Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

CC-122 is administered orally, on a 5 continuous days out of 7 days per week intermittent dosing schedule.

5 continuous days out of 7 days per week intermittent dosing

CC-122

Bristol-Myers Squibb

To determine the safety and tolerability of CC-122 when administered orally to adult Japanese subjects with advanced solid tumors or Non-Hodgkin's Lymphoma (NHL) and to define the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

This is a phase 1, multicenter, open-label, dose-escalation study that will evaluate the safety, tolerability, (Pharmacokinetics) PK, and preliminary efficacy of CC-122 in Japanese subjects with advanced solid tumors or Non-Hodgkin's Lymphoma (NHL).

Subjects will receive ascending dose levels of CC-122 from Cycle 1 onwards to measure PK and to determine safety and tolerability.

An initial cohort of at least three subjects will be given CC-122 at a dose of 2.0 mg on an intermittent dosing schedule (5 continuous days out of 7 days per week) and 3-6 subjects will be enrolled in subsequent dose levels. Dose escalation for subsequent cohorts will proceed according to a standard dose escalation design (3+3 design) (Storer, 1989) to establish initial toxicity.

A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL)

A Phase 1, Multi-center, Open-label Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of CC-122 Administered Orally to Adult Japanese Subjects With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

The last dose level with 0 or 1 out of 6 subjects experiencing Dose Limiting Toxicities (DLTs) during the DLT evaluation period.

Number of participants with adverse events

Area under the plasma concentration time-curve

Time to maximum plasma concentration (Tmax).

Antitumor efficacy, determined by response rates in each tumor type using appropriate tumor response criteria, and duration of response

Celgene

TKI258

Novartis Pharmaceuticals

The purpose of in this study is to assess the safety profile and estimate the maximum tolerated dose of TKI258 in Japanese patients.

Phase I Dose Escalating Study of TKI258

A Phase I Dose Escalating Study to Evaluate TKI258 Administered Orally on a 5 Days on/2days Off Schedule in Japanese Patients With Advanced Solid Tumors

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Cafusertib (d1 and 15 - one hour iv.) + LD ARA C 2x20 mg/d s.c. Patient to receive escalating dose of cafusertib hydrochloride.

Drug: Cafusertib Hydrochloride (d1 and 15) Cafusertib (d1 and 15 - one hour iv.v) Drug: Cytarabine Cytarabine 2 x 20 mg/d s.c. d1-15.

Cafusertib Hydrochloride

Jianxiang Wang

To investigate safety, tolerability of cafusertib combination with low dose cytarabine (LD-Ara-C) in Chinese patients with relapsed/refractory AML that are not eligible for conventional or intensive treatment. The dose of cafusertib will be escalated to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cafusertib in combination with LD-Ara-C in AML patients. At the same time, pharmacokinetic characteristics and preliminary efficacy of cafusertib will be observed in AML patients. To determine the recommended dosage regimen for phase II.

Phase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)

An Open Phase I Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous Cafusertib Hydrochloride in Combination With Subcutaneous Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Micronutrients

Hematinics

Vitamins

Antibodies

Antibodies, Monoclonal

Gemcitabine

Paclitaxel

Carboplatin

Irinotecan

Leucovorin

Fluorouracil

Albumin-Bound Paclitaxel

Oxaliplatin

Immunoglobulins

Endothelial Growth Factors

Mitogens

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

hPV19 mAb plus FOLFOX(5-Fluorouracil,Oxaliplatin,Leucovorin)

hPV19 mAb plus FOLFIRI(5-Fluorouracil,Irinotecan, Leucovorin)

Intravenous (IV) infusions, 4 and 6 milligrams per kilogram (mg/kg) every 2 weeks

hPV19 mAb

Intravenous (IV) infusions, 6 milligrams per kilogram (mg/kg) every 3 weeks

400 mg/m2 bolus followed by a 2400 mg/m2 continuous infusion, every 2 weeks

5-Fluorouracil

IV Infusion, 85 milligrams per square meter (mg/m2) every 2 weeks

IV infusion, 1000 mg/m2 at day1 and day 8 every 3 weeks

IV Infusion,180 milligrams per square meter (mg/m2) every 2 weeks

Jin Li, MD,Phd

Jin Li, Professor

Ye Guo, Professor

hPV19 is a monoclonal antibody (mAb) directed against vascular endothelial growth factor (VEGF). hPV19 binds to human VEGF with unique binding site on VEGF different from that of Bevacizumab(Avastin) and inhibits the binding of VEGF to it's receptors, VEGF-R1 and VEGF-R2. By preventing VEGF binding to its receptors, growth of tumor blood vessels are inhibited and tumor growth prevented or slowed. In this study we are investigating the tolerability, safety, pharmacokinetics and anti-tumor activity of hPV19 in combination with chemotherapy in patients with solid tumors. hPV19 will give to patients by intravenous(i.v.) infusion with a single and multiple doses.

A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors

A Phase Ib Study of hPV19, a Novel Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF),in Combination With Chemotherapy in Patients With Advanced Solid Tumors Refractory to Standard Therapy.

DLTs were adverse events (AEs) possibly related to study drug that met the National Cancer Institute's Common Terminology Criteria for AEs (NCI CTCAE, version 4.03) with any one of the following:

1. Grade 4 neutropenia ≥7 days; febrile neutropenia; grade 4 anemia; grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding;
2. ≥ grade 3 nonhematologic toxicity with the exception of nausea, vomiting, diarrhea, dehydration or electrolyte abnormalities that resolved to a lower grade with maximum supportive treatment within 3 days;
3. ≥Grade 3 hypertension that cannot resolved to a lower grade with supportive treatment within 2 weeks or uncontrolled hypertension;
4. Urine protein ≥3.5 grams/24 hours and cannot resolved to \< 1.0 grams/24 hours within 2 weeks;
5. Gastrointestinal perforation: symptoms, signs and imaging evidence of abdominal pain require surgical treatment;
6. Grade 3 or 4 arterial thromboembolism, including stroke and myocardial infarction;

Data are presented for the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade ≥3 TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to hPV19. Events related to chemotherapy were reported separately.

t1/2 is the time required for the plasma/serum concentration to decrease 50%

Vss is the theoretical volume in which the total amount of study drug would need to be uniformly distributed during steady state to produce the same concentration as it is in plasma/serum

Best overall response evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria.

Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 mm (the appearance of 1 or more new lesions was considered progression). Stable Disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.

SuZhou Stainwei Biotech Inc.

Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation.

MEDI5752

This is a Phase 1, open-label study evaluate the safety, tolerability, pharmacokinetics, immunogenicity and anti-tumor activity of MEDI5752 in Japanese patients with advanced solid solid tumors.

\<Objectives\>

Primary Objective:

To evaluate the safety and tolerability of MEDI5752 in Japanese subjects with advanced solid tumors.

Secondary Objective:

To assess the anti-tumor activity and efficacy of MEDI5752. To describe the pharmacokinetics of MEDI5752.

Exploratory Objective:

To conduct exploratory research into factors that may be predictive of response or may influence the progression of cancer and/or response (efficacy) to MEDI5752.

Eligible patients will be administered as a single dose at each Cycle Day1. Each cycle from Cycle 1 has a duration of 21 days.

A minimum of 3 and a maximum of 9 evaluable patients will be enrolled in each cohort.

MEDI5752 in Japanese Patients With Advanced Solid Tumors.

A Phase 1, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Japanese Subjects With Advanced Solid Tumors

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

The primary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v5.0.

The primary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v5.0.

The primary endpoint is as assessed by the number of subjects experiencing dose limiting toxicities (DLTs) as defined by the protocol.

The primary endpoint is as assessed as the number of subjects experiencing changes in laboratory parameters from baseline.

The primary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.

The primary endpoint is as assessed by the the number of subjects experiencing clinically significant changes in ECG parameters from baseline.

The endpoints for assessment of antitumor activity is defined by using ORR, PFS, BOR,DCR, DoR and TTR according to RECIST v1.1.

The endpoints for the assessment of PK of MEDI5752 include individual MEDI5752 concentrations at different time points after administration. (e.g., Maximum plasma concentration\[Cmax\]）

The endpoints for the immunogenicity of MEDI5752 include the number of subjects who develop detectable anti-drug antibodies (ADAs)

The endpoint for the PD-L1 expression will be determined by Immunohistochemistry characterization.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL)	NCT02509039	Lymphoma, Non-H...	CC-122	20 Years -	Celgene
Phase I Dose Escalating Study of TKI258	NCT01471548	Advanced Solid ...	TKI258	20 Years -	Novartis
Phase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)	NCT02140606	Leukemia, Myelo...	Cafusertib Hydr...	18 Years -	Jiangsu Hansoh Pharmaceutical Co., Ltd.
A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors	NCT03503604	Solid Tumors	hPV19 mAb hPV19 mAb 5-Fluorouracil Oxaliplatin Leucovorin Paclitaxel Carboplatin Gemcitabine Carboplatin Irinotecan	18 Years - 75 Years	SuZhou Stainwei Biotech Inc.
A Study of CC-122 to Assess the Safety and Tolerability in Japanese Patients With Advanced Solid Tumors and Non-Hodgkin's Lymphoma (NHL)	NCT02509039	Lymphoma, Non-H...	CC-122	20 Years -	Celgene
Phase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)	NCT02140606	Leukemia, Myelo...	Cafusertib Hydr...	18 Years -	Jiangsu Hansoh Pharmaceutical Co., Ltd.
A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors	NCT03503604	Solid Tumors	hPV19 mAb hPV19 mAb 5-Fluorouracil Oxaliplatin Leucovorin Paclitaxel Carboplatin Gemcitabine Carboplatin Irinotecan	18 Years - 75 Years	SuZhou Stainwei Biotech Inc.
MEDI5752 in Japanese Patients With Advanced Solid Tumors.	NCT05685472	Advanced Solid ...	MEDI5752	18 Years - 120 Years	AstraZeneca
Phase I Dose Escalating Study of TKI258	NCT01471548	Advanced Solid ...	TKI258	20 Years -	Novartis

Spots Global Cancer Trial Database for phase1

Every month we try and update this database with for phase1 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 phase1

Every month we try and update this database with for phase1 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 phase1 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.