MLN8237 for Treatment of Patients With Ovarian, Fallopian Tube, or Peritoneal Carcinoma - Full Text View

Sponsor:	Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00853307

Purpose

This is an open-label, multicenter, single-arm, phase 2 study of MLN8237 in the treatment of patients with platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinomas.

Condition	Intervention	Phase
Ovarian Carcinoma	Drug: MLN8237	Phase 2

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:

Combined objective response rate, defined as complete response + partial response by Response Evaluation Criteria in Solid Tumors criteria or response by CA 125 criteria [ Time Frame: CT or MRI every 2 cycles (6 weeks) to 12 months until progressive disease ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression Free Survival, Duration Of Response, Time To Progression, and clinical benefit rate [ Time Frame: CT or MRI every 2 cycles up to 12 months until progressive disease is documented. Patients who discontinue study drug before progressive disease will be assessed at Follow-Up visits once every 12 weeks up to 12 months, until progressive disease or other ] [ Designated as safety issue: No ]
Adverse events, serious adverse events, assessments of clinical laboratory values, and vital signs measurements [ Time Frame: Clinical exam prior to every cycle (21 days); safety labs weekly ] [ Designated as safety issue: Yes ]

Enrollment:	31
Study Start Date:	March 2009
Study Completion Date:	June 2011
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 MLN8237	Drug: MLN8237 MLN8237 will be given by mouth in a dosage of 50 mg twice a day for 7 Days (Days 1-7) of each 21-day treatment cycle.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female patients 18 years or older
Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
Eastern Cooperative Oncology Group performance status 0 or 1
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
Able to provide written informed consent.
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
Platinum-refractory or -resistant disease
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) OR CA 125 level of > 40 units/mL AND clinical evidence disease
Recovered from effects of prior therapy

Exclusion Criteria:

Pregnant or lactating
Serious illness that could interfere with protocol completion
Investigational treatment 28 days prior to first dose.
Maximum 4 prior systemic therapies: 2 platinum-based, 1 nonplatinum cytotoxic, 1 biological
Known Central Nervous System metastases
Prior allogeneic bone marrow or organ transplantation
Radiotherapy within 21 days prior to first dose
Radiotherapy to > 25% bone marrow
Major surgery, infection requiring systemic antibiotic therapy within 14 days prior to first dose
Inability to swallow orally administered medication
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
Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853307

Locations

United States, New Jersey
Summit Medical Group
Berkeley Heights, New Jersey, United States, 07922

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

Study Director:

Medical Monitor

Millennium Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00853307 History of Changes
Other Study ID Numbers:	C14006
Study First Received:	February 26, 2009
Last Updated:	March 23, 2012
Health Authority:	United States: Food and Drug Administration France: Afssaps - French Health Products Safety Agency Poland: Ministry of Health

Additional relevant MeSH terms:

Carcinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site

Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 23, 2012