Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Oxaliplatin

Antimetabolites

Patients recruited will be treated by concurrent chemoradiotherapy with IGRT and two cytotoxic agents: capecitabine and oxaliplatin. Capecitabine will be taken orally twice a day, from D1 to D14 while oxaliplatin will be given intravenously on D1 and D8, every 21 days. The doses of the two drugs will be escalated alternatively in each level group. The radiation will be given by IGRT and the dose is between 45 to 54Gy, 1.8-3Gy per fraction.

IGRT

Capecitabine: by oral, D1-14, every 21 days, 600mg/m2 bid per day in level 1, and then escalated every another dose level.

Oxaliplatin: intravenously, D1 and D8, every 21 days, 30mg/m2 per day in level 1, and then escalated every another dose level.

Jing Jin, doctor

Hao Jing, doctor

This is a phase I study to evaluate the safety of concurrent chemoradiation combining radiotherapy (IGRT) with two cytotoxic agents, capecitabine and oxaliplatin in patients with advanced or inoperable hepatocellular carcinoma.

In this phase I study, patients with advanced or inoperable hepatocellular carcinoma, or those failed other strategies will be recruited. The primary tumor and nearby metastatic nodes will be irradiated with Image-Guided Radiation Therapy (IGRT) mostly with conventional fractions. During the course, oral capecitabine and intravenous oxaliplatin will be given concurrently. The maximum tolerated dose (MTD) for the two drugs will be determined during escalation according to the occurrence of dose limiting toxicities (DLT).

Phase I Study of Image-Guided Radiation Concurrent With Double-Agent Chemotherapy for Hepatocellular Carcinoma

Image-Guided Radiation Therapy (IGRT) Associated With Concurrent Capecitabine and Oxaliplatin in the Treatment of Locally Advanced or Inoperable Hepatocellular Carcinoma (HCC): A Phase I Study

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Sanofi

Chinese Academy of Medical Sciences

Vice Chair of Department of Radiation Oncology, Cancer Hospital

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Rare Diseases

Neuroendocrine Tumors

Mesothelioma

Mesothelioma, Malignant

Thymoma

Thymus Neoplasms

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adenoma

Neoplasms, Mesothelial

Thoracic Neoplasms

Lymphatic Diseases

Neuroendocrine Tumor

Malignant Mesothelioma

Neuroepithelioma

Olaparib

Somatostatin

Lutetium Lu 177 dotatate

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Radiopharmaceuticals

177Lu-DOTA-TATE in four cycles in combination with escalated doses of olaparib

177Lu-DOTA-TATE + olaparib

This is a phase I study of 177Lu-DOTA-TATE in combination with the PARP-inhibitor olaparib for treatment of patients with somatostatin receptor positive tumours detected by 68Ga-DOTA-TATE/TOC PET. The combination of a PARP inhibitor that will specifically target the repair mechanism, with ionising radiation causing SSB's might overcome the repair dependent survival of the tumour cells, making them more sensitive to β-emission and increase the probability of tumour cell death.

177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours

Phase I Trial With 177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours

To assess the number of participants with toxicity of 177Lu-DOTA-TATE in combination with olaparib measured by NCI Common Toxicity Criteria v 5.0

Response rate (RECIST) at 3 and 12 months

Advanced Accelerator Applications

Vastra Gotaland Region

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

Immunologic Factors

ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intratumoral injection every second week for 8 weeks. Patients that do not progress will be offered continued treatment until complete response, confirmed progressive disease, or clinical deterioration.

ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intravenous infusion every second week until complete response, confirmed progressive disease, or clinical deterioration.

Agonistic human monoclonal IgG1 anti-CD40 antibody

ADC-1013

Per Norlén, MD, PhD

Dorte Nielsen, MD, PhD

The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated injections directly into the tumor tissue) or intravenously (as repeated doses directly into a vein) in patients with advanced solid tumors.

ADC-1013 First-in-Human Study

A First-in-human, Multicenter, Open-label, Multiple Ascending Dose Phase I Study in Patients With Advanced Solid Tumors to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intratumorally or Intravenously Administered ADC-1013

Dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended Phase 2 dose of ADC-1013 administered intratumorally or intravenously will be defined.

Alligator Bioscience AB

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Breast Neoplasms

Colorectal Neoplasms

Prostatic Neoplasms

Lung Neoplasms

Ovarian Neoplasms

Pancreatic Neoplasms

Kidney Neoplasms

Breast Diseases

Skin Diseases

Respiratory Tract Neoplasms

Lung Diseases

Respiratory Tract Diseases

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Urologic Neoplasms

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Ovarian Cancer

Pancreatic Cancer

Starting dose of TAK-165 10 mg, tablets, orally, once daily with dose escalation to tolerability for 56 days.

TAK-165

Medical Director

The purpose of this study is to investigate a safe dose of TAK-165, once daily (QD), in patients with HER2-tumor expression.

The human epidermal growth factor receptor 2 (HER2) is a member of the Type 1 family of growth factor tyrosine kinases. HER2 forms hetero- and homo-dimers with other members of this family of tyrosine kinases. As a result of dimerization at the cell surface, intracellular signal transduction is initiated, resulting in cell proliferation.

HER2 expression has been observed in a variety of human tumors including breast cancer, non-small cell lung cancer, prostate cancer, pancreatic cancer, renal cell cancer, and ovarian cancer. HER2 overexpression is associated with clinically more aggressive breast cancer, and is an independent predictor of poor prognosis in patients with breast cancer.

TAK-165 is an active and selective inhibitor of tyrosine kinase activity of HER2 being developed for patients with lower levels of HER2 expression. This study will seek to determine the safety, tolerability, maximum tolerated dose and pharmacokinetics of TAK-165 administered to subjects with tumors known to express HER2.

The total duration of the study will be at minimum 8 weeks, or 56 Days. Subjects without progressive disease after 8 weeks may continue to receive study drug, provided that they do not meet criteria for withdrawal.

Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2

A Phase I, Open-Label, Dose Escalating, Multiple Dose Study to Determine the Safety, Tolerability, Maximum Tolerated Dose and Pharmacokinetics of Oral TAK-165 Administered Once Daily to Subjects With Tumors Known to Express HER2.

Takeda

Symptoms and General Pathology

Recurrence

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

intravenous ipilimumab following by intravenous SHR-1210

Patients received two doses of intravenous ipilimumab (at a dose of 1 mg per kilogram of body weight) every 3 weeks, following by intravenous SHR-1210 (at a fixed dose of 200mg) every 2 weeks.

SHR-1210

Wenfeng Fang, MD

Li Zhang, Master

Li Zhang, MD

Immunotherapy has made rapid progress in melanoma, Hodgkin's lymphoma, non-small cell lung cancer, and bladder cancer, etc. Preclinical data suggested that the use of anti-PD-1 antibody in combination with CTLA-4 receptor blockers may increase antitumor activity. The CheckMate-012 study showed that nivolumab and ipilimumab combination therapy achieved an overall response rate of 43% in unselected patients with non-small cell lung cancer, compared with 23% in the nivolumab monotherapy group; and in the PD-L1 positive subgroup, nivolumab in combination with ipilimumab showed a response rate of 57%, while nivolumab alone was 28%. This showed that the combination therapy of nivolumab and ipilimumab can increase the efficacy, but the adverse events of grade 3 or above of combination therapy reach 37%. The toxic side effects limit the widespread use of nivolumab in combination with ipilimumab therapy.

However, since the action of ipilimumab is limited to the initiation of the immune response (antigen presentation and immune cell activation), and its long half-time of 15.4 days, ipilimumab can used as an induction therapy, following by the PD1 monoclonal antibody. This phase I study is aimed to evaluated the safety and efficacy of CTLA-4 antibody followed by PD-1 antibody in patients with recurrent or metastatic non-small cell lung cancer.

Anti-CTLA-4 Antibody Followed by Anti-PD-1 Antibody in Recurrent or Metastatic NSCLC

A Phase I Study Evaluating the Safety and Efficacy of CTLA-4 Antibody Ipilimumab Followed by PD-1 Antibody SHR-1210 in Patients With Recurrent or Metastatic Non-small Cell Lung Cancer

Adverse events occurring up to 30 days after the last dose of ipilimumab or SHR1210 are evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.

ORR as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

CBR as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

OS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

DOR as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

TTP as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

Sun Yat-sen University

Director of Department of Medical Oncology, Professor

Endometrial Neoplasms

Uterine Neoplasms

Uterine Diseases

Anti-Infective Agents

Hormones

Sirolimus

Anastrozole

Aromatase Inhibitors

Temsirolimus

MTOR Inhibitors

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Following inclusion, patients will be randomized (2:1) to receive Arm A : AZD2014 + anastrozole Arm B : anastrozole alone

Mode of Action Selective and specific mTOR kinase inhibitor targeting both mTORC1 and mTORC2 complexes.

Route of Administration Oral

Dosage regimen 125mg BID with intermittent schedule (2 days of treatment followed by 5 days off (500mg/week))

Duration of treatment Until the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued per patient or investigator request.

AZD2014

Therapeutic Class Aromatase inhibitor

Mode of Action Potent and highly selective non-steroidal aromatase inhibitor.

Route of Administration Oral

Dosage regimen

1 mg tablet once a day

Duration of treatment Patients may continue treatment with anastrozole until the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued per patient or investigator request.

Pierre-Etienne HEUDEL, MD

The investigators hypothesize that the dual inhibition of mTORC1/mTORC2 by AZD2014 combined with inhibition of aromatase enzyme by anastrozole will act synergistically and may be an interesting therapeutic option for endometrial cancer with a manageable toxicity profile.

The investigators proposal is to conduct a multicenter, 2-step, randomized, Phase I/II trial to evaluate the safety and efficacy of a combination treatment associating anastrozole to AZD2014 in advanced endometrial cancer patients.

The study is divided in 2 steps :

* A safety run-in phase aiming to evaluate the safety of the proposed combination AZD2014 + anastrozole (Arm A) versus anastrozole alone (Arm B). No dose escalation is scheduled (doses are based on maximum tolerated dose (MTD) defined for AZD2014 and the summary of product characteristics (SPC) of anastrozole). However, dose de-escalation for AZD2014 will be applied in case of toxicity.
* A two-stage randomized Phase II part aiming to evaluate the clinical benefit of the AZD2014 + anastrozole (Arm A) combination therapy versus anastrozole (Arm B).

TREATMENT PLAN :

Following randomisation patients will receive Arm A : AZD2014 plus anastrozole or Arm B: anastrozole alone AZD2014 will be administered with an intermittent schedule i.e. 125 mg bis in die (BID) intermittent with 2 days on followed by 5 days off per week for a total weekly dose of 500 mg/week (250mg D1 and D2, 5 days off) Anastrozole will be administered at the standard dose defined in the SPC i.e. 1mg/d, per os, continuously.

Both treatment will be administered until progressive disease (PD), unacceptable toxicity or willingness to stop.

STATISTICS :

A total of 72 patients will be randomized in the study.

Safety run-in Phase on the first 9 patients randomized - As no dose escalation will be performed, the safety will be evaluated following the treatment and 8-week follow-up of the first 6 patients by the experimental association AZD2014+anastrozole (experimental arm). By similarity to a classic 3+3 design, based on binomial probabilities, there is a 90% probability of observing one or more patients with a toxicity event, if that event occurs in at least 32% of the target population. Assuming a 2:1 randomization ratio, a total of 9 patients (Arm A - Experimental: 6 patients, Arm B - Control: 3 patients) will be enrolled in this safety run-in phase and will be included in the evaluation of Phase II part.

Phase II The sample size calculation was based on a Simon optimal two-stage design, with a minimum success (8-week non progression) rate considered of interest p1=60% and an uninteresting rate p0=40%. Assuming a type I error alpha of 0.05 and 80% power, 46 evaluable patients are needed in the experimental arm to reject the null hypothesis H0: p≤p0 versus the alternative hypothesis H1: p ≥ p1 in a unilateral situation (16 patients in Stage I and 30 additional patients in Stage II).

With a 2:1 randomization and based on the assumption that 5% of the patients may be non-evaluable, a total of 72 patients will be included in the study : 48 patients in Arm A - experimental and 24 patients in Arm B - control).

DATA ENTRY, DATA MANAGEMENT AND STUDY MONITORING All the data concerning the patients will be recorded in the electronic case report form (eCRF) throughout the study. serious adverse event (SAE) reporting will be also paper-based by e-mail and/or Fax.

The sponsor will perform the study monitoring and will help the investigators to conduct the study in compliance with the clinical trial protocol, Good Clinical Practices (GCP) and local law requirements.

Hormone Receptor Positive endometrIal Carcinoma Treated by Dual mTORC1/mTORC2 Inhibitor and Anastrozole (VICTORIA)

A Multicentric, Randomized, Non Comparative, Open-label Phase I/II Evaluating AZD2014 (Dual Mammalian Target of Rapamycin Complex 1/2 (mTORC1/mTORC2) Inhibitor) in Combination With Anastrozole Versus Anastrozole Alone in the Treatment of Metastatic Hormone Receptor-positive Endometrial Adenocarcinoma

Severe toxicities defined as

* Any grade ≥ 4 treatment related toxicity
* Any grade≥ 3 treatment related toxicity lasting more than 7 days

Centre Leon Berard

Neoplasm Metastasis

Neoplastic Processes

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All enrolled patients received one treatment cycle of DKC cell therapy, which consists of 5 infusion cycles approximately 23 days apart. There were 3 dose levels: 5 x 10\^6, 1 x 10\^7, and 5 x 10\^7 cells, and the protocol followed a traditional 3+3 dose escalation design.

DKC is a hybrid cell type capable of dual functionality, i.e. cytotoxicity and antigen presentation, similar to NK cells and DCs, respectively.

Dendritic Killer Cell (DKC)

Yee Chou, M.D., Ph.D.

The primary objective of this study is to evaluate the safety of autologous dendritic killer cell (DKC) in patients with metastatic solid tumor and to evaluate the maximum tolerated dose (MTD) of DKC. The primary endpoint of safety evaluation includes physical examination, assessment of vital sign, laboratory test, concomitant medication, and adverse event (AE). The secondary endpoints regarding efficacy includes the generation of tumor specific immune response by detecting CD3+ CD8+ CD69+ IFN-gamma+ T cells, and the improvement of quality of life

Dendritic Killer Cell-based Immunotherapy for Solid Tumors

Phase I Clinical Trial of Autologous Dendritic Killer Cell-based Immunotherapy for Solid Tumors

The coding system used for AE is MedDRA. Only treatment-emergent adverse events (TEAEs) are considered for primary endpoint. Frequency table of subjects with pre-treatment and treatment-emergent AE are presented by each cohort and overall trial. AE incidents are summarized descriptively by system organ class and preferred term using MedDRA for each cohort and overall trial.

Serious adverse event incidence is summarized descriptively by system organ class and preferred term for each cohort and overall trial. The causality of SAEs will be assessed by the principal investigator for its relationship to study medication.

DLT is defined as Grade ≧ 3 (according to NCI-CTCAE 4.03 grading system), study medication-related (i.e. with causality determined as at least possibly related to study medication), and worsened in comparison to baseline (pre-treatment condition). DLT is determined after first infusion cycle and maximum tolerated dose (MTD) is determined as the highest dose without DLT. DLT is defined by the items listed below:

Blood and lymphatic system disorders: Grade ≧ 3 of (1) Any febrile neutropenia, (2) Leukocytosis, (3) Anemia

Other disorders: Grade ≧ 3 of (1) Diarrhea, (2) Vomiting, (3) Fever, (4) Nausea, (5) Anaphylaxis

The subjects enrolled in the study are cancer patients, who were treated with anticancer drugs before, and possibly during, DKC immunotherapy. Potential adverse drug-drug interaction (DDI) is monitored during treatment and follow-up period.

For each cohort, there are 5 baselines (taken 9 days before infusion) for 5 infusion cycles, and there are 2 evaluation time points in each infusion cycle (at end of first week and second week after infusion) and 4 in the follow-up period (at every 12 weeks). The laboratory evaluation results are tabulated in two aspects: 1) the percentage changes between each evaluation and corresponding baselines, and 2) the mean baseline values of each cycle in each cohort. Laboratory results regarding different functional categories are described separately in following areas.

Hematology related items: Hb (g/dL), WBC (count/uL), Platelet (x 10\^3 count/uL), ANC (count/uL)

Liver function related items: C-RP (mg/dL), Glucose AC (mg/dL), Total Bilirubin (mg/dL), AST (U/L), ALT (U/L), LDH (U/L), ALP (U/L), gammaGT (U/L)

Serum lipids and proteins, renal function, and electrolytes related items: HDL-C (mg/dL), Total Cholesterol (mg/dL), Triglyceride (mg/dL), Creatinine (mg/dL), BUN (mg/dL)

The tumor specific T cell response was assessed by the detection of CD3+CD8+CD69+IFN-gamma+ T lymphocytes in percentage relative to total peripheral blood mononuclear cells (PBMCs). Baseline value was measured before first infusion cycle, and subsequent evaluation time points were measured right after infusion cycles 2, 3, and 4.

The quality of life as assessed by the WHO QoL-BREF questionnaire, and the transformed scores (0-100) was used to facilitate the interpretation. Baseline value was measured before first infusion cycle, and evaluation time points were taken right after infusion cycles 2, 3, 4, and 5. During the follow-up period, evaluation time points were taken at every 12 weeks for a total of 4 time points.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase I Study of Image-Guided Radiation Concurrent With Double-Agent Chemotherapy for Hepatocellular Carcinoma	NCT02403544	Carcinoma, Hepa...	IGRT Capecitabine Oxaliplatin	18 Years - 65 Years	ChineseAMS
177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours	NCT04375267	Clinical Trial,... Neuroendocrine ... Thymoma Mesothelioma	177Lu-DOTA-TATE...	18 Years -	Vastra Gotaland Region
ADC-1013 First-in-Human Study	NCT02379741	Neoplasms Solid Tumors	ADC-1013	18 Years -	Alligator Bioscience AB
Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2	NCT00034281	Breast Neoplasm Pancreatic Neop... Lung Neoplasm Ovarian Neoplas... Renal Neoplasm	TAK-165	18 Years -	Takeda
Safety and Tolerability Study of TAK-165 in Subjects With Tumors Expressing HER2	NCT00034281	Breast Neoplasm Pancreatic Neop... Lung Neoplasm Ovarian Neoplas... Renal Neoplasm	TAK-165	18 Years -	Takeda
Anti-CTLA-4 Antibody Followed by Anti-PD-1 Antibody in Recurrent or Metastatic NSCLC	NCT03527251	Non Small Cell ...	Ipilimumab SHR-1210	18 Years -	Sun Yat-sen University
Hormone Receptor Positive endometrIal Carcinoma Treated by Dual mTORC1/mTORC2 Inhibitor and Anastrozole (VICTORIA)	NCT02730923	Endometrial Car... Metastatic Carc... Hormone Recepto...	AZD2014 Anastrozole	18 Years -	Centre Leon Berard
Dendritic Killer Cell-based Immunotherapy for Solid Tumors	NCT02882659	Colorectal Neop... Hepatocellular ... Neoplasm Metast...	Dendritic Kille...	20 Years -	FullHope Biomedical Co., Ltd.
177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours	NCT04375267	Clinical Trial,... Neuroendocrine ... Thymoma Mesothelioma	177Lu-DOTA-TATE...	18 Years -	Vastra Gotaland Region
Phase I Study of Image-Guided Radiation Concurrent With Double-Agent Chemotherapy for Hepatocellular Carcinoma	NCT02403544	Carcinoma, Hepa...	IGRT Capecitabine Oxaliplatin	18 Years - 65 Years	ChineseAMS
Dendritic Killer Cell-based Immunotherapy for Solid Tumors	NCT02882659	Colorectal Neop... Hepatocellular ... Neoplasm Metast...	Dendritic Kille...	20 Years -	FullHope Biomedical Co., Ltd.

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