Overview

This trial has been completed.

Condition metastatic solid tumors
Treatment mln1117
Phase phase 1
Target PI3K
Sponsor Millennium Pharmaceuticals, Inc.
Start date October 2011
End date July 2015
Trial size 124 participants
Trial identifier NCT01449370, INK1117-001

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
MLN1117 administered once a day orally
mln1117
oral administration of MLN1117, daily and intermittent schedules.
(Experimental)
MLN1117 administered orally intermittently, once every other day (Monday, Wednesday, and Friday) each week
mln1117
oral administration of MLN1117, daily and intermittent schedules.
(Experimental)
MLN1117 administered orally intermittently, once a day for 3 consecutive days (Monday, Tuesday, and Wednesday) each week
mln1117
oral administration of MLN1117, daily and intermittent schedules.

Primary Outcomes

Measure
Maximum Tolerated Dose (MTD)
time frame: 3 week cycle
Number of Adverse Events (AE)
time frame: From first dose of study drug through 30 days after last dose of study drug

Secondary Outcomes

Measure
Plasma level of MLN1117
time frame: Days 1-21 of Cycles 1 & 2
Biomarker levels
time frame: Day 1 of Cycle 2 (Arms B & C only)
Objective response rate
time frame: Day 1 of Cycles 3 and beyond and at termination visit

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase I, Dose Escalation Study of MLN1117 in Subjects With Advanced Solid Malignancies Followed by Expansion in Subjects With Measurable Disease
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Takeda.