21 days).

Anlotinib

Beijing Cancer Hospital

Efficacy and Safety of Anlotinib in Patients With Advanced Gastrointestinal Stromal Tumor After Failure of Imatinib: a Prospective, Single Arm and Multicenter Trial

Cttq

If no material of healthy volunteers of the SERT study can be used, then other matched volunteers are asked for a vena punction and urine collection

Patients are asked for a vena punction and urine collection, if not already done because of medical care.

Neuroendocrine Tumors

vena punction

University Medical Center Groningen

The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors

Exploring the Metabolic Profile of Neuroendocrine Tumors

A.M.E. Walenkamp

principal investigator

Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)

Patients going on the Pharmacodynamic study will receive JI-101 only.

Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.
Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus.

Pharmacokinetic Arm - Phase 1

Patients going on the Pharmacodynamic study will receive JI-101 only.
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.

Pharmacokinetic Arm-Phase II

Total

Sex: Female, Male

Determine the mean percent change that JI-101 has on the peak concentration as determined by calculating the AUC (0-inf) of RAD001 in the presence and absence of JI-101

Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)
JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.
Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1).

Pharmacokinetic Arm

Effect of JI 101 on Pharmacokinetics Area Under Curve (AUC) (0-inf) of RAD001

Determine the mean percent change that RAD001 has on the peak concentration as determined by calculating the AUC (0-inf) of JI101 in the presence and absence of RAD001

Pharmacokinetic Arm Phase 1

Effect of RAD001 on Pharmacokinetics AUC(0-inf) of JI-101

Number of patients experiencing a grade 2 or higher Adverse Event related to JI101

Safety and Tolerability of JI-101

Response Rate determined by the sum of patients achieving complete or partial response to JI-101 as defined by Response Evaluation Criteria in Solid Tumors. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Tumor Response

progression-free survival at 2 months. We define progression as using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), to detect a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Pharmacodynamic Arm Phase 2

Progression Free-Survival in the Ovarian Cancer Cohort

Response Rate determined by the sum of patients achieving complete or partial response to JI-101 as defined by Response Evaluation Criteria in Solid Tumors

Tumor Response in the Ovarian Cancer Cohort

Overall Study

Sunil Sharma, MD

Pharmacodynamic Arm

Cancer

Neuroendocrine

Ovarian Cancer

Colon Cancer

JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.

JI-101

Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1).

Everolimus

Huntsman Cancer Institute

Study of JI-101 in Patients With Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers

Drug- Drug Interaction Study of JI-101 & Everolimus in Advanced Solid Tumors, Expansion Pharmacodynamic Study of JI-101 in Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers

University of Utah

Jubilant Innovation Ltd.

Metastatic Malignancies

Side Effects of Vascular Endothelial Growth Factor (VEGF) and Epidermal Growth Factor Receptor (EGFR) Directed Therapy

Mabtornib Protocol.Vascular, Metabolic and Hormonal Effects of Angiogenesis Inhibitors and Epidermal Growth Factor Receptor Inhibitors

Vascular function tests at baseline, after 3 and after 6 weeks of treatment, blood and urine measurements as long as treatment is continued.

indol/xərçəng xəstəliyi

Efficacy and Safety of Anlotinib in Patients With Advanced Gastrointestinal Stromal Tumor After Failure of Imatinib: a Prospective, Single Arm and Multicenter Trial

The Indol Profile; Exploring the Metabolic Profile of Neuroendocrine Tumors

Study of JI-101 in Patients With Advanced Low Grade Endocrine Tumors, Ovarian Cancers or K-RAS Mutant Colon Cancers

Side Effects of Vascular Endothelial Growth Factor (VEGF) and Epidermal Growth Factor Receptor (EGFR) Directed Therapy

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