Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Analgesics

Etoposide

Cytarabine

Mitoxantrone

Sirolimus

Etoposide phosphate

Temsirolimus

MTOR Inhibitors

Enzyme Inhibitors

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Clotrimazole

Miconazole

Antifungal Agents

Protein Kinase Inhibitors

Rapamycin loading dose of 12 mg followed by a single daily dose for 8 days of 4 mg/day + MEC (Mitoxantrone 8 mg/m2/day IV, Etoposide 100 mg/m2/day IV and Cytarabine 1000 mg/m2 IV every 24 hours for 5 days. Starts after 4th dose of sirolimus.

Rapamycin, Mitoxantrone, Etoposide, Cytarabine

Rapamycin + MEC

The purpose of this study is to evaluate the side effects of sirolimus (rapamycin) given in combination with chemotherapy (Mitoxantrone + Etoposide + Cytarabine (MEC)) on high risk myeloid leukemias.

Sirolimus in Combination With MEC in High Risk Myeloid Leukemias

A Prospective Single Institution Pilot Study Evaluating the Pharmacokinetics of Sirolimus in Combination With MEC (Mitoxantrone + Etoposide + Cytarabine) in Patients With High Risk Leukemias

Abramson Cancer Center at Penn Medicine

Symptoms and General Pathology

Heart and Blood Diseases

Vomiting

Thromboembolism

Signs and Symptoms, Digestive

Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Antiemetics

Gastrointestinal Agents

Emetics

Aprepitant

HEC or MEC

Describe cardiovascular events in a cancer population receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

CV Events in Emetogenic Chemotherapy

Cardiovascular Events in Cancer Patients Receiving Highly Emetogenic or Moderately Emetogenic Chemotherapy

GlaxoSmithKline

Syndrome

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Prexasertib

* Cytarabine is administered intravenously on days 1-5.
* Etoposide is administered intravenously on days 1-5.
* Mitoxantrone is administered intravenously on days 1-5.
* Prexasertib is administered intravenously on days 1, 3, and 5.

Standard chemotherapy (topoisomerase inhibitor)

Standard chemotherapy (topoisomerase II inhibitor)

Eric S Winer, MD

This research study is studying a targeted therapy combined with chemotherapy as a possible treatment for acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS).

The drugs involved in this study are:

* Prexasertib (LY2606368)
* Mitoxantrone
* Etoposide
* Cytarabine

This research study is a Phase I clinical trial, which tests the safety of an investigational drug or combination of drugs and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the drug is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved prexasertib as a treatment for any disease. Prexasertib is a checkpoint kinase 1 (CHK1) inhibitor that is being developed as a treatment for patients with advanced cancer. CHK1 inhibitors work by preventing cancer cells from being able to repair damaged DNA (one of the building blocks of a cell) which then leads to cell death.

The drugs mitoxantrone, etoposide, and cytarabine (MEC) have all been approved by the FDA. MEC is a standard chemotherapy treatment option, commonly used for AML that has not responded to other standard treatment or returned following standard treatment.

In this research study, the investigators are combining prexasertib with MEC therapy to test if it is a safe treatment for AML or MDS that has returned or not responded to standard treatment.

Prexasertib in Combination With MEC in Relapsed/Refractory AML and High Risk MDS - a Phase I Trial

Prexasertib in Combination With Mitoxantrone, Etoposide and Cytarabine (MEC) in Relapsed/Refractory Acute Myeloid Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) - a Phase I Trial

Toxicities occurring following administration of protocol therapy, measured using CTCAE 5.0 criteria.

Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for the study drug combination.

Rates of complete remission (CR), complete remission with incomplete count recovery (CRi), and partial remission (PR).

Assess the overall survival rate for the combination.

Time of achievement of CR or CRi to relapse, death, or 1 year (whichever occurs first)

Eli Lilly and Company

Dana-Farber Cancer Institute

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sirolimus in Combination With MEC in High Risk Myeloid Leukemias	NCT00780104	Myeloid Leukemi... AML Leukemia CML	Rapamycin, Mito... Rapamycin + MEC	18 Years -	Abramson Cancer Center at Penn Medicine
Sirolimus in Combination With MEC in High Risk Myeloid Leukemias	NCT00780104	Myeloid Leukemi... AML Leukemia CML	Rapamycin, Mito... Rapamycin + MEC	18 Years -	Abramson Cancer Center at Penn Medicine
CV Events in Emetogenic Chemotherapy	NCT01366599	Vomiting Cardiovascular ... Arterial Thromb...	HEC or MEC	-	GlaxoSmithKline
Prexasertib in Combination With MEC in Relapsed/Refractory AML and High Risk MDS - a Phase I Trial	NCT03735446	Acute Myeloid L... Myelodysplastic...	Prexasertib Mitoxantrone Etoposide Cytarabine	18 Years -	Dana-Farber Cancer Institute
Sirolimus in Combination With MEC in High Risk Myeloid Leukemias	NCT00780104	Myeloid Leukemi... AML Leukemia CML	Rapamycin, Mito... Rapamycin + MEC	18 Years -	Abramson Cancer Center at Penn Medicine
Sirolimus in Combination With MEC in High Risk Myeloid Leukemias	NCT00780104	Myeloid Leukemi... AML Leukemia CML	Rapamycin, Mito... Rapamycin + MEC	18 Years -	Abramson Cancer Center at Penn Medicine

Spots Global Cancer Trial Database for mec

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

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