Comparison · NCT02514824-451ef18b
Dose Level 1: MLN01283 3 mg (Phase 1) vs Dose Level 2: MLN01283 4 mg (Phase 1): Dose Limiting Toxicity (DLT) [Phase I]
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. 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, record NCT02514824-451ef18b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02514824-451ef18b
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk in group 2 | 0.4 | 0.118 | 0.769 | wilson | |
| Risk difference, group 1 minus group 2 | -0.4 | -0.769 | 0.229 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat, for one fewer participant with the outcome on Dose Level 1: MLN01283 3 mg (Phase 1) than on Dose Level 2: MLN01283 4 mg (Phase 1) | 2.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Dose Level 1: MLN01283 3 mg (Phase 1) | Phase 1 dose level 1 participants receive MLN01283 3mg orally once daily of a 28 day cycle.~Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons. | 0 | 3 | OG000 |
| Group 2 | Dose Level 2: MLN01283 4 mg (Phase 1) | Phase 1 dose level 2 participants receive MLN01283 4 mg orally once daily of a 28 day cycle.~Participants are treated indefinitely until disease progression, unacceptable toxicity or withdrawal for other reasons. | 2 | 5 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Dose Limiting Toxicity (DLT) [Phase I]
- Description
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.
- Time frame
- The observation period for DLT evaluation was the first 28 days (cycle 1) of treatment.
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma
- NCT number
- NCT02514824
- Phases
- PHASE1, PHASE2
- Conditions
- Merkel Cell Carcinoma
- Interventions
- MLN0128
- Lead sponsor
- Dana-Farber Cancer Institute
- Results first posted
- 2020-12-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02514824?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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