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

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ClinicalTrials.gov Identifier: NCT01692197
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : June 15, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Leukemia Drug: E7070 Drug: Idarubicin Drug: Cytarabine Drug: Dexamethasone Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of E7070, Idarubicin and Cytarabine in Patients With Relapsed or Refractory Acute Myeloid Leukemia and High-risk Myelodysplastic Syndromes
Actual Study Start Date : February 1, 2013
Primary Completion Date : June 7, 2017
Study Completion Date : June 7, 2017


Arms and Interventions

Arm Intervention/treatment
Experimental: Stage 1: E7070
Stage 1: E7070 400 mg/m2 by vein (IV) over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only). If at assessment participant found to be in CR, CRp, PR or marrow clearance of blasts, they may receive post-remission therapy with E7070 400 mg/m2 IV over 1 hour on day 1 and day 8 (+/- 2 days on Day 8 only) every 3 weeks for up to five additional cycles as long as clinical benefit continues.
Drug: E7070
400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.
Experimental: Stage 2: E7070 + Idarubicin + Cytarabine
Stage 2: 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
400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.
Drug: Idarubicin
8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).
Other Name: Idamycin
Drug: Cytarabine
1.0 g/m2 by vein daily on Days 9 - 12 (age <60 years) or Days 9 - 11 (age > 60 years).
Other Names:
  • ARA-C
  • Cytosar
  • DepoCyt
  • Cytosine Arabinosine Hydrochloride
Drug: Dexamethasone
10 mg by vein daily for 3 - 4 days with cytarabine.
Other Name: Decadron


Outcome Measures

Primary Outcome Measures :
  1. Overall Response [ Time Frame: 21 days ]
    Efficacy measured by overall response - complete response plus complete response with incomplete platelet recovery, plus partial response (CR + CRp + PR+ marrow clearance of blast) during Stage 1 and 2.

  2. Toxicity Profile [ Time Frame: 28 days ]
    Bayesian sequential monitoring method (Thall, 1995) used to monitor toxicity. Toxic event defined as death or a CTCAE 4.0 grade 3/4 non-hematological toxicity related to study drug lasting or 7 days or more. Toxicity reported by type, frequency and severity. Worst toxicity grades per patient tabulated for selected adverse events and laboratory measurements.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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 IPSS or >10% blasts in marrow).
  2. Patients must be 18 years or older.
  3. Patients must have a performance status of 0-2 (Zubrod scale).
  4. 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.
  5. Patients must have adequate hepatic function (bilirubin less than or equal to 2.0 mg/dl; SGOT or serum glutamate pyruvate transaminase (SGPT) less than or equal to 3X 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.
  6. Patients must have normal cardiac ejection fraction
  7. Corrected QT interval (QTc) interval </= 480 msecs.
  8. 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.
  9. 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.

Exclusion Criteria:

  1. Patients must not have untreated or uncontrolled life-threatening infection.
  2. 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.
  3. 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.
  4. Patients must not have received an investigational anti-cancer drug within two weeks of E7070 administration.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692197


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Eisai Inc.
Investigators
Principal Investigator: Gautam Borthakur, MBBS M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01692197     History of Changes
Other Study ID Numbers: 2009-0570
NCI-2012-02065 ( Registry Identifier: NCI CTRP )
First Posted: September 25, 2012    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Acute Myeloid Leukemia
Acute Myelogenous Leukemia
AML
Relapsed or Refractory
High-Risk Myelodysplastic Syndromes
HRMDS
E7070
Idarubicin
Idamycin
Cytarabine
ARA-C
Cytosar
DepoCyt
Cytosine Arabinosine Hydrochloride
Dexamethasone
Decadron

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Dexamethasone acetate
Dexamethasone
Cytarabine
Idarubicin
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents