Anaplastic Thyroid CancerPhase 1/2NCT02244463
A Phase I/II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer and Incurably Poorly Differentiated or Radioidodine Refractory Differentiated Thyroid Cancer
A Phase 1/2 study testing MLN0128 in people with Anaplastic Thyroid Cancer and Thyroid Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
This research study is a phase I/II study of MLN0128 in metastatic anaplastic thyroid cancer(ATC) and incurably poorly differentiated or radioidodine refractory differentiated thyroid cancer (DTC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaplastic Thyroid Cancer, Thyroid Cancer, Differentiated Thyroid Cancer
- What is being tested?
- MLN0128
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2015to 28 Apr 2022
- Phase
- Phase 1/2
- 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
- Male or female patients 18 years or older
- Any number of prior chemotherapy or targeted agents including rapamycin analogues allowed
- Newly diagnosed or refractory/metastatic anaplastic thyroid cancer confirmed by histology, incurable by surgery, radiotherapy or chemoradiotherapy alone or in combination
- Must have measurable disease
- ECOG performance status 0-2
- No active intracranial metastases
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- Tissue for correlative studies must be available
- Ability to swallow oral medications
- Voluntary written consent must be given before performance of any study related procedure
- Adequate organ function, as specified below, within 21 days:
- Bone marrow reserve consistent with: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; platelet count ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL;
- Hepatic: total bilirubin ≤1.5 x upper limit of normal (ULN), transaminases (aspartate aminotransferase/serum glutamic oxaloacetic transaminase-AST/SGOT and alanine aminotransferase/serum glutamic pyruvic transaminase-ALT/SGPT) ≤2.5 x ULN (≤5 x ULN if liver metastases are present);
- Renal: creatinine clearance ≥50 mL/min
- Metabolic: fasting serum glucose (≤ 130 mg/dL) and fasting triglycerides ≤ 300 mg/dL
- Left ventricular ejection fraction (LVEF) within 5 absolute percentage points of institutional standard of normal as measured by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) within 4 weeks prior to first study drug administration (ie, if the institutional normal is 50%, subject's LVEF may be as low as 45% to be eligible for the study)
- Female patients who:
- Are postmenopausal for at least 1 year before the screening visit, OR
- Are surgically sterile, OR
- If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 90 days after the last dose of study drug, or agree to completely abstain from heterosexual intercourse
- Male patients, even if surgically sterilized (ie, status post-vasectomy), who:
- Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, or
- Agree to completely abstain from heterosexual intercourse
- Treatment with strong CYP2C19, CYP3A4, and CYP2C9 inhibitors and/or inducers must be discontinued
Who cannot join
- Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
- Treatment with any investigational products within 14 days
- Failed to recover from the reversible effects of prior anticancer therapies
- Manifestations of malabsorption due to prior gastrointestinal surgery or disease
- Poorly controlled diabetes mellitus
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- History of any of the following within the last 6 months prior to study entry:
- Ischemic myocardial event
- Ischemic cerebrovascular event
- Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia
- Placement of a pacemaker for control of rhythm
- New York Heart Association Class III or IV heart failure
- Pulmonary embolism
- Significant active cardiovascular or pulmonary disease at the time of study entry, including:
- Uncontrolled high blood pressure
- Pulmonary hypertension
- Uncontrolled asthma or O2 saturation < 90%
- Significant valvular disease
- Medically significant (symptomatic) bradycardia
- History of arrhythmia requiring an implantable cardiac defibrillator
- Baseline prolongation of the rate-corrected QT interval (QTc)
- Treatment with hematopoietic growth factors, transfusions of blood and blood products, or systemic corticosteroids
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan Medical School
Ann Arbor, Michigan, 48109
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
About this study
This research study is a phase I/II study of MLN0128 in metastatic anaplastic thyroid cancer(ATC) and incurably poorly differentiated or radioidodine refractory differentiated thyroid cancer (DTC).
Due to changes in the manufacturing process which resulted in increased absorption of MLN0128 from capsules, a run-in phase I prior to the phase II of the study was needed.
Read more
Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved MLN0128 as a treatment for any disease.
MLN0128 prevents tumor cells from dividing and growing by selectively and potently inhibiting a chemical, mTOR kinase, which regulates cell growth and survival. Patients with anaplastic thyroid cancer have been observed to sometimes carry genetic alterations in their tumor cells which may make the cancer more sensitive to inhibition by MLN0128.
Given the activity with everolimus in RAI refractory thyroid cancer, subjects wth metastatic, incurable differentiated RAI refractory and poorly differentiated thyroid cancer were included.
Read the detailed description
Patients who fulfill eligibility criteria will be entered into the trial to receive MLN0128.
- Being tested
- MLN0128
- Keywords
- Anaplastic Thyroid Cancer, Thyroid Cancer, Differentiated Thyroid Cancer
- Medical subject headings
- Thyroid Carcinoma, Anaplastic, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MLN0128Drug
Also called INK128, Sapanisertib
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Dose Level 1 (PI DL1) | Experimental | 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. Receives: Drug: MLN0128 |
| Phase I: Dose Level 2 (PI DL2) | Experimental | 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. Receives: Drug: MLN0128 |
| Phase I: Dose Level 3 (PI DL3) | Experimental | 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. Receives: Drug: MLN0128 |
| Phase I: Dose Level 3 (PI DL3) Expansion | Experimental | 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. Receives: Drug: MLN0128 |
| Phase II: ATC Cohort | Experimental | 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. Receives: Drug: MLN0128 |
| Phase II: DTC Cohort | Experimental | 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. Receives: Drug: MLN0128 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) [Phase I Dose Escalation]
The MTD is determined by the number of participants who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of participants experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D).
Measured: cycle 1 (cycle duration=28 days)
Number of Participants With Dose Limiting Toxicity (DLT) [Phase I Dose Escalation]
DLT is defined as an adverse event based on the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications, that meets any of the criteria (hematologic, renal, hepatic, endocrine, metabolic/laboratory, pancreatitis, cardiac, neurotoxicity, mood alteration, dermatologic] listed in section 5.3.2 of the protocol.
Measured: cycle 1 (cycle duration=28 days)
4-month Progression Free Survival (PFS4) Rate - ATC Cohort [Phase II]
PFS4 rate is the percentage of participants remaining alive and progression-free at 4-months from study entry. Per RECIST 1.1 for target lesions: disease progression (PD) is at least a 20% increase in sum longest diameter (LD), taking as reference the smallest sum on study with at least 5 mm absolute increase or the appearance of one or more new lesions. For non-target lesions, PD is appearance of one or more new lesions or unequivocal progression of existing non-target lesions.
Measured: 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.
Secondary outcomes (6)
Number of Participants With Grade 3-5 Treatment-related Toxicity [Phase I/Phase II]
All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Maximum grade toxicity by AE type was then calculated. Incidence is the number of participants experiencing at least one grade 2-5 treatment-related AE during the time of observation.
Measured: Assessed on treatment at cycles 1 and 2 (days 1 and 15), cycle 3+ on day 1, at the end of treatment and up to 30 days post-treatment. Participants were on treatment up to 21.6 months (median 2.1 months).
6-month Progression Free Survival (PFS6) Rate - DTC Cohort [Phase II]
PFS6 rate is the percentage of patients remaining alive and progression-free at 6-months from study entry. Per RECIST 1.1 for target lesions: disease progression (PD) is at least a 20% increase in sum longest diameter (LD), taking as reference the smallest sum on study with at least 5 mm absolute increase or the appearance of one or more new lesions. For non-target lesions, PD is appearance of one or more new lesions or unequivocal progression of existing non-target lesions.
Measured: 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 6-months.
Overall Response Rate (ORR) [Phase II]
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Confirmatory scan obtained 8 weeks following initial documentation of objective response.
Measured: Disease was assessed radiologically every 2 cycles/ 8 weeks on treatment until the earliest of first progression, death or 24 months from study entry. Participants were on treatment up to 196 days (PII ATC) and 454 days (PII DTC).
Median Overall Survival (OS) [Phase II]
OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.
Measured: Long term follow-up for survival was every 3 months post-treatment end up to 24 months.
BRAF V600E Status [Phase II]
Participants were classified by BRAF V600E mutation status evaluated by next generation sequencing (NGS) platforms using tumor tissue collected at baseline.
Measured: Baseline
Clinical Benefit (CBR) by BRAF V600E Status [Phase II]
CBR was defined as the percentage of participants achieving complete response (CR), partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions; PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. Confirmatory scan obtained 8 weeks following initial documentation of CR or PR. SD is neither PR or better nor PD (defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum since treatment start, or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions). Participants were classified by BRAF V600E status based on established methods using tumor tissue collected at baseline.
Measured: BRAF V600E status per NGS at baseline. Disease response was assessed every 2 cycles on treatment until the first progression, death or 24 months from study entry. Participants were on treatment up to 196 days (PII ATC) and 454 days (PII DTC).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startJul 2015
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anaplastic Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Kartik Sehgal, MD, Dana-Farber Cancer Institute
- Investigators
- Kartik Seghal, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244463
- Sponsor's protocol ID
- 14-223
- Status last verified
- Dec 2023
- First submitted
- 17 Sep 2014
- Last updated
- 12 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: There are no plans to share individual participant data. Cumulative results will be posted here and published.
Publications
Cabanillas ME, McFadden DG, Durante C. Thyroid cancer. Lancet. 2016 Dec 3;388(10061):2783-2795. doi: 10.1016/S0140-6736(16)30172-6. Epub 2016 May 27.
PubMed 27240885
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer and Incurably Poorly Differentiated or Radioidodine Refractory Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT02244463
- Acronym / sponsor ID
- 14-223
- Keywords
- Anaplastic Thyroid Cancer, Thyroid Cancer, Differentiated Thyroid Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Jul 2015 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Posted 12 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is a phase I/II study of MLN0128 in metastatic anaplastic thyroid cancer(ATC) and incurably poorly differentiated or radioidodine refractory differentiated thyroid cancer (DTC).
Due to changes in the manufacturing process which resulted in increased absorption of MLN0128 from capsules, a run-in phase I prior to the phase II of the study was needed.
Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved MLN0128 as a treatment for any disease.
MLN0128 prevents tumor cells from dividing and growing by selectively and potently inhibiting a chemical, mTOR kinase, which regulates cell growth and survival. Patients with anaplastic thyroid cancer have been observed to sometimes carry genetic alterations in their tumor cells which may make the cancer more sensitive to inhibition by MLN0128.
Given the activity with everolimus in RAI refractory thyroid cancer, subjects wth metastatic, incurable differentiated RAI refractory and poorly differentiated thyroid cancer were included.
Detailed description
Patients who fulfill eligibility criteria will be entered into the trial to receive MLN0128.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase I: Dose Level 1 (PI DL1) | Experimental | Drug: MLN0128Phase I Dose Level 1 participants receive MLN0128 3 mg orally, daily for 28 days. Participants are treated until disease progression or withdrawal of consent. |
| Phase I: Dose Level 2 (PI DL2) | Experimental | Drug: MLN0128Phase 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. |
| Phase I: Dose Level 3 (PI DL3) | Experimental | Drug: MLN0128Phase I Dose Level 3 participants receive MLN0128 5 mg orally, daily for 28 days. Participants are treated until disease progression or withdrawal of consent. |
| Phase I: Dose Level 3 (PI DL3) Expansion | Experimental | Drug: MLN0128Phase I Dose Level 3 participants receive MLN0128 5 mg orally, daily for 28 days. Participants are treated until disease progression or withdrawal of consent. |
| Phase II: ATC Cohort | Experimental | Drug: MLN0128Phase 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. |
| Phase II: DTC Cohort | Experimental | Drug: MLN0128Phase 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or female patients 18 years or older
- Any number of prior chemotherapy or targeted agents including rapamycin analogues allowed
- Newly diagnosed or refractory/metastatic anaplastic thyroid cancer confirmed by histology, incurable by surgery, radiotherapy or chemoradiotherapy alone or in combination
- Must have measurable disease
- ECOG performance status 0-2
Key exclusion criteria (22 listed)
- Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
- Treatment with any investigational products within 14 days
- Failed to recover from the reversible effects of prior anticancer therapies
- Manifestations of malabsorption due to prior gastrointestinal surgery or disease
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 |
|---|---|---|
| MLN0128Also: INK128, Sapanisertib | Drug | Phase I: Dose Level 1 (PI DL1), Phase I: Dose Level 2 (PI DL2), Phase I: Dose Level 3 (PI DL3), Phase I: Dose Level 3 (PI DL3) Expansion, Phase II: ATC Cohort, Phase II: DTC Cohort |
Primary outcome
Maximum Tolerated Dose (MTD) [Phase I Dose Escalation]
Time frame: cycle 1 (cycle duration=28 days)
The MTD is determined by the number of participants who experience a dose limiting toxicity (DLT). The MTD is defined as the highest dose at which fewer than one-third of participants experience a DLT. If no DLTs are observed, the MTD is not reached but the highest dose received may be the Recommended Phase II Dose (RP2D).
Number of Participants With Dose Limiting Toxicity (DLT) [Phase I Dose Escalation]
Time frame: cycle 1 (cycle duration=28 days)
DLT is defined as an adverse event based on the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0) or abnormal laboratory value assessed as unrelated to disease, disease progression, intercurrent illness, or concomitant medications, that meets any of the criteria (hematologic, renal, hepatic, endocrine, metabolic/laboratory, pancreatitis, cardiac, neurotoxicity, mood alteration, dermatologic] listed in section 5.3.2 of the protocol.
4-month Progression Free Survival (PFS4) Rate - ATC Cohort [Phase II]
Time frame: 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.
PFS4 rate is the percentage of participants remaining alive and progression-free at 4-months from study entry. Per RECIST 1.1 for target lesions: disease progression (PD) is at least a 20% increase in sum longest diameter (LD), taking as reference the smallest sum on study with at least 5 mm absolute increase or the appearance of one or more new lesions. For non-target lesions, PD is appearance of one or more new lesions or unequivocal progression of existing non-target lesions.
6 secondary outcomes
Number of Participants With Grade 3-5 Treatment-related Toxicity [Phase I/Phase II]
Time frame: Assessed on treatment at cycles 1 and 2 (days 1 and 15), cycle 3+ on day 1, at the end of treatment and up to 30 days post-treatment. Participants were on treatment up to 21.6 months (median 2.1 months).
6-month Progression Free Survival (PFS6) Rate - DTC Cohort [Phase II]
Time frame: 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 6-months.
Overall Response Rate (ORR) [Phase II]
Time frame: Disease was assessed radiologically every 2 cycles/ 8 weeks on treatment until the earliest of first progression, death or 24 months from study entry. Participants were on treatment up to 196 days (PII ATC) and 454 days (PII DTC).
Median Overall Survival (OS) [Phase II]
Time frame: Long term follow-up for survival was every 3 months post-treatment end up to 24 months.
BRAF V600E Status [Phase II]
Time frame: Baseline
Clinical Benefit (CBR) by BRAF V600E Status [Phase II]
Time frame: BRAF V600E status per NGS at baseline. Disease response was assessed every 2 cycles on treatment until the first progression, death or 24 months from study entry. Participants were on treatment up to 196 days (PII ATC) and 454 days (PII DTC).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27240885Cabanillas ME, McFadden DG, Durante C. Thyroid cancer. Lancet. 2016 Dec 3;388(10061):2783-2795. doi: 10.1016/S0140-6736(16)30172-6. Epub 2016 May 27.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data. Cumulative results will be posted here and published.
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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.
Kartik Seghal, MD principal investigator
Dana-Farber Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MLN0128 in people with Anaplastic Thyroid Cancer and Thyroid Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.
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 23 inclusion and 22 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 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 12 Jan 2024). 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) [Phase I Dose Escalation] (time frame: cycle 1 (cycle duration=28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02244463, which also lists 1 linked publication.
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 12 Jan 2024.