Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Irinotecan

Leucovorin

Fluorouracil

Oxaliplatin

N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide

Carbonic Anhydrase Inhibitors

Enzyme Inhibitors

E7070

Jantien Wanders

The overall purpose of this study is to determine the efficacy, safety and tolerability of indisulam in combination with irinotecan as a treatment for patients with metastatic colorectalcancer previously treated with 5-fluorouracil/leucovorin and oxaliplatin (FOLFOX).

An Open Label Phase II Study of Indisulam in Combination With Irinotecan in Patients With Metastatic Colorectal Cancer Who Have Been Previously Treated With 5-Fluorouracil/Leucovorin and Oxaliplatin

Eisai Limited

Topoisomerase I Inhibitors

Active combination of E7070 and irinotecan.

Escalating doses starting from 125 mg/m2 irinotecan plus 250 mg/m2 E7070 combination.

E7070 + irinotecan combination

Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.

Irinotecan + E7070 combination

Eisai Medical Services

E7070 and irinotecan will be administered to patients with GI tract, pancreatic or lung tumors on Days 1 and 8 of a 21-day cycle, or Days 1 and 15 of a 28-day cycle according to one of two E7070 dose escalation schemes.

Dose-Finding Study of E7070 in Combination With Irinotecan

Phase I Dose-Finding Study of E7070 in Combination With Irinotecan

Eisai Inc.

Symptoms and General Pathology

Blood and Lymph Conditions

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Dexamethasone

Cytarabine

Dexamethasone acetate

BB 1101

Idarubicin

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age \<60 years) or days 9-11 (age \> 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.

400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.

8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).

1.0 g/m2 by vein daily on Days 9 - 12 (age \<60 years) or Days 9 - 11 (age \> 60 years).

10 mg by vein daily for 3 - 4 days with cytarabine.

Gautam Borthakur, MBBS

The goal of this clinical research study is to learn if E7070 in combination with idarubicin, cytarabine, and dexamethasone can help to control the disease in patients with either AML or high-risk MDS that has relapsed. The safety of the drug combination will also be studied.

The Study Drugs:

E7070 is designed to stop metabolic ingredients from reaching the cancer cells and to stop the cancer cell from dividing.

Cytarabine is designed to insert itself into DNA (the genetic material of cells) of cancer cells and stop the DNA from repairing itself.

Idarubicin is designed to cause breaks in both strands of DNA (the genetic material of cells).

Dexamethasone is a corticosteroid that is similar to a natural hormone made by your body. Dexamethasone is often given to AML patients in combination with other chemotherapy to treat cancer.

Study Drug Administration:

If you are found eligible to take part in this study, you will receive E7070 by vein over 1 hour on Day 1 and Day 8 (+/- 2 days on Day 8 only) followed by idarubicin by vein over 1 hour on Days 9-11. You will also receive cytarabine by vein over 24 hours each day on Days 9-12. If you are 60 years of age or older, you will only receive cytarabine on Days 9-11. On days that you are receiving the cytarabine infusions, you will also receive dexamethasone by vein over about 30 minutes. You will receive dexamethasone before the cytarabine infusions. Each study cycle is about 28 days.

If your doctor thinks you are benefitting from taking the E7070 in combination with idarubicin, cytarabine, and dexamethasone, you may receive up to 2 additional cycles of the study drug combination.

Study Visits:

During Cycle 1, the following tests and procedures will be performed:

* You will be asked about medications you are taking and side effects you may have had.
* Blood (about 2 teaspoons) will be drawn at least 1 time every week for routine tests and to check your liver and kidney function.
* You will have a bone marrow aspirate on Day 28 (+/- 3 days) to check the status of the disease. You may have additional bone marrow aspirates during Cycle 2 if the doctor thinks it is necessary.
* During Cycle 1 only, you will have an ECG on Day 2 (+/- 1 day) and Day 8 (+/- 2 days).

Treatment cycles beyond Cycle 1, the following tests and procedures will be performed:

* You will be asked about medications you are taking and side effects you may have had.
* Blood (about 2 teaspoons) will be drawn every 2-4 weeks for routine tests.
* You will have a bone marrow aspirate to check the status of the disease whenever the doctor feels it is necessary.

Length of Study:

If the doctor thinks you are benefitting with E7070 in combination with idarubicin, cytarabine and dexamethasone, you may receive 2 additional cycles of therapy (a total of 3 cycles on this study.)

You will be taken off study if the disease gets worse, you experience intolerable side effects, or if the study doctor thinks it is in your best interest.

End-of-Treatment Visit:

At the end of treatment, blood (about 2 teaspoons) will be drawn for routine tests within 30 days (+/- 5 days) of your last dose of the study drug combination. You will also be asked about any side effects you may have had.

Long Term Follow-up (unless you have started on alternative therapy):

Blood (about 1 tablespoon) will be drawn for routine tests every 2-3 months for up to 2 years unless the disease gets worse or you start on another treatment.

This is an investigational study. E7070 is not FDA-approved or commercially available for use in patients with AML or MDS that has relapsed. Its use in this study is considered investigational. Idarubicin, cytarabine, and dexamethasone are FDA-approved and commercially available for use in the treatment of AML. The combination of E7070, idarubicin, cytarabine, and dexamethasone in this study is investigational.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes

A Phase 2 Study of E7070, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes

Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (Complete remission (CR) + Complete remission without platelet recovery (CRp) + Partial Remission (PR)+ marrow clearance of blast) during cycle 1.

Time from date of treatment start until the date of first objective documentation of disease-relapse.

Response date to loss of response or last follow up.

Time from date of treatment start until date of death due to any cause or last follow-up.

M.D. Anderson Cancer Center

E7070 400 mg/m2 intravenously (IV) approximately over 1 hour on day 1 and day 8:

Idarubicin 8 mg/m2 IV approximately over 1 hour daily x 3 (days 9-11) Cytarabine 1.0 g/m2 IV approximately over 24 hours daily on day 9-12 (age \<60 years) or days 9-11 (age ≥ 60 years).

Dexamethasone 10 mg IV daily for 3-4 days with cytarabine (Duration is approximately 28 days).

E7070 and Idarubicin and Cytarabine

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Borthakur,Gautam MD

Overall Response

E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) followed by, Idarubicin 8 mg/m2 IV over 1 hour daily for 3 days (days 9-11) and Cytarabine 1.0 g/m2 IV over 24 hours daily on day 9-12 (age \<60 years) or days 9-11 (age \> 60 years). Dexamethasone 10 mg IV daily for 3-4 days with cytarabine.

E7070: 400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.

Idarubicin: 8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).

Cytarabine: 1.0 g/m2 by vein daily on Days 9 - 12 (age \<60 years) or Days 9 - 11 (age \> 60 years).

Dexamethasone: 10 mg by vein daily for 3 - 4 days with cytarabine.

E7070 + Idarubicin + Cytarabine

Disease-free Survival

Duration of Response

Overall Survival

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Neoplasm Metastasis

Breast Diseases

Skin Diseases

Capecitabine

Taxane

Sandra Silberman, M.D.

The purpose of this study is to determine if E7070 is an efficacious, safe, and tolerable treatment for patients with metastatic breast cancer who have failed, or could not tolerate, prior treatments with an anthracycline, a taxane, and capecitabine.

Study to Evaluate the Efficacy, Safety, and Tolerability of E7070 in Metastatic Breast Cancer Patients

An Open-Label Phase II Study of E7070 in Metastatic Breast Cancer Patients Previously Treated With an Anthracycline, a Taxane, and Capecitabine

The overall purpose of this study is to compare the efficacy, safety and tolerability of indisulam in combination with capecitabine (IC) versus capecitabine (C) monotherapy in patients with metastatic breast cancer who have previously been treated with an anthracycline and a taxane.

An Open-label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine

An Open-label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine Versus Capecitabine Monotherapy for the Treatment of Metastatic Breast Cancer Patients Following Prior Anthracycline and Taxane Therapy

Stomach Neoplasms

Stomach Diseases

Stomach Cancer

Tatsuo Watanabe

Phase I study:

To investigate primary objective (maximal tolerated dose and dose-limiting toxicity) and secondary objectives (pharmacokinetics, safety, estimation of a recommended dose, and anti-tumor effect by evaluable case) of E7070 in patients with gastric cancer who are extensive or intermediate metabolizer type (EM/IM) to CYP2C9 and CYP2C9 by intravenously administering once every 3 weeks.

Phase IIa study:

To investigate primary objective (response rate for efficacy assessment) and secondary objectives (frequency and severity of adverse drug reactions, and pharmacokinetics) of E7070 in patient with gastric cancer who are EM/IM type by intravenously administering once every 3 weeks.

A Study of E7070 in Patients With Gastric Cancer

Non-Randomized, Open, Uncontrolled, Dose Comparison Study of E7070 in Patients With Gastric Cancer

Eisai Co., Ltd.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Adenocarcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Murray Yule, MRCP, PhD

The purpose of this study is to determine if E7070 is a safe and effective treatment for cancer of the kidneys.

Renal Cell Carcinoma (RCC) accounts for approximately 2% of all cancers and its incidence is increasing with worldwide deaths of over 100,000 patients per year. About 50% of RCC patients have inoperable or metastatic disease that surgery cannot be performed on. RCC is also considered to be resistant to both radiotherapy and cytotoxic chemotherapy. The purpose of this study is to evaluate the safety and effectiveness of E7070 by assessing progression free survival, tumor response rate, duration of response/stable disease, and survival time. E7070 will be administered as a single iv infusion over 60 minutes on Day 1 of each cycle. Patients will continue treatment with E7070 until they no longer have clinical benefit and have disease progression, or toxicity leads to patient withdrawal.

A Safety, Tolerability and Efficacy Study of E7070 in Patients With Renal Cell Carcinoma

A Phase II Study of E7070 in Patients With Progressive Inoperable and/or Metastatic Renal Cell Carcinoma (RCC)

Part 1: The primary purpose is to determine the recommended dose of E7070 in combination with capecitabine by dose adjustment. Part 2: The primary purpose is to determine the safety and efficacy of the combination in patients with metastatic CRC resistant to 5-fluorouracil and irinotecan.

Study of E7070 Combined With Capecitabine to Determine Efficacy and Recommended Dose of Combination in Patients With Metastatic Colorectal Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Open Label Phase II Study of Indisulam in Combination With Irinotecan in Patients With Metastatic Colorectal Cancer Who Have Been Previously Treated With 5-Fluorouracil/Leucovorin and Oxaliplatin	NCT00165867	Colorectal Canc...	E7070	18 Years -	Eisai Inc.
Dose-Finding Study of E7070 in Combination With Irinotecan	NCT00060567	Cancer	E7070 + irinote... Irinotecan + E7... Irinotecan + E7...	18 Years -	Eisai Inc.
E7070, Idarubicin and Cytarabine in Relapsed AML and High-Risk Myelodysplastic Syndromes	NCT01692197	Leukemia	E7070 Idarubicin Cytarabine Dexamethasone	18 Years -	M.D. Anderson Cancer Center
Study to Evaluate the Efficacy, Safety, and Tolerability of E7070 in Metastatic Breast Cancer Patients	NCT00080197	Breast Neoplasm... Metastases	E7070	18 Years -	Eisai Inc.
An Open-label, Randomized, Phase II Study of the Efficacy and Safety of Indisulam (E7070) in Combination With Capecitabine	NCT00165880	Metastatic Brea...	E7070	18 Years -	Eisai Inc.
An Open Label Phase II Study of Indisulam in Combination With Irinotecan in Patients With Metastatic Colorectal Cancer Who Have Been Previously Treated With 5-Fluorouracil/Leucovorin and Oxaliplatin	NCT00165867	Colorectal Canc...	E7070	18 Years -	Eisai Inc.
A Study of E7070 in Patients With Gastric Cancer	NCT00165594	Gastric Cancer	E7070	20 Years - 74 Years	Eisai Inc.
Dose-Finding Study of E7070 in Combination With Irinotecan	NCT00060567	Cancer	E7070 + irinote... Irinotecan + E7... Irinotecan + E7...	18 Years -	Eisai Inc.
A Safety, Tolerability and Efficacy Study of E7070 in Patients With Renal Cell Carcinoma	NCT00059735	Kidney Neoplasm... Carcinoma, Rena... Adenocarcinoma,...	E7070	18 Years -	Eisai Inc.
Study of E7070 Combined With Capecitabine to Determine Efficacy and Recommended Dose of Combination in Patients With Metastatic Colorectal Cancer	NCT00165854	Colorectal Canc...	E7070	18 Years -	Eisai Inc.
A Safety, Tolerability and Efficacy Study of E7070 in Patients With Renal Cell Carcinoma	NCT00059735	Kidney Neoplasm... Carcinoma, Rena... Adenocarcinoma,...	E7070	18 Years -	Eisai Inc.

Spots Global Cancer Trial Database for e7070

Every month we try and update this database with for e7070 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 e7070

Every month we try and update this database with for e7070 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 e7070 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.