Trial · NCT02244463
A Phase I/II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer and Incurably Poorly Differentiated or Radioidodine Refractory Differentiated Thyroid Cancer
NCT02244463, Phase 1, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2024-01-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase I/II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer and Incurably Poorly Differentiated or Radioidodine Refractory Differentiated Thyroid Cancer. Trials, record NCT02244463. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02244463
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I/II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer and Incurably Poorly Differentiated or Radioidodine Refractory Differentiated Thyroid Cancer
- NCT number
- NCT02244463
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Anaplastic Thyroid Cancer, Thyroid Cancer, Differentiated Thyroid Cancer
- Interventions
- MLN0128
- First posted
- 2014-09-19
- Last updated
- 2024-01-12
- Results first posted
- 2024-01-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) [Phase I Dose Escalation] | 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). |
| Primary | Number of Participants With Dose Limiting Toxicity (DLT) [Phase I Dose Escalation] | 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. |
| Primary | 4-month Progression Free Survival (PFS4) Rate - ATC Cohort [Phase II] | 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. |
| Secondary | Number of Participants With Grade 3-5 Treatment-related Toxicity [Phase I/Phase II] | 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). | 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. |
| Secondary | 6-month Progression Free Survival (PFS6) Rate - DTC Cohort [Phase II] | 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. | 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. |
| Secondary | Overall Response Rate (ORR) [Phase II] | 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). | 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. |
| Secondary | Median Overall Survival (OS) [Phase II] | Long term follow-up for survival was every 3 months post-treatment end up to 24 months. | OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive. |
| Secondary | BRAF V600E Status [Phase II] | Baseline | Participants were classified by BRAF V600E mutation status evaluated by next generation sequencing (NGS) platforms using tumor tissue collected at baseline. |
| Secondary | Clinical Benefit (CBR) by BRAF V600E Status [Phase II] | 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). | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) [Phase I Dose Escalation] | cycle 1 (cycle duration=28 days) | The analysis datasets reflects participants who enrolled on the phase I dose escalation study. | mg | NUMBER |
| PRIMARY | Number of Participants With Dose Limiting Toxicity (DLT) [Phase I Dose Escalation] | cycle 1 (cycle duration=28 days) | The analysis population is comprised of all participants enrolled in the PI dose escalation design. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | 4-month Progression Free Survival (PFS4) Rate - ATC Cohort [Phase II] | 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. | The analysis dataset is comprised of all participants enrolled to the Phase II ATC cohort. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Grade 3-5 Treatment-related Toxicity [Phase I/Phase II] | 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). | The analysis dataset is comprised of all participants enrolled to the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 6-month Progression Free Survival (PFS6) Rate - DTC Cohort [Phase II] | 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. | The analysis dataset is comprised of all participants enrolled to the Phase II DTC cohort. | percentage of participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) [Phase II] | 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). | The analysis dataset is comprised of all participants enrolled to the Phase II ATC and DTC cohorts. | percentage of participants | NUMBER |
| SECONDARY | Median Overall Survival (OS) [Phase II] | Long term follow-up for survival was every 3 months post-treatment end up to 24 months. | The analysis dataset is comprised of all participants enrolled to the Phase II ATC and DTC cohorts. | months | MEDIAN |
| SECONDARY | BRAF V600E Status [Phase II] | Baseline | The analysis dataset is comprised of participants with evaluable baseline samples. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Benefit (CBR) by BRAF V600E Status [Phase II] | 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). | The analysis dataset is comprised of participants with evaluable baseline samples. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) [Phase I Dose Escalation] | All Phase I Dose Escalation Participants | 5 | mg | ||
| Number of Participants With Dose Limiting Toxicity (DLT) [Phase I Dose Escalation] | Phase I: Dose Level 1 (PI DL1) | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicity (DLT) [Phase I Dose Escalation] | Phase I: Dose Level 2 (PI DL2) | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicity (DLT) [Phase I Dose Escalation] | Phase I: Dose Level 3 (PI DL3) | 0 | Participants | ||
| 4-month Progression Free Survival (PFS4) Rate - ATC Cohort [Phase II] | Phase II: ATC Cohort | 11.1 | 90% Confidence Interval 2.0 to 31.0 | percentage of participants | |
| Number of Participants With Grade 3-5 Treatment-related Toxicity [Phase I/Phase II] | PI DL1 | 0 | Participants | ||
| Number of Participants With Grade 3-5 Treatment-related Toxicity [Phase I/Phase II] | PI DL2 | 1 | Participants | ||
| Number of Participants With Grade 3-5 Treatment-related Toxicity [Phase I/Phase II] | PI DL3 | 0 | Participants | ||
| Number of Participants With Grade 3-5 Treatment-related Toxicity [Phase I/Phase II] | PI DL3 Exp | 3 | Participants | ||
| Number of Participants With Grade 3-5 Treatment-related Toxicity [Phase I/Phase II] | Phase II: ATC Cohort | 4 | Participants |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow90
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1: PI DL1 Dose Escalation | STARTED | Phase I: Dose Level 1 (PI: DL1) | 3 | |
| Period 1: PI DL1 Dose Escalation | STARTED | Phase I: Dose Level 2 (PI: DL2) | 0 | |
| Period 1: PI DL1 Dose Escalation | STARTED | Phase I: Dose Level 3 (PI: DL3) | 0 | |
| Period 1: PI DL1 Dose Escalation | STARTED | Phase I: Dose Level 3 Expansion (PI: DL3 Exp) | 0 | |
| Period 1: PI DL1 Dose Escalation | STARTED | Phase II: ATC Cohort | 0 | |
| Period 1: PI DL1 Dose Escalation | STARTED | Phase II: DTC Cohort | 0 | |
| Period 1: PI DL1 Dose Escalation | COMPLETED | Phase I: Dose Level 1 (PI: DL1) | 0 | |
| Period 1: PI DL1 Dose Escalation | COMPLETED | Phase I: Dose Level 2 (PI: DL2) | 0 | |
| Period 1: PI DL1 Dose Escalation | COMPLETED | Phase I: Dose Level 3 (PI: DL3) | 0 | |
| Period 1: PI DL1 Dose Escalation | COMPLETED | Phase I: Dose Level 3 Expansion (PI: DL3 Exp) | 0 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 participant flowAdverse events1,200
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | PI: DL1 | 0 | 3 | |
| other | Abdominal distension | Gastrointestinal disorders | PI: DL2 | 0 | 3 | |
| other | Abdominal distension | Gastrointestinal disorders | PI: DL3 | 1 | 3 | |
| other | Abdominal distension | Gastrointestinal disorders | PI: DL3 Exp | 0 | 10 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase II: ATC Cohort | 0 | 12 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase II: DTC Cohort | 0 | 15 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase II: ATC Cohort (Including P1 DL3) | 0 | 18 | |
| other | Abdominal distension | Gastrointestinal disorders | Phase II: DTC Cohort (Including P1 DL3) | 1 | 22 | |
| other | Abdominal pain | Gastrointestinal disorders | PI: DL1 | 2 | 3 | |
| other | Abdominal pain | Gastrointestinal disorders | PI: DL2 | 0 | 3 |
1 to 10 of 1,200Source ClinicalTrials.gov
See all 1,200 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PI: DL1 | 0 | 3 |
| Total, all-cause mortality | PI: DL2 | 1 | 3 |
| Total, all-cause mortality | PI: DL3 | 0 | 3 |
| Total, all-cause mortality | PI: DL3 Exp | 0 | 10 |
| Total, all-cause mortality | Phase II: ATC Cohort | 0 | 12 |
| Total, all-cause mortality | Phase II: DTC Cohort | 0 | 15 |
| Total, all-cause mortality | Phase II: ATC Cohort (Including P1 DL3) | 0 | 18 |
| Total, all-cause mortality | Phase II: DTC Cohort (Including P1 DL3) | 0 | 22 |
| Total, other adverse events | PI: DL1 | 3 | 3 |
| Total, other adverse events | PI: DL2 | 3 | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27240885 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02244463
GET https://conductscience.org/api/trials/v1/NCT02244463/results?page=2