Trial · NCT01425008
Study of MLN2480 in Participants With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Participants With Metastatic Melanoma
NCT01425008, Phase 1, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2020-08-10
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ConductScience Library. Study of MLN2480 in Participants With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Participants With Metastatic Melanoma. Trials, record NCT01425008. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01425008
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of MLN2480 in Participants With Relapsed or Refractory Solid Tumors Followed by a Dose Expansion in Participants With Metastatic Melanoma
- NCT number
- NCT01425008
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 149 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Melanoma, Metastatic Melanoma, Solid Tumor, Neoplasm
- Interventions
- MLN2480
- First posted
- 2011-08-29
- Last updated
- 2020-08-10
- Other registries' IDs
- eudract:2012-003397-16
- Results first posted
- 2020-08-10
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | Baseline up to 30 days after last dose, or start of subsequent therapy, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle=22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle=28 days] in Expansion Phase) | |
| Primary | Dose Escalation Phase: Number of Participants With Dose-limiting Adverse Events (AEs) | Cycle 1 (Cycle length= 22 days [Q2D] and 28 days [QW]) | Dose limiting AEs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Dose limiting AEs were defined as any of the following events: Grade 4 neutropenia for more than 7 days under maximum supportive therapy; febrile neutropenia; platelet counts decreased of Grade 3 requiring platelet transfusion or blood platelet decreased of Grade 4; if Course 2 was not initiated within 14 days due to AE related to the protocol treatment; Grade 3 or higher non-hematologic toxicity that was considered clinically significant, except the following cases, Grade 3 gastrointestinal symptoms that could be controlled with supportive therapy (example, appropriate use of antiemetics, antidiarrheals), and Grade 3 or higher electrolyte abnormalities that were not deemed clinically significant. |
| Primary | Number of Participants With TEAEs Related to Physical Examination Findings | Baseline up to 30 days after last dose, or start of subsequent therapy, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle=22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle=28 days] in Expansion Phase) | |
| Primary | Clinically Significant Change From Baseline in Body Weight at End of Study Visit (EOSV) | Baseline up to EOSV (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle length =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle length =28 days] in Expansion Phase) | |
| Primary | Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings | Baseline up to 30 days after last dose, or start of subsequent therapy, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle=22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle=28 days] in Expansion Phase) | |
| Primary | Eastern Cooperative Oncology Group (ECOG) Performance Score | at EOSV (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle length =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle length =28 days] in Expansion Phase) | ECOG performance score was measured on 6 point scale to assess participant's performance status, where: 0 (fully active, able to carry on all pre-disease activities without restriction); 1 (restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work); 2 (ambulatory greater than(\>) 50 percent (%) of waking hours), capable of all self-care, unable to carry out any work activities); 3 (capable of only limited self-care, confined to bed or chair \>50% of waking hours); 4(completely disabled, cannot carry on any self-care, totally confined to bed or chair); 5 (dead). A higher score indicated greater functional impairment. |
| Primary | Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis | Baseline up to 30 days after last dose, or start of subsequent therapy, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle=22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle=28 days] in Expansion Phase) | |
| Secondary | Overall Response Rate (ORR) | Baseline up to EOSV (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle length =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle length =28 days] in Expansion Phase) | ORR was defined as the percentage of participants with complete response (CR) or partial response (PR). The ORR assessment was based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (\<) 10 millimeter (mm). PR: was at least a 30% decrease in sum of diameter (SOD) of target lesions, taking as reference the baseline SOD. |
| Secondary | Progression-free Survival (PFS) | Baseline up to the date of first document PD, or death due to any cause, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle =28 days] in Expansion Phase) | PFS was the time from first dose date of study drug to date of the first documentation of confirmed progressive disease (PD) or death, whichever occurred first. The PFS assessment was based on RECIST 1.1. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions. PFS was calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval. Participants with no response assessment were censored at the date of first dose. |
| Secondary | Duration of Response (DOR) | From the first documented response (CR or PR) up to the date of first documented PD (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle =28 days] in Expansion Phase) | DOR was assessed from the first documented response (CR or PR) to the date of first documented PD and was censored at the date of the last assessment for responders who died without documented PD and for responders who were still alive and had not progressed. DOR assessment was based on RECIST v1.1. CR: was disappearance of all target lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD persistence of one or more non-target lesions and/or maintenance of tumor marker level above the normal limits. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. DOR was calculated using Kaplan-Meier estimate. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | Baseline up to 30 days after last dose, or start of subsequent therapy, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle=22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle=28 days] in Expansion Phase) | The safety population included all participants who received at least 1 dose of study drug (TAK-580). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Dose Escalation Phase: Number of Participants With Dose-limiting Adverse Events (AEs) | Cycle 1 (Cycle length= 22 days [Q2D] and 28 days [QW]) | The safety population included all participants who received at least 1 dose of study drug (TAK-580). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With TEAEs Related to Physical Examination Findings | Baseline up to 30 days after last dose, or start of subsequent therapy, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle=22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle=28 days] in Expansion Phase) | The safety population included all participants who received at least 1 dose of study drug (TAK-580). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Clinically Significant Change From Baseline in Body Weight at End of Study Visit (EOSV) | Baseline up to EOSV (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle length =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle length =28 days] in Expansion Phase) | The safety population included all participants who received at least 1 dose of study drug (TAK-580). Participants who were evaluable for this measure at given time point were included for the assessment. | kilogram (kg) | MEAN |
| PRIMARY | Number of Participants With Abnormal Clinically Significant Electrocardiogram (ECG) Findings | Baseline up to 30 days after last dose, or start of subsequent therapy, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle=22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle=28 days] in Expansion Phase) | The safety population included all participants who received at least 1 dose of study drug (TAK-580). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Eastern Cooperative Oncology Group (ECOG) Performance Score | at EOSV (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle length =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle length =28 days] in Expansion Phase) | The safety population included all participants who received at least 1 dose of study drug (TAK-580). Participants who were evaluable for this measure at given time point were included for the assessment. | score on a scale | MEAN |
| PRIMARY | Number of Participants With TEAEs Categorized Into Investigations Related to Laboratory Test of Chemistry, Hematology or Urinalysis | Baseline up to 30 days after last dose, or start of subsequent therapy, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle=22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle=28 days] in Expansion Phase) | The safety population included all participants who received at least 1 dose of study drug (TAK-580). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) | Baseline up to EOSV (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle length =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle length =28 days] in Expansion Phase) | Response-evaluable population included all participants with measurable disease who received any amount of TAK-580 and had at least 1 postbaseline response assessment. | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Baseline up to the date of first document PD, or death due to any cause, whichever occurred first (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle =28 days] in Expansion Phase) | The safety population included all participants who received at least 1 dose of study drug (TAK-580). | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From the first documented response (CR or PR) up to the date of first documented PD (up to Cycle 38 Days 52 [Q2D] and 58 [QW] [Cycle =22 days (Q2D) and 28 days (QW)] in Escalation Phase; Cycle 49 Day 58 [Cycle =28 days] in Expansion Phase) | Analysis population included only a subset of participants (all responders) with response. | months | MEDIAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group604
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle) | TEAEs | 4 | Participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle) | TEAEs | 3 | Participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle) | TEAEs | 3 | Participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle) | TEAEs | 3 | Participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle) | TEAEs | 7 | Participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle) | TEAEs | 7 | Participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle) | TEAEs | 3 | Participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle) | TEAEs | 3 | Participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle) | TEAEs | 13 | Participants | |
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths | QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle) | TEAEs | 4 | Participants |
1 to 10 of 604Source ClinicalTrials.gov
See all 604 results by groupParticipant flow114
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation Phase | STARTED | Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle) | 4 | |
| Dose Escalation Phase | STARTED | Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle) | 3 | |
| Dose Escalation Phase | STARTED | Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle) | 3 | |
| Dose Escalation Phase | STARTED | Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle) | 3 | |
| Dose Escalation Phase | STARTED | Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle) | 7 | |
| Dose Escalation Phase | STARTED | Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle) | 7 | |
| Dose Escalation Phase | STARTED | Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle) | 3 | |
| Dose Escalation Phase | STARTED | QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle) | 3 | |
| Dose Escalation Phase | STARTED | QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle) | 13 | |
| Dose Escalation Phase | STARTED | QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle) | 4 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 participant flowAdverse events7,258
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 | Constipation | Gastrointestinal disorders | Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle) | 0 | 4 | 0 |
| other | Constipation | Gastrointestinal disorders | Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle) | 1 | 3 | 1 |
| other | Constipation | Gastrointestinal disorders | Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle) | 0 | 3 | 0 |
| other | Constipation | Gastrointestinal disorders | Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle) | 3 | 3 | 3 |
| other | Constipation | Gastrointestinal disorders | Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle) | 3 | 7 | 3 |
| other | Constipation | Gastrointestinal disorders | Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle) | 2 | 7 | 2 |
| other | Constipation | Gastrointestinal disorders | Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle) | 0 | 3 | 0 |
| other | Constipation | Gastrointestinal disorders | QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle) | 0 | 3 | 0 |
| other | Constipation | Gastrointestinal disorders | QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle) | 4 | 13 | 4 |
| other | Constipation | Gastrointestinal disorders | QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle) | 0 | 4 | 0 |
1 to 10 of 7,258Source ClinicalTrials.gov
See all 7,258 adverse eventsAdverse event totals57
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Q2D Dose Escalation Phase: TAK-580 20 mg (22 Days Cycle) | 1 | 4 |
| Total, all-cause mortality | Q2D Dose Escalation Phase: TAK-580 40 mg (22 Days Cycle) | 0 | 3 |
| Total, all-cause mortality | Q2D Dose Escalation Phase: TAK-580 80 mg (22 Days Cycle) | 1 | 3 |
| Total, all-cause mortality | Q2D Dose Escalation Phase: TAK-580 135 mg (22 Days Cycle) | 0 | 3 |
| Total, all-cause mortality | Q2D Dose Escalation Phase: TAK-580 200 mg (22 Days Cycle) | 0 | 7 |
| Total, all-cause mortality | Q2D Dose Escalation Phase: TAK-580 280 mg (22 Days Cycle) | 1 | 7 |
| Total, all-cause mortality | Q2D Dose Escalation Phase: TAK-580 200 mg (28 Days Cycle) | 0 | 3 |
| Total, all-cause mortality | QW Dose Escalation Phase: TAK-580 400 mg (28 Days Cycle) | 0 | 3 |
| Total, all-cause mortality | QW Dose Escalation Phase: TAK-580 600 mg (28 Days Cycle) | 2 | 13 |
| Total, all-cause mortality | QW Dose Escalation Phase: TAK-580 800 mg (28 Days Cycle) | 1 | 4 |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37219686 | 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.
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