Trial · NCT02514824
MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma
NCT02514824, Phase 1, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2020-12-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma. Trials, record NCT02514824. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02514824
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma
- NCT number
- NCT02514824
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Merkel Cell Carcinoma
- Interventions
- MLN0128
- First posted
- 2015-08-04
- Last updated
- 2020-12-29
- Results first posted
- 2020-12-29
- Limitations and caveats
- The study did not proceed to phase 2 due to slow accrual and lack of efficacy.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | MLN01283 Maximum Tolerated Dose (MTD) [Phase I] | The observation period for DLT evaluation was the first 28 days (cycle 1) of treatment. | The MLN01283 MTD is determined by the number of participants who experience a dose limiting toxicity (DLT). See subsequent primary outcome measure for the DLT definition. The MTD is defined as the highest dose at which fewer than one-third of patients 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 | Dose Limiting Toxicity (DLT) [Phase I] | The observation period for DLT evaluation was the first 28 days (cycle 1) of treatment. | A DLT was defined as an adverse event (AE) assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications meets any of the following criteria including but not limited to: grade (G) 4-5 AEs, G3 thrombocytopenia, neutropenia, AST, ALT, serum creatinine or total bilirubin 2 to 3 x upper limit normal (ULN), aymptomatic amylase and/or lipase lasting \>7 consecutive days; febrile neutropenia; G3 cardiac, hyperglycemia, mood alteration; G2 pancreatitis; G2 hyperglycemia unresolved within 14 days; G2 mood alteration unresolved in 14 days despite medical treatment; Dose interruption \>21 days due to G2 dematologic; one grade level increase neurotoxicity. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | MLN01283 Maximum Tolerated Dose (MTD) [Phase I] | The observation period for DLT evaluation was the first 28 days (cycle 1) of treatment. | All P1 participants who received at least one dose of the study drug were evaluable for the DLT analysis. Participants who discontinued study treatment prior to end of cycle 1 for reason other than dose-limiting toxicity were replaced. | mg | NUMBER |
| PRIMARY | Dose Limiting Toxicity (DLT) [Phase I] | The observation period for DLT evaluation was the first 28 days (cycle 1) of treatment. | All P1 participants who received at least one dose of the study drug were evaluable for the DLT analysis. Participants who discontinued study treatment prior to end of cycle 1 for reason other than dose-limiting toxicity were replaced. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Number of Participants With Objective Response (OR) [Phase 1] | Assessed on treatment and for this study cohort the longest treatment duration was approximately 4 months in each dose level 1 and 2. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| MLN01283 Maximum Tolerated Dose (MTD) [Phase I] | All Phase 1 Participants | 3 | mg | ||
| Dose Limiting Toxicity (DLT) [Phase I] | Dose Level 1: MLN01283 3 mg (Phase 1) | 0 | Participants | ||
| Dose Limiting Toxicity (DLT) [Phase I] | Dose Level 2: MLN01283 4 mg (Phase 1) | 2 | Participants | ||
| Number of Participants With Objective Response (OR) [Phase 1] | Dose Level 1: MLN01283 3 mg (Phase 1) | 0 | Participants | ||
| Number of Participants With Objective Response (OR) [Phase 1] | Dose Level 2: MLN01283 4 mg (Phase 1) | 0 | Participants |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level 1: MLN01283 3 mg (Phase 1) | 4 | |
| Overall Study | STARTED | Dose Level 2: MLN01283 4 mg (Phase 1) | 5 | |
| Overall Study | STARTED | Dose Level 3: MLN01283 5 mg (Phase 1) | 0 | |
| Overall Study | STARTED | MLN01283 RP2D (Phase 2) | 0 | |
| Overall Study | Evaluable for Dose-limiting Toxicity | Dose Level 1: MLN01283 3 mg (Phase 1) | 3 | |
| Overall Study | Evaluable for Dose-limiting Toxicity | Dose Level 2: MLN01283 4 mg (Phase 1) | 5 | |
| Overall Study | Evaluable for Dose-limiting Toxicity | Dose Level 3: MLN01283 5 mg (Phase 1) | 0 | |
| Overall Study | Evaluable for Dose-limiting Toxicity | MLN01283 RP2D (Phase 2) | 0 | |
| Overall Study | COMPLETED | Dose Level 1: MLN01283 3 mg (Phase 1) | 3 | |
| Overall Study | COMPLETED | Dose Level 2: MLN01283 4 mg (Phase 1) | 4 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events108
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 pain | Gastrointestinal disorders | Dose Level 1: MLN01283 3 mg (Phase 1) | 1 | 4 | |
| other | Abdominal pain | Gastrointestinal disorders | Dose Level 2: MLN01283 4 mg (Phase 1) | 0 | 5 | |
| other | Agitation | Psychiatric disorders | Dose Level 1: MLN01283 3 mg (Phase 1) | 0 | 4 | |
| other | Agitation | Psychiatric disorders | Dose Level 2: MLN01283 4 mg (Phase 1) | 1 | 5 | |
| other | Anorexia | Metabolism and nutrition disorders | Dose Level 1: MLN01283 3 mg (Phase 1) | 1 | 4 | |
| other | Anorexia | Metabolism and nutrition disorders | Dose Level 2: MLN01283 4 mg (Phase 1) | 2 | 5 | |
| other | Bladder spasm | Renal and urinary disorders | Dose Level 1: MLN01283 3 mg (Phase 1) | 0 | 4 | |
| other | Bladder spasm | Renal and urinary disorders | Dose Level 2: MLN01283 4 mg (Phase 1) | 1 | 5 | |
| other | Confusion | Psychiatric disorders | Dose Level 1: MLN01283 3 mg (Phase 1) | 0 | 4 | |
| other | Confusion | Psychiatric disorders | Dose Level 2: MLN01283 4 mg (Phase 1) | 1 | 5 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level 1: MLN01283 3 mg (Phase 1) | 3 | 4 |
| Total, all-cause mortality | Dose Level 2: MLN01283 4 mg (Phase 1) | 3 | 5 |
| Total, other adverse events | Dose Level 1: MLN01283 3 mg (Phase 1) | 4 | 4 |
| Total, other adverse events | Dose Level 2: MLN01283 4 mg (Phase 1) | 5 | 5 |
| Total, serious adverse events | Dose Level 1: MLN01283 3 mg (Phase 1) | 0 | 4 |
| Total, serious adverse events | Dose Level 2: MLN01283 4 mg (Phase 1) | 3 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dose Level 1: MLN01283 3 mg (Phase 1) vs Dose Level 2: MLN01283 4 mg (Phase 1): Number of Participants With Objective Response (OR) [Phase 1] | Trial comparisons |
| Dose Level 1: MLN01283 3 mg (Phase 1) vs Dose Level 2: MLN01283 4 mg (Phase 1): Dose Limiting Toxicity (DLT) [Phase I] | Trial comparisons |
| Dose Level 1: MLN01283 3 mg (Phase 1) vs Dose Level 2: MLN01283 4 mg (Phase 1): deaths from any cause | Trial comparisons |
| Dose Level 1: MLN01283 3 mg (Phase 1) vs Dose Level 2: MLN01283 4 mg (Phase 1): serious adverse events | Trial comparisons |
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/NCT02514824
GET https://conductscience.org/api/trials/v1/NCT02514824/events?page=2