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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

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


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 through a
needle in your vein over 1 hour on Day 1 and Day 8 (+/- 2 days on Day 8 only) of Stage 1.

If, after Cycle 1 of Stage 1, your doctor thinks you are benefitting from taking the study
drug alone, you may continue to receive E7070 on Days 1 and 8 (+/- 2 days on Day 8 only) of
each cycle for up to 5 additional cycles. A cycle is defined as 3 weeks. Your dose may be
changed or delayed depending on how you are tolerating the study drug.

If the disease is not responding to E7070 alone after Cycle 1 of Stage 1, you will receive
E7070 by vein over 1 hour on Day 1 and Day 8 (+/- 2 days on Day 8 only) of Stage 2 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 older than 60 years of age, 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.

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 Stage 1 and 2, 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 21 (+/- 2 days) of Cycle 1 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 Days 2 and 9.

Treatment cycles beyond cycle 1 of Stage 1 and/or 2, 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 you receive E7070 alone (Stage 1) while you are on study, you may receive E7070 for up to
6 cycles.

If you begin receiving E7070 in combination with idarubicin, cytarabine, and dexamethasone
(Stage 2), you may receive the study drug combination for up to 3 cycles (a total of 4
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/study drug combination. You will
also be asked about any side effects you may have had.

Long Term Follow-up:

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.


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 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. QTc interval
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 (for up to 2 weeks immediately prior to start of study
drug).

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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response

Outcome Description:

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. The sample size and stopping rules determined according to Simon's two-stage design. Overall response (CR + CRp + PR) rate and its 95% confidence interval estimated using a binomial distribution. Overall survival and progression free survival functions estimated using the Kaplan-Meier method.

Outcome Time Frame:

21 days

Safety Issue:

No

Principal Investigator

Gautam Borthakur, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2009-0570

NCT ID:

NCT01692197

Start Date:

February 2013

Completion Date:

Related Keywords:

  • Leukemia
  • 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
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030