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NCT01014936 · ClinicalTrials.gov registry record · Phase 1
First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors
A Phase 1 study of Patients With Solid Tumors, Either Refractory to Standard Therapy or for Which no Effective Standard Therapy is Available, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 1
- Development phase
- 149
- Enrollment target
- 1
- Study location
NCT01014936: Completed Phase 1 study of Patients With Solid Tumors, Either Refractory to Standard Therapy or for Which no Effective Standard Therapy is Available, sponsored by EMD Serono.
NCT01014936 is a Phase 1 study of Patients With Solid Tumors, Either Refractory to Standard Therapy or for Which no Effective Standard Therapy is Available that has completed, run by EMD Serono. The registered enrollment target is 149 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (148% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01014936, a Phase 1 study of Patients With Solid Tumors, Either Refractory to Standard Therapy or for Which no Effective Standard Therapy is Available, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 149 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will be assigned one of the dosing regimens: * Regimen 1: MSC2156119J once daily for 14 days, followed by 7 days with no treatment (21-day cycle) * Regimen 2: MSC2156119J three times per week (e.g., Days 1, 3, and 5) for three weeks (21-day cycle) * Regimen 3: MSC2156119J every day for three weeks (21-day cycle)
Primary Outcome
DLT was defined as one of the following adverse events (AEs) observed during Cycle1, regardless of MSC2156119J relationship, excluding AEs assessed by investigator exclusively related to subject's underlying disease or medical condition: Grade 4 neutropenia for \>7 days; Grade \>=3 febrile neutropenia for \>1 day; Grade 4 thrombocytopenia/Grade 3 with bleeding; Grade \>=3 nausea and emesis, despite optimal treatment; Grade \>=3 non-hematological AE, except emesis and nausea with no adequate ther
Conditions Studied
Interventions
- DRUG MSC2156119J
Study Locations (1)
Texas
- M.D. Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2009-11-30 |
| Est. Completion | 2015-10-31 |
| Phase | Phase 1 |
What the finished NCT01014936 record still lists
NCT01014936 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (148% higher).
The record links to 1 condition, with Patients With Solid Tumors, Either Refractory to Standard Therapy or for Which no Effective Standard Therapy is Available appearing as the primary indexed condition, and to 1 intervention - of which MSC2156119J is the first listed.
NCT01014936 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01014936 about?
NCT01014936 is a clinical study titled "First-in-Man, Dose-escalation Trial of C-met Kinase Inhibitor MSC2156119J in Subjects With Advanced Solid Tumors". This is a an open-label, dose-escalation, first-in-man (FIM) study designed to explore MSC2156119J, in subjects with advanced solid tumors who have not responded to previous therapies or for whom no other therapies are available. Subjects will be assigned one of the dosing regimens: * Regimen 1: M...
What is the current status of trial NCT01014936?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 149 participants. The study started on 2009-11-30. Estimated completion is 2015-10-31.
What conditions does trial NCT01014936 study?
This clinical trial studies the following conditions: Patients With Solid Tumors, Either Refractory to Standard Therapy or for Which no Effective Standard Therapy is Available.
What interventions are being tested in trial NCT01014936?
The interventions under investigation include: MSC2156119J (DRUG).
Who is sponsoring clinical trial NCT01014936?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01014936 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01014936's enrollment target sits among peer trials
149 381st of 2000 higher than 1,619 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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