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

NCT01692197 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2009-0570NCI-2012-02065
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia

Keywords

Leukemia; Acute Myeloid Leukemia; Acute Myelogenous Leukemia; AML; Relapsed or Refractory; High-Risk Myelodysplastic Syndromes; HRMDS; E7070; Idarubicin; Idamycin; Cytarabine; Cytarabine (ARA-C); Cytosar; DepoCyt; Cytosine Arabinosine Hydrochloride; Dexamethasone; Decadron

Outcome Measures

Primary Outcomes (1)

• Overall Response

  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.

  2 cycles (60 days)

Secondary Outcomes (3)

• Disease-free Survival

  Up to 5 years

• Duration of Response

  Up to 5 years

• Overall Survival

  Up to 5 years

Study Arms (1)

E7070 + Idarubicin + Cytarabine

EXPERIMENTAL

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.

Drug: E7070; Drug: Idarubicin; Drug: Cytarabine; Drug: Dexamethasone

Interventions

E7070 DRUG

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

E7070 + Idarubicin + Cytarabine

Idarubicin DRUG

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

Also known as: Idamycin

E7070 + Idarubicin + Cytarabine

Cytarabine DRUG

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

Also known as: ARA-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride

E7070 + Idarubicin + Cytarabine

Dexamethasone DRUG

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

Also known as: Decadron

E7070 + Idarubicin + Cytarabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (AML) \[except acute promyelocytic leukemia\], or high-risk myelodysplastic syndrome (HRMDS) (Int-2 high risk by International Prostate Symptom Score (IPSS) or \>10% blasts in marrow).
• Patients must be 18 years or older.
• Patients must have a performance status of 0-2 (Zubrod scale).
• Patients must have adequate renal function (serum creatinine less than or equal to 1.3 mg/dL and/or creatinine clearance \> 40 mL/min). Patients with renal dysfunction due to organ infiltration by disease may be eligible after discussion with the Principal Investigator (PI) (up to creatinine less than or equal to 2.0), and appropriate dose adjustments will be considered.
• Patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; SGOT or Serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 times the ULN for the reference lab unless due to leukemia or congenital hemolytic disorder or bilirubin). Patients with hepatic dysfunction (SGOT/SGPT up to less than or equal to 5 X ULN) due to organ infiltration by disease may be eligible after discussion with the PI, and appropriate dose adjustments will be considered.
• Patients must have normal cardiac ejection fraction
• QTc interval \</= 480 msecs.
• Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
• Female patients must not be pregnant or lactating. Female patients of childbearing potential (including those \<1 year post-menopausal) and male patients must agree to use contraception.

You may not qualify if:

• Patients must not have untreated or uncontrolled life-threatening infection.
• Patients must not have received chemotherapy and/or radiation therapy within 2 weeks. Hydroxyurea is allowed up to 48 hours prior to starting therapy in the setting of rapidly proliferating disease. Use of hydroxyurea to control proliferative disease will be allowed starting from day 2 until day 7 Cycle 1. Maximum dose of hydroxyurea allowed daily is 5 gram and hydroxyurea must be discontinued once administration of idarubicin and cytarabine is started.
• Any other medical condition, including mental illness or substance abuse, deemed by the PI to be likely to interfere with a patient's ability to sign informed consent or cooperate and participate in the study or with the interpretation of the results.
• Patients must not have received an investigational anti-cancer drug within two weeks of E7070 administration.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Eisai Inc.: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Recurrence

Interventions

N-(3-chloro-7-indolyl)-1,4-benzenedisulphonamide; Idarubicin; Cytarabine; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Borthakur,Gautam MD
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-563-1586

Study Officials

• Gautam Borthakur, MBBS

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 25, 2012
• Study Start: February 1, 2013
• Primary Completion: June 7, 2017
• Study Completion: June 7, 2017
• Last Updated: July 3, 2018
• Results First Posted: July 3, 2018

Record last verified: 2018-06

Locations

US (1)