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A Phase I Open-Label, Single-Arm, Dose Escalation Study of E7107 Administered Intravenously on Days 1 and 8 Every 21 Days to Patients With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

A Phase I Open-Label, Single-Arm, Dose Escalation Study of E7107 Administered Intravenously on Days 1 and 8 Every 21 Days to Patients With Solid Tumors

Inclusion Criteria


INCLUSION CRITERIA:

Patients must meet all of the inclusion criteria outlined below in order to be eligible to
participate in the study.

1. Patients with histologically and/or cytologically confirmed solid tumors who have
progressed after receiving approved therapies for their disease and for whom no
effective therapies are available.

2. Surgery and radiotherapy must have been completed at least four weeks prior to study
entry, and prior chemotherapy and other anti-cancer therapy, excluding
bisphosphonates at a steady dose level, must have been discontinued 2 to 3 weeks
previously. All acute toxicities related to these treatments must have resolved.

3. Aged ≥ 18 years

4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

5. Written informed consent prior to any study specific screening procedures, which will
include mandatory consent to provide a blood sample specifically for pharmacogenomic
analysis, with the understanding that the patient may withdraw consent at any time
without prejudice. Tumor biopsy for pharmacogenomic (PG) analysis will be voluntary.

6. Willing and able to comply with the protocol for the duration of the study.

7. Anticipated life expectancy > three months.

EXCLUSION CRITERIA:

Patients with the following characteristics will not be eligible for the study.

1. Symptomatic or progressive brain tumors or brain or leptomeningeal (CNS) metastases
requiring clinical intervention, except if they have completed local therapy and have
discontinued the use of corticosteroids for this indication for at least two weeks
before starting treatment with E7107.

2. Any of the following laboratory parameters:

1. hemoglobin < 9 g/dL (5.6 mM)

2. neutrophils < 1.5 x 10^9/L

3. platelets < 100 x 10^9/L

4. serum bilirubin > 25 μM (1.5 mg/dL)

5. liver function tests (defined as AST and ALT) with values > 3 x ULN (5 x ULN if
liver metastases are present)

6. serum creatinine > 1.5 x ULN or creatinine clearance < 40 mL/min.

3. Positive history of HIV, active hepatitis B or active hepatitis C or
severe/uncontrolled intercurrent illness or infection.

4. Clinically significant cardiac impairment or unstable ischemic heart disease (greater
than Class II according to New York Heart Association (NYHA) classification)
including a myocardial infarction within six months of study start.

5. Bleeding or thrombotic disorders, or using therapeutic dosages of anticoagulants

6. History of alcoholism, drug addiction, or any psychiatric or psychological condition
which, in the opinion of the Investigator, would impair study compliance.

7. Women who are pregnant or breast-feeding. Women of childbearing potential with either
a positive serum pregnancy test at screening, a positive urine pregnancy test at the
beginning of any cycle, or no pregnancy test. Women of childbearing potential unless
using two forms of contraception, one of which must be a barrier method.
Postmenopausal women must be amenorrheic for at least 12 months to be considered of
non-childbearing potential.

8. Fertile men and fertile women who are not willing to use contraception, or fertile
men or fertile women with a partner who is not willing to use contraception

9. Patients with a marked screening or baseline prolongation of QT/QTc interval using
the Fridericia formula (ie, repeated demonstration of a QTc interval > 450 msec); a
history of additional risk factors for Torsade de Pointe (e.g., heart failure,
hypokalaemia, history of Long QT Syndrome).

10. Patients who have had radiation to >= 25% of their bone marrow (e.g., pelvic
radiation).

11. Patients who have a history of previous Grade 2 or higher hypersensitivity to
pladienolide B or derivatives and excipients of the formulation

12. Patients with significant comorbid disease or condition, which in the Investigator's
opinion would exclude the patient from the study

13. Patients who have received an organ allograft ie, requiring immunosuppressive therapy

14. Beginning two weeks prior to dosing, patients are not allowed to take drugs that are
strong CYP inhibitors (including grapefruit juice and herbal supplements) or inducers
(including herbal supplements), or are metabolized by cytochrome P (CYPs) and known
to have a narrow therapeutic window.

15. After MTD has been reached: Second malignancy within the past 5 years, except for
carcinoma in situ of the cervix, basal cell carcinoma of the skin.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tumor assessments should be performed at screening and then every 2 cycles. A best response according to RECIST (Response Evaluation Criteria in Solid Tumors) will be documented by the investigator for each patient.

Outcome Time Frame:

Every 6 weeks

Safety Issue:

Yes

Principal Investigator

Ewa Matczak

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.

Authority:

United States: Food and Drug Administration

Study ID:

E7107-A001-101

NCT ID:

NCT00499499

Start Date:

July 2007

Completion Date:

August 2010

Related Keywords:

  • Cancer
  • Cancer
  • solid tumors

Name

Location

M.D. Anderson Cancer Center Houston, Texas  77030
Karmanos Cancer Center Detroit, Michigan  48201