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Dose Escalation Study of MLN1117 in Subjects With Advanced Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Millennium Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01449370
First received: August 11, 2011
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of MLN1117 when administered orally in subjects with advanced solid malignancies.


Condition Intervention Phase
Metastatic Solid Tumors
Drug: MLN1117
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Dose Escalation Study of MLN1117 in Subjects With Advanced Solid Malignancies Followed by Expansion in Subjects With Measurable Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) [ Time Frame: 3 week cycle ] [ Designated as safety issue: Yes ]
  • Number of Adverse Events (AE) [ Time Frame: From first dose of study drug through 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma level of MLN1117 [ Time Frame: Days 1-21 of Cycles 1 & 2 ] [ Designated as safety issue: No ]
    Pharmacokinetic profile

  • Biomarker levels [ Time Frame: Day 1 of Cycle 2 (Arms B & C only) ] [ Designated as safety issue: No ]
    Pharmacodynamic profile in samplings of skin and/or tumor biopsies pre- and post-treatment.

  • Objective response rate [ Time Frame: Day 1 of Cycles 3 and beyond and at termination visit ] [ Designated as safety issue: No ]
    Complete response and partial response


Estimated Enrollment: 124
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A
MLN1117 administered once a day orally
Drug: MLN1117
oral administration of MLN1117, daily and intermittent schedules.
Experimental: Arm B
MLN1117 administered orally intermittently, once every other day (Monday, Wednesday, and Friday) each week
Drug: MLN1117
oral administration of MLN1117, daily and intermittent schedules.
Experimental: Arm C
MLN1117 administered orally intermittently, once a day for 3 consecutive days (Monday, Tuesday, and Wednesday) each week
Drug: MLN1117
oral administration of MLN1117, daily and intermittent schedules.

  Eligibility

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

Inclusion Criteria:

  • Subjects have had their PIK3CA gene mutation status assessed prior to enrolling into the study
  • Subjects must have documented disease progression prior to enrolling into the study
  • locally advanced or metastatic solid tumors with the exception of primary brain tumor, and have failed or are not eligible for standard of care therapy.
  • Age ≥ 18 years, including males and females;
  • ECOG performance status (PS) 0-1;
  • Adequate organ function;
  • Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
  • Ability to swallow oral medications;
  • Ability to understand and willingness to sign informed consent prior to initiation of any study procedures;
  • For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration

Exclusion Criteria:

  • Diagnosis of primary brain tumor; untreated brain metastasis or history of leptomeningeal disease or spinal cord compression;
  • Received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug;
  • Have received a systemic corticosteroid within one week prior to the first administration of study drug;
  • Clinically significant cardiac disease;
  • Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug;
  • Malabsorption ;
  • Poorly controlled diabetes mellitus;
  • Pregnancy (positive serum or urine pregnancy test) or breast feeding;
  • Untreated brain metastasis or history of leptomeningeal disease or spinal cord compression;
  • Failed to recover from the reversible effects of prior anticancer therapies;
  • Have received a selective PI3K-alpha inhibitor
  • Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system (CNS) disease, active infection, or any other condition that could compromise the subject's participation in the study
  • Known human immunodeficiency virus (HIV) infection
  • Have a secondary malignancy within the last 3 years prior to first dose of study drug, excluding treated non-melanoma skin cancer, carcinoma in situ, or locally-treated prostate cancer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449370

Contacts
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-877-674-3784 medical@mlnm.com

Locations
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Recruiting
Detroit, Michigan, United States, 48201
Spain
Recruiting
Barcelona, Spain
United Kingdom
Recruiting
Sutton, Surrey, United Kingdom
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: NCT01449370     History of Changes
Other Study ID Numbers: INK1117-001
Study First Received: August 11, 2011
Last Updated: January 20, 2014
Health Authority: United States: Food and Drug Administration
Spain: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Millennium Pharmaceuticals, Inc.:
INK1117
PIK3CA
KINASE
TUMOR
CANCER
Locally advanced or metastatic solid tumors
not eligible for standard of care therapy

ClinicalTrials.gov processed this record on November 25, 2014