Recent Updates
Recently added Catalysts

TAK-117

Phase 1

Metastatic Solid Tumors | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Last Updated: Mar 9, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment125
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01449370Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced CancerPHASE1 COMPLETED 125Oct 1, 2011Jan 1, 2016Mar 9, 20175 United States, Spain +1
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Maximum Tolerated Dose (MTD) of TAK-117
Baseline up to Cycle 1 Day 21

MTD is highest dose level of TAK-117 at which no more than 1 out of 6 participants had a dose limiting toxicity (DLT) during first cycle. DLT was any 1 of following events occurring within first 21 days of Cycle 1 of TAK-117 administration, Grade 2: fasting hyperglycemia for \>14 days. Grade 3: nausea and/or vomiting/diarrhea for \>7 days; rash for \>7 days; thrombocytopenia with bleeding; fasting hyperglycemia for \>24 hours(hr). Grade \>=3:nonhematologic toxicity considered clinically significant by investigator. Grade 4:neutropenia (absolute neutrophil count \<=0.5\*10\^9per liter\[/L\]) for \>7 days in absence of growth factor support; neutropenia of any duration accompanied with fever \>=38.5 degree Celsius and/or systemic infection. Grade \>=4:hematologic toxicity. Inability to administer at least 75% of planned doses of TAK-117 within Cycle 1 due to its related toxicity;Any clinically significant occurrence that investigators and sponsor agreed would place participants at undue safety risk.

Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Death, Adverse Events (AEs) Leading to Discontinuation of Study Drug, and DLTs in Cycle 1
Baseline up to Cycle 27 Day 45
Number of Participants With Highest Level of TEAEs Severity
Baseline up to Cycle 27 Day 45

Severity of AEs was evaluated based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0 as follow: Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe); Grade 4 (life-threatening); Grade 5 (fatal).

Number of Participants With Clinically Meaningful Changes in Laboratory Values
Baseline up to Cycle 27 Day 45
Number of Participants With Clinically Meaningful Changes in Vital Signs
Baseline up to Cycle 27 day 45
Number of Participants With Clinically Meaningful Changes in Electrocardiogram (ECG)
Baseline up to Cycle 27 Day 45
Secondary Endpoints
Overall Response Rate (ORR)
Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death
Duration of Objective Response
Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death
Clinical Benefit Rate (CBR)
Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTALTAK-117 administered once a day orally
Arm BEXPERIMENTALTAK-117 administered orally intermittently, once every other day (Monday, Wednesday, and Friday) each week
Arm CEXPERIMENTALTAK-117 administered orally intermittently, once a day for 3 consecutive days (Monday, Tuesday, and Wednesday) each week
Interventions
NameTypeDescription
TAK-117DRUGoral administration of TAK-117, daily and intermittent schedules.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

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 hav...

Countries:United StatesSpainUnited Kingdom
Unlock Eligibility Criteria