MLN8237 for Treatment of Participants With Ovarian, Fallopian Tube, or Peritoneal Carcinoma

NCT00853307 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: C140062008-006979-72U1111-1187-6616
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the anti-tumour activity of alisertib (MLN8237) in the treatment of participants with platinum-refractory or platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinomas.

Conditions

Ovarian Carcinoma

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• Combined Best Overall Response Rate Based on Investigator Assessment

  Combined objective response rate is defined as the percentage of participants with Complete Response (CR) + Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1 or response by Cancer antigen (CA) 125 criteria. According to RECIST: CR is defined as disappearance of all target lesions and PR is defined as 30% decrease in the sum of the longest diameter of target lesions. CA 125 response criteria is defined as either: A 50% decrease from 2 initially elevated samples; the sample demonstrating the 50% decrease must have been confirmed by a fourth sample 28 days later (a total of 4 samples required) or A serial decrease of \> 75% over 3 samples; the third sample was to be obtained 28 days after the second (a total of 3 samples required).

  Every 2 cycles up to 12 months until progressive disease (PD); Participants who discontinue study drug before PD: Follow-Up (FU)-every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)

Secondary Outcomes (7)

• Progression Free Survival (PFS)

  Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)

• Duration Of Response (DOR)

  Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)

• Time To Progression (TTP)

  Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)

• Clinical Benefit Rate

  Every 2 cycles up to 12 months until PD; Participants who discontinue study drug before PD: FU - every 12 weeks up to 12 months until PD/other cancer therapy; CA 125 Day 1 of cycle, End of Treatment and FU (Up to 22 Months)

• Number of Participants With Treatment-Emergent Adverse Events and Serious Adverse Events

  First dose to 30 days past last dose (Up to 18.9 Months)

Study Arms (1)

Alisertib 50 mg

EXPERIMENTAL

Alisertib 50 mg, capsules, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 26 Cycles).

Drug: Alisertib

Interventions

Alisertib DRUG

Alisertib capsules

Also known as: MLN8237

Alisertib 50 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants 18 years or older.
• Histologically or cytologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
• Eastern Cooperative Oncology Group (ECOG) 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 Cancer antigen (CA) 125 level of \> 40 units/mL AND clinical evidence disease.

You may not qualify if:

• 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 or 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.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (1)

Summit Medical Group

Berkeley Heights, New Jersey, 07922, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

MLN 8237

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: March 2, 2009
• Study Start: March 23, 2009
• Primary Completion: November 23, 2009
• Study Completion: January 27, 2011
• Last Updated: April 8, 2022
• Results First Posted: March 27, 2018

Record last verified: 2022-04

Locations

US (1)