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mTOR Kinase Inhibitor
MLN0128 for Thyroid Cancer
Phase 1 & 2
Waitlist Available
Led By Jochen Lorch, MD. PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up disease was assessed radiologically every 2 cycles/ 8 weeks on treatment until the earliest of first progression, death or 24 months from study entry. relevant for this endpoint was observation at 4-months.
Awards & highlights
Study Summary
This trial is studying a targeted therapy, ML0N128, as a possible treatment for anaplastic thyroid cancer.
Eligible Conditions
- Thyroid Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ disease was assessed radiologically every 2 cycles/ 8 weeks on treatment until the earliest of first progression, death or 24 months from study entry. relevant for this endpoint was observation at 4-months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease was assessed radiologically every 2 cycles/ 8 weeks on treatment until the earliest of first progression, death or 24 months from study entry. relevant for this endpoint was observation at 4-months.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
4-month Progression Free Survival (PFS4) Rate - ATC Cohort [Phase II]
Maximum Tolerated Dose (MTD) [Phase I Dose Escalation]
Number of Participants With Dose Limiting Toxicity (DLT) [Phase I Dose Escalation]
Secondary outcome measures
6-month Progression Free Survival (PFS6) Rate - DTC Cohort [Phase II]
BRAF V600E Status [Phase II]
Clinical Benefit (CBR) by BRAF V600E Status [Phase II]
+3 moreSide effects data
From 2018 Phase 2 trial • 9 Patients • NCT02091531100%
Pain
100%
Fatigue
100%
Rash
89%
Urinary frequency
89%
Dyspnea
78%
Diarrhea
78%
Anorexia
78%
Mucositis
56%
Constipation
44%
Nausea
44%
Edema
33%
Vomiting
22%
Dizziness
11%
Non-cardiac chest pain
11%
Platelet count decreased
11%
Rash maculo-papular
11%
Allergic reaction
11%
Anemia
11%
Buttock Pain
11%
Delirium
11%
Edema limbs
100%
80%
60%
40%
20%
0%
Study treatment Arm
MLN0128
Trial Design
6Treatment groups
Experimental Treatment
Group I: Phase II: DTC CohortExperimental Treatment1 Intervention
Phase II participants receive MLN0128 at the recommended phase II dose of 5 mg orally, daily for 28 days. Participants are treated until disease progression or withdrawal of consent. All phase I participants treated at the maximum tolerated dose/ recommended phase II dose (DL3) are enrolled in the phase II part of the study according to the appropriate disease cohort.
Group II: Phase II: ATC CohortExperimental Treatment1 Intervention
Phase II participants receive MLN0128 at the recommended phase II dose of 5 mg orally, daily for 28 days. Participants are treated until disease progression or withdrawal of consent. All phase I participants treated at the maximum tolerated dose/ recommended phase II dose (DL3) are enrolled in the phase II part of the study according to the appropriate disease cohort.
Group III: Phase I: Dose Level 3 (PI DL3) ExpansionExperimental Treatment1 Intervention
Phase I Dose Level 3 participants receive MLN0128 5 mg orally, daily for 28 days. Participants are treated until disease progression or withdrawal of consent.
Group IV: Phase I: Dose Level 3 (PI DL3)Experimental Treatment1 Intervention
Phase I Dose Level 3 participants receive MLN0128 5 mg orally, daily for 28 days. Participants are treated until disease progression or withdrawal of consent.
Group V: Phase I: Dose Level 2 (PI DL2)Experimental Treatment1 Intervention
Phase I Dose Level 3 (dose escalation) participants received MLN0128 5 mg orally, daily for 28 days. Participants are treated until disease progression or withdrawal of consent.
Group VI: Phase I: Dose Level 1 (PI DL1)Experimental Treatment1 Intervention
Phase I Dose Level 1 participants receive MLN0128 3 mg orally, daily for 28 days. Participants are treated until disease progression or withdrawal of consent.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MLN0128
2016
Completed Phase 2
~600
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,902 Total Patients Enrolled
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,868 Total Patients Enrolled
Jochen Lorch, MD. PhDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have received certain types of blood treatments or medications.You need to have tissue available for additional research studies.You need to have a disease that can be measured.You are able to perform daily activities without help or with some restrictions.You do not have any active cancer that has spread to your brain.You have not fully recovered from the side effects of previous cancer treatments.You have an advanced type of thyroid cancer that can't be treated with surgery, radiation, or chemotherapy alone.You can have received any amount of chemotherapy or targeted drugs in the past, including drugs like rapamycin analogues.Your diabetes is not well controlled.You have trouble absorbing nutrients because of past stomach surgery or illness.You have had a heart attack, stroke, serious heart rhythm problems, or other serious heart conditions in the last 6 months.You have uncontrolled high blood pressure, severe lung or heart disease, or abnormal heart rhythm.Your blood, liver, kidney, and heart need to be working properly. Your blood counts, liver function, kidney function, and heart function need to meet certain levels.
Research Study Groups:
This trial has the following groups:- Group 1: Phase II: ATC Cohort
- Group 2: Phase I: Dose Level 3 (PI DL3) Expansion
- Group 3: Phase II: DTC Cohort
- Group 4: Phase I: Dose Level 3 (PI DL3)
- Group 5: Phase I: Dose Level 2 (PI DL2)
- Group 6: Phase I: Dose Level 1 (PI DL1)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current capacity of the clinical trial for participants?
"Unfortunately, this medical study is not currently recruiting. It was first made available on July 1st 2015 but has since been revised as of February 18th 2022. However, if you are looking for alternative trials to join there are 233 studies searching for individuals with thyroid cancer and 11 that require MLN0128 participants."
Answered by AI
What other experiments have been conducted with MLN0128?
"Currently, 11 studies on the efficacy of MLN0128 are underway with none in Phase 3. Although most trials for this drug are situated in Boston, Massachusetts, there are 1,934 different locations hosting these investigations."
Answered by AI
Are there any current opportunities to join this research endeavor?
"This clinical trial is no longer recruiting patients. It was first posted on July 1st, 2015 and received its final update on February 18th 2022. If you're looking for other trials to participate in, there are presently 233 studies actively seeking people with thyroid cancer or anaplastic and 11 trials specifically searching for MLN0128 participants."
Answered by AI
Has MLN0128 received endorsement from the FDA?
"Due to the lack of evidence supporting MLN0128's efficacy, its safety rating is 2. This assessment is based off Phase 2 trial data which suggests that this medication may be safe but not efficacious."
Answered by AI
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