Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

In Phase Ib study, patients will receive gimatecan at different dose level (0.4mg/m2, 0.6mg/m2,0.8mg/m2, oral, every 4 weeks) until progressive disease (PD).In Phase II study, patients will receive gimatecan at recommended phase II dose level.

Patients will receive gimatecan orally at the recommended dose level on day 1-5 every 4 weeks.

Gimatecan

LIU XIAOQING, MD

This phase Ib/II clinical trial studies the safety and effect of Gimatecan in small cell lung cancer patients who failed the first-line standard platinum-containing chemotherapy. The chemotherapy will be given every four weeks.

A Study of Gimatecan (ST1481) in Small Cell Lung Cancer

A Phase Ib/II Study of Gimatecan (ST1481) for Small Cell Lung Cancer Patients Who Failed Standard Platinum-containing Chemotherapy

Phase Ib: Number of patients experienced any dose limited toxicity over the DLT period.

Phase Ib: Determination of recommended phase II dose of escalating dose of gimatecan for the phase II part of the study.

Percentage of patients with objective response assessed by best overall response (BOR) of either complete response(CR) or partial remission(PR) will be reported.

The 2-year progression free survival of the whole group.

Percentage of patients with disease control as assessed by best overall response (BOR) of either complete response(CR), partial remission(PR) or stable disease (SD) will be reported.

The DoR applies only to patients whose BOR is either CR or PR. The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).

The 2-year overall survival of the whole group.

Survival probability of patients calculated according to Kaplan-Meier curve at either 1 or 2 year.

The incidence rate of treatment related adverse events of the whole group assessed by CTCAE v5.0.

Lee's Pharmaceutical Limited

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Glioma

Glioblastoma

Brain Neoplasms

Astrocytoma

Oligodendroglioma

Central Nervous System Neoplasms

Nervous System Neoplasms

Gliosarcoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Brain Tumor, Adult

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Neuroepithelioma

gimatecan

Timothy F. Cloughesy, MD

RATIONALE: Drugs used in chemotherapy, such as gimatecan, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase I/II trial is studying the side effects and best dose of gimatecan in treating patients with recurrent or progressive primary malignant glioma.

OBJECTIVES:

Primary

* Determine the maximum tolerated dose (MTD) of gimatecan in patients with recurrent or progressive primary malignant glioma treated with or without concurrent enzyme-inducing anticonvulsant drugs.
* Determine whether this drug has sufficient activity to warrant further development in these patients. (phase II)

Secondary

* Determine the qualitative and quantitative toxic effects of this drug in these patients.
* Determine the pharmacokinetic behaviors of this drug in these patients.
* Correlate the principal toxic effects with the pertinent pharmacokinetic parameters of this drug in these patients.
* Determine the antitumor activity of this drug in these patients.

OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients are stratified according to the concurrent use of enzyme-inducing anticonvulsant drugs (yes vs no).

* Phase I: Patients receive oral gimatecan once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of gimatecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

* Phase II: Patients receive gimatecan as in phase I at the MTD. Patients are followed for at least 1 month and then every 2 months thereafter.

PROJECTED ACCRUAL: Approximately 30-83 patients (30-42 for phase I \[15-21 per stratum\] and 21-41 for phase II) will be accrued for this study within 24 months.

Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma

Oral ST1481 in Adults With Malignant Glioma: A Phase I-II Clinical Trial

National Cancer Institute (NCI)

Jonsson Comprehensive Cancer Center

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Tegafur

Antimetabolites

All patients will receive gimatecan (0.8mg/m2, on days 1 to 5, PO, every 4 weeks) until progressive disease (PD).

All patients will receive tegafur, gimeracil and oteracil potassium (40-60mg, twice daily, on days 1 to 14 , PO, every 3 weeks) or gemcitabine (1000mg/m2, on days 1、8, IV, every 3 weeks) until progressive disease (PD).

Patients will receive gimatecan orally at 0.8mg/m2 on day 1-5 every 4 weeks.

Patients will receive tegafur, gimeracil and oteracil potassium orally at 40 or 60mg twice daily on days 1 to 14 every 3 weeks.

tegafur, gimeracil and oteracil potassium

Patients will receive gemcitabine IV at 1000mg/m2 on days 1、8 every 3 weeks.

gemcitabine

WANG LIWEI, MD

This phase II clinical trial studies the safety and effect of as second-line treatmen in local advanced or metastatic pancreatic cancer. The Gimatecan will be given every four weeks.

A Phase II Study of Gimatecan (ST1481) in Locally Advanced or Metastatic Pancreatic Cancer

Gimatecan (ST1481) as Second-line Treatment for Locally Advanced or Metastatic Pancreatic Cancer: an Open-label, Randomized, Controlled Phase II Study

Percentage of patients with objective response assessed by best overall.

The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).

Percentage of patients with disease control as assessed by best overall.

Change from baseline assessed according to the quality of life questionnaire C30.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Fallopian Tube Neoplasms

Peritoneal Neoplasms

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

Fallopian Tube Diseases

Abdominal Neoplasms

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

In Phase II study, patients will receive gimatecan at fixed dose level (0.8mg/m2/d, oral, every 4 weeks) until progressive disease (PD)、complete remission（CR）).

Patients will receive gimatecan orally at the fixed dose level on day 1-5 every 4 weeks.

ZHOU QI

This phase II clinical trial studies the safety and effect of Gimatecan in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or peritoneal cancer.

The chemotherapy will be given every four weeks.This study is a single-arm, multi-center research design.

The study had 3 phases: screening phase, treatment phase and follow-up phase. During the treatment phase, the drug will continue to be administered until the progression of disease, complete remission , unacceptable toxicity.

A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

A Phase II Study of Gimatecan in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Percentage of patients with objective response assessed by best overall response (BOR) and independent review committee （IRC） of either complete response(CR) or partial remission(PR) will be reported.

Topoisomerase I Inhibitors

Novartis Pharmaceuticals

CLBQ707A1101 assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients.

An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor

An Extension Trial to a Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor

Novartis

This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally twice per week, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy dose not exist.

A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors

A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors.

External Affairs

Blood and Lymph Conditions

Syndrome

Leukemia

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Hematologic Diseases

Precancerous Conditions

Gimatecan Starting dose: 0.6 mg capsules administered orally once daily.

Starting dose: 0.6 mg capsules administered orally once daily.

Jorge E. Cortes, MD

The goal of this clinical research study is to find the highest tolerable dose of gimatecan that can be given to treat myelodysplastic syndrome (MDS).

The Study Drug:

Gimatecan is designed to block the function of an important protein (topoisomerase I) in cancer cells that helps repair damage to DNA (the genetic material of cells). When this protein is blocked, cancer cells may die.

Screening Tests:

Before you can start receiving the study drug, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study.

* You will have a physical exam.
* Your complete medical history will be recorded.
* Your vital signs (blood pressure, pulse, breathing rate, and temperature), height, and weight will be measured.
* You will be asked how well you are able to perform the normal activities of daily living (a performance status evaluation).
* You will be asked about any medications you may be taking.
* Blood (about 1 tablespoon) will be drawn for routine tests.
* Women who are able to have children must have a negative blood (about 2 teaspoons) or urine pregnancy test.
* You will have a bone marrow aspirate performed. To collect a bone marrow aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle.
* If your doctor thinks it is necessary, you will have a bone marrow biopsy when you have the bone marrow aspirate done. To collect a bone marrow biopsy, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle.
* You will complete a questionnaire to see how the disease may be affecting your ability to do your daily activities. The questionnaire will take about 15 minutes to complete.

Study Drug Dose Level:

If you are found to be eligible to take part in this study, the amount of study drug you receive will be based on when you join the study. Three (3) to 6 participants will be enrolled in this study and given a certain dose. If they do not experience intolerable side effects, the next 3-6 participants enrolled will receive a higher dose. This process will continue until researchers find the highest dose of the drug that can be given without causing serious or intolerable side effects. The study doctor will tell you what dose you will be receiving and how this compares to the doses other participants have received.

Study Drug Administration:

You will take gimatecan on Days 1-5. On Days 6-28, you will take no study drug. Each 28-day period is called a study "cycle." If your doctor thinks it is necessary, your study cycles may be shortened so that you will receive the study drug more often.

You will take the medication on an empty stomach, swallowing the capsules whole. You should not eat for 1 hour after taking the medication. If you take other medications while you are on this study, they must be taken 4 hours before or after you take gimatecan.

Study Visits:

Blood (about 2 tablespoons each time) will be drawn for routine tests every 1-4 weeks for the length of this study. Most of these blood tests will be done once a week, but some will only be done once every 4 weeks.

You will have a physical exam every 4 weeks for the first 3 months, then every 3 months.

At the end of Cycle 1, and then every 9-12 weeks after that, you will have a bone marrow aspirate and/or biopsy. Bone marrow biopsies and aspirates may be collected more often if your study doctor thinks it is necessary.

Once per week for the first 3 cycles, you will complete a symptom questionnaire. This will be done either at a study visit, or you will be called by a member of study staff. The questionnaire will take about 15 minutes to complete.

Length of Study:

You can remain on this study for up to 12 months. If, after this time, it is considered that gimatecan is helping you, the study doctor will discuss the possibility of continuing the study drug therapy outside of this study. You may be taken off this study early if the disease gets worse or intolerable side effects occur.

End-of-Study Visit:

Once you are off this study, you will have an end-of-study visit, and the following tests will be performed.

* You will have a physical exam.
* You will be asked about any side effects you may be experiencing.
* Blood (about 4 teaspoons) will be drawn for routine tests.
* You will repeat the symptom questionnaire.

This is an investigational study. Gimatecan is not FDA approved or commercially available. It has been authorized for use in research only. Up to 30 patients will take part in this study. All will be enrolled at M. D. Anderson.

Phase I Study of Gimatecan in Patients With Myelodysplastic Syndromes

For purposes of estimating the MTD, 5 dose levels of Gimatecan initially considered. These dose levels are 3 mg, 5 mg, 7.5 mg, 8.75 mg, and 10 mg orally per cycle. Dose escalation based on toxicities observed through the first cycle.

Response criteria according to the International Working Group (Blood 2006; 108: 419-425). Responders are patients who obtain a Complete Response (CR), CRi, Partial Response (PR), with or without cytogenetic response, hematologic improvements, and morphologic leukemia-free state.

M.D. Anderson Cancer Center

This study assesses the tolerability, safety, efficacy and pharmacokinetics of gimatecan in Japanese patients. Gimatecan is administered orally for five consecutive days, every 28 days, to adult patients with advanced solid tumors who have progressed despite standard therapy or for whom standard systemic therapy does not exist.

A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.

A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor.

This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors

Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Gimatecan (ST1481) in Small Cell Lung Cancer	NCT04501029	Small Cell Lung...	Gimatecan	18 Years - 75 Years	Lee's Pharmaceutical Limited
Gimatecan in Treating Patients With Recurrent or Progressive Primary Malignant Glioma	NCT00087061	Brain and Centr...	gimatecan	18 Years -	National Cancer Institute (NCI)
A Phase II Study of Gimatecan (ST1481) in Locally Advanced or Metastatic Pancreatic Cancer	NCT04571489	Pancreatic Canc...	Gimatecan tegafur, gimera... gemcitabine	18 Years -	Lee's Pharmaceutical Limited
A Study of Gimatecan (ST1481) in Small Cell Lung Cancer	NCT04501029	Small Cell Lung...	Gimatecan	18 Years - 75 Years	Lee's Pharmaceutical Limited
A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer	NCT04846842	Epithelial Ovar... Fallopian Tube ... Peritoneal Canc...	Gimatecan	18 Years -	Lee's Pharmaceutical Limited
An Extension Trial to a Phase I Dose Escalation Study of Gimatecan Administered Orally 5 Consecutive Days to Japanese Patients With Advanced Solid Tumor	NCT00441610	Advanced Solid ...	Gimatecan	20 Years -	Novartis
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors	NCT00487058	Advanced Solid ...	Gimatecan	20 Years -	Novartis
A Phase II Study of Gimatecan (ST1481) in Locally Advanced or Metastatic Pancreatic Cancer	NCT04571489	Pancreatic Canc...	Gimatecan tegafur, gimera... gemcitabine	18 Years -	Lee's Pharmaceutical Limited
Phase I Study of Gimatecan in Patients With Myelodysplastic Syndromes	NCT00493571	Myelodysplastic... MDS	Gimatecan	18 Years -	M.D. Anderson Cancer Center
A Dose Escalation of Gimatecan Administered Orally to Japanese Patients With Advanced Solid Tumor.	NCT00410358	Advanced Solid ...	Gimatecan	20 Years -	Novartis
A Phase I Dose Escalation Study of LBQ707 (Gimatecan) Administered Orally Twice Per Week to Japanese Patients With Advanced Solid Tumors	NCT00487058	Advanced Solid ...	Gimatecan	20 Years -	Novartis
Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors	NCT00420485	Solid Tumors	gimatecan	18 Years -	Novartis

Spots Global Cancer Trial Database for gimatecan

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

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