Metastatic Solid TumorsPhase 1NCT01449370
Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer
A Phase 1 study testing TAK-117 in people with Metastatic Solid Tumors, run by Millennium Pharmaceuticals, Inc. at 5 sites in 3 countries.
Trial 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 TAK-117 when administered orally in subjects with advanced solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Solid Tumors
- What is being tested?
- TAK-117
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Oct 2011to Jan 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 greater than or equal to (>=) 18 years, including males and females;
- Eastern cooperative oncology group (ECOG) performance status (PS) 0-1;
- Adequate organ function;
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- 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
Who cannot join
- 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 ;
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- 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 phosphoinositide-3-kinase alpha isoform (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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States3 sites
Study site
Boston, Massachusetts
Study site
Dallas, Texas
Study site
Detroit, Michigan
About this study
Official title: A Phase I, Dose Escalation Study of MLN1117 in Subjects With Advanced Solid Malignancies Followed by Expansion in Subjects With Measurable Disease
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 TAK-117 when administered orally in subjects with advanced solid malignancies.
- Conditions
- Metastatic Solid Tumors
- Being tested
- TAK-117
- Keywords
- INK1117, PIK3CA, KINASE, TUMOR, CANCER, Locally advanced or metastatic solid tumors, not eligible for standard of care therapy
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-117Drug
oral administration of TAK-117, daily and intermittent schedules.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | TAK-117 administered once a day orally Receives: Drug: TAK-117 |
| Arm B | Experimental | TAK-117 administered orally intermittently, once every other day (Monday, Wednesday, and Friday) each week Receives: Drug: TAK-117 |
| Arm C | Experimental | TAK-117 administered orally intermittently, once a day for 3 consecutive days (Monday, Tuesday, and Wednesday) each week Receives: Drug: TAK-117 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of TAK-117
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.
Measured: Baseline up to Cycle 1 Day 21
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
Measured: Baseline up to Cycle 27 Day 45
Number of Participants With Highest Level of TEAEs Severity
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).
Measured: Baseline up to Cycle 27 Day 45
Number of Participants With Clinically Meaningful Changes in Laboratory Values
Measured: Baseline up to Cycle 27 Day 45
Number of Participants With Clinically Meaningful Changes in Vital Signs
Measured: Baseline up to Cycle 27 day 45
Number of Participants With Clinically Meaningful Changes in Electrocardiogram (ECG)
Measured: Baseline up to Cycle 27 Day 45
Secondary outcomes (11)
Overall Response Rate (ORR)
The estimate of the ORR is calculated as crude percentage of participants who's best overall response is complete response (CR) or partial response (PR). Objective response (CR and PR) as determined by the participants best tumor response was assessed using response evaluation criteria in solid tumors (RECIST) version 1.1. As per RECIST version 1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 millimeter [mm]). No new lesions. PR was defined as >=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. Stable disease was defined as not qualifying for CR, PR, and progressive disease (PD).
Measured: Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death
Duration of Objective Response
Duration of response was to be calculated for participants who achieved CR or PR. Duration of objective response was defined as the number of days from the start date of PR or CR (whichever response was achieved first) to the first date that PD or disease progression was objectively documented. The duration of objective response was to be right-censored for participants who achieved CR or PR and met 1 of the following conditions: Non-protocol anticancer treatment started before documentation of PD; Documented PD after more than 1 missed disease assessment visit; Alive and did not have documentation of PD before a data analysis cutoff date.
Measured: Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death
Clinical Benefit Rate (CBR)
Clinical benefit rate was defined as the participants who achieved stable disease (SD) for at least 15 weeks, CR, or PR. The estimate of the CBR was calculated as crude percentage of participants whose best ORR was CR, PR or SD for at least 90 days.
Measured: Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death
Cmax: Maximum Observed Plasma Concentration for TAK-117
Measured: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
Ctrough: Observed Concentration at the End of Dosing Interval for TAK-117
Measured: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117
Measured: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
T 1/2z: Terminal Disposition Phase Half-life for TAK-117
Measured: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117
Measured: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117
Measured: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
%AUC Extrapolated: Percentage of Area Under Concentration-extrapolated
Measured: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
Percent Change From Baseline in Pharmacodynamic Markers
Pharmacodynamic markers included phosphorylated ribosomal protein S6 (PS6), phosphorylated eukaryotic initiation factor 4E-binding protein 1 (P4EBP1), phosphorylated N-myc downstream regulated gene 1 (PNDRG1), phosphorylated proline-rich AKT substrate of 40 kilodaltons (PPRAS40), and phosphorylated serine/threonine protein kinase AKT (PAKT). Analysis population (n) for each skin biopsy biomarker is as follow: P4EBP1 (n=6,6,6,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PAKT and PNDRG1 (n=6,6,7,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PPRAS40 (n= 6,0,6,2,2,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PS6 (n=6,6,7,2,2,0,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0)."n" for each tumor tissue biomarkers is as follow: P4EBP1, PAKT, PNDRG1, and PS6 (n=1,1,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0); PPRAS40 (n= 1,0,0,0,1,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0,0).
Measured: Cycle 1 Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449370
- Sponsor's protocol ID
- INK1117-001
- Status last verified
- Jan 2017
- First submitted
- 11 Aug 2011
- Last updated
- 9 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Dose Escalation Study of MLN1117 in Subjects With Advanced Solid Malignancies Followed by Expansion in Subjects With Measurable Disease
- ClinicalTrials.gov ID
- NCT01449370
- Acronym / sponsor ID
- INK1117-001
- Conditions
- Metastatic Solid Tumors
- Keywords
- INK1117, PIK3CA, KINASE, TUMOR, CANCER, Locally advanced or metastatic solid tumors, not eligible for standard of care therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Oct 2011 (estimated)
- Results
- Posted 9 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 TAK-117 when administered orally in subjects with advanced solid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: TAK-117TAK-117 administered once a day orally |
| Arm B | Experimental | Drug: TAK-117TAK-117 administered orally intermittently, once every other day (Monday, Wednesday, and Friday) each week |
| Arm C | Experimental | Drug: TAK-117TAK-117 administered orally intermittently, once a day for 3 consecutive days (Monday, Tuesday, and Wednesday) each week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 greater than or equal to (>=) 18 years, including males and females;
- Eastern cooperative oncology group (ECOG) performance status (PS) 0-1;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-117oral administration of TAK-117, daily and intermittent schedules. | Drug | Arm A, Arm B, Arm C |
Primary outcome
Maximum Tolerated Dose (MTD) of TAK-117
Time frame: 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
Time frame: Baseline up to Cycle 27 Day 45
Number of Participants With Highest Level of TEAEs Severity
Time frame: 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
Time frame: Baseline up to Cycle 27 Day 45
Number of Participants With Clinically Meaningful Changes in Vital Signs
Time frame: Baseline up to Cycle 27 day 45
Number of Participants With Clinically Meaningful Changes in Electrocardiogram (ECG)
Time frame: Baseline up to Cycle 27 Day 45
11 secondary outcomes
Overall Response Rate (ORR)
Time frame: Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death
Duration of Objective Response
Time frame: Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death
Clinical Benefit Rate (CBR)
Time frame: Cycle 1 Day 8 up to Cycle 27 Day 1 or disease progression or death
Cmax: Maximum Observed Plasma Concentration for TAK-117
Time frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
Ctrough: Observed Concentration at the End of Dosing Interval for TAK-117
Time frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-117
Time frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
T 1/2z: Terminal Disposition Phase Half-life for TAK-117
Time frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-117
Time frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-117
Time frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
%AUC Extrapolated: Percentage of Area Under Concentration-extrapolated
Time frame: Process A: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 24 hrs) post-dose; Process B: Cycle 1 Day 1 pre-dose and at multiple timepoints (up to 48 hrs) post-dose
Percent Change From Baseline in Pharmacodynamic Markers
Time frame: Cycle 1 Day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Millennium Pharmaceuticals, Inc.
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-117 in people with Metastatic Solid Tumors, run by Millennium Pharmaceuticals, Inc. at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of TAK-117 (time frame: Baseline up to Cycle 1 Day 21). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2017.