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A Phase 2 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in the Treatment of Patients With Platinum-Refractory or Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Carcinoma

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Trial Information

A Phase 2 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in the Treatment of Patients With Platinum-Refractory or Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma


Inclusion Criteria:



1. Female patients 18 years or older

2. Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or
primary peritoneal carcinoma.

3. Eastern Cooperative Oncology Group performance status 0 or 1

4. Postmenopausal at least 1 year, OR

- Surgically sterile, OR

- If childbearing potential, agree to 2 effective methods of nonhormonal
contraception, or agree to completely abstain from heterosexual intercourse

5. Able to provide written informed consent.

6. Within 7 days before study:

- Absolute neutrophils (ANC) ≥ 1,500/μL

- Platelets ≥100,000/ μL

- Total bilirubin must be < 1.5 times upper limit of the normal (ULN)

- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be ≤ 2.5
times the ULN. AST and ALT may be elevated up to 5 times the ULN if ascribed to
metastatic liver disease.

- Creatinine clearance ≥ 30 mL/minute

7. Platinum-refractory or -resistant disease

8. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) OR CA 125
level of > 40 units/mL AND clinical evidence disease

9. Recovered from effects of prior therapy

Exclusion Criteria:

1. Pregnant or lactating

2. Serious illness that could interfere with protocol completion

3. Investigational treatment 28 days prior to first dose.

4. Maximum 4 prior systemic therapies: 2 platinum-based, 1 nonplatinum cytotoxic, 1
biological

5. Known Central Nervous System metastases

6. Prior allogeneic bone marrow or organ transplantation

7. Radiotherapy within 21 days prior to first dose

8. Radiotherapy to > 25% bone marrow

9. Major surgery, infection requiring systemic antibiotic therapy within 14 days prior
to first dose

10. Inability to swallow orally administered medication

11. Diagnosis or treatment of another malignancy within 2 years preceding first dose of
study drug except nonmelanoma skin cancer or in situ malignancy completely resected

12. Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or
hepatitis C.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Combined objective response rate, defined as complete response + partial response by Response Evaluation Criteria in Solid Tumors criteria or response by CA 125 criteria

Outcome Time Frame:

CT or MRI every 2 cycles (6 weeks) to 12 months until progressive disease

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C14006

NCT ID:

NCT00853307

Start Date:

March 2009

Completion Date:

June 2011

Related Keywords:

  • Ovarian Carcinoma
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Summit Medical GroupSummit, New Jersey  07901