Trial · NCT01390818
Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT01390818, Phase 1, Completed, EMD Serono; results first posted 2017-03-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors. Trials, record NCT01390818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01390818
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors
- NCT number
- NCT01390818
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 146 participants, actual
- Lead sponsor
- EMD Serono
- Conditions
- Locally Advanced Solid Tumor, Metastatic Solid Tumor, Breast Cancer, Non Small Cell Lung Cancer, Melanoma, Colorectal Cancer
- Interventions
- MSC1936369B (pimasertib), SAR245409 (PI3K and mTOR inhibitor), MSC1936369B (pimasertib), SAR245409 (PI3K and mTOR inhibitor)
- First posted
- 2011-07-11
- Last updated
- 2017-03-07
- Results first posted
- 2017-03-07
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Dose Limiting Toxicities (DLT) | Day 1 up to Day 16 in cycle 1 | DLT was defined as any of the following toxicities experienced during the first cycle of treatment at any dose level (DL) and judged not to be related to the underlying disease or any concomitant medication by the Investigator and/or the Sponsor: A treatment emergent adverse event (TEAE) of potential clinical significance such that further dose escalation (DE) would have exposed subjects to unacceptable risk. Any Grade greater than or equal to (\>=) 3 non-hematological toxicity, except for: Grade 3 diarrhea, nausea and vomiting with a duration less than or equal to (\<=) 48 hours despite adequate supportive care and Alopecia. Grade 4 neutropenia of \> 5 days duration or febrile neutropenia. Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia. Any treatment interruption \> 2 weeks due to AEs not related to the underlying disease or concomitant medication at any dose level and any severe, life-threatening impairing daily functions complication or abnormality. |
| Secondary | Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs) | Baseline up to 30 Days after last dose; assessed up to 4 years | An adverse event (AE) was defined as any untoward medical occurrence in a subject administered a pharmaceutical product, which did not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs were defined as those AEs that started between first dose of study drug and up to 30 days after last dose. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B) | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | |
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib (MSC1936369B) | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | |
| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of Pimasertib (MSC1936369B) | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | Area under the concentration-time curve from time 0 to the last quantifiable concentration. |
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of Pimasertib (MSC1936369B) at Day 1 | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts | Area under the concentration-time curve from time 0 extrapolated to infinity, calculated as AUC0-t + last observed concentration (Clast)/terminal rate constant (λz), using the Linear up/Log down method. Terminal rate constant (λz). |
| Secondary | Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of Pimasertib (MSC1936369B) | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | |
| Secondary | Half-Life (t1/2) of MSC1936369B (Pimasertib) | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | |
| Secondary | Total Body Clearance (CL/f) of Pimasertib (MSC1936369B) | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | The total body clearance of drug from plasma following oral administration (Cl/f) and the total body clearance of drug from plasma following intravenous administration was calculated by dividing the Dose with area under the plasma concentration time curve from time zero to infinity (AUC0 inf)=Dose/AUC0- inf. |
| Secondary | Apparent Volume of Distribution of Total Pimasertib During the Terminal Phase Following Oral Administration (Vz/f) of Pimasertib | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/f) was influenced by the fraction absorbed. Apparent volume of distribution during the terminal phase, calculated by CL/f/λz. Terminal rate constant (λz). The regression analysis (determination of λz) was to contain as many data points as possible (but excluding Cmax) and had to include concentration data from at least 3 different time points, consistent with the assessment of a straight line (the terminal elimination phase) on the log-transformed scale.Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of Vz/f. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Dose Limiting Toxicities (DLT) | Day 1 up to Day 16 in cycle 1 | The dose escalation (DE) analysis set included all subjects treated in DE cohorts who received at least 80 percent (%) of pimasertib and 80% of SAR245409 full planned doses in the first cycle (ie, 21-day period from Day 1) of treatment or who experienced a DLT during the first cycle of treatment regardless of the received amount of each drug. | subjects | NUMBER |
| SECONDARY | Number of Subjects Experiencing Any Treatment-Emergent Adverse Events (TEAEs) | Baseline up to 30 Days after last dose; assessed up to 4 years | The safety analysis set (SAF) analysis set was to include all subjects who had received at least 1 (non-zero) administration of the trial investigational medicinal products (IMPs) MSC1936369B (pimasertib) and/or SAR245409. | subjects | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) for Pimasertib (MSC1936369B) | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | The pharmacokinetic (PK) analysis set. Here n signifies the number of subjects evaluable at the specific time points. | nanogram/millilitre (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Plasma Concentration (Tmax) of Pimasertib (MSC1936369B) | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | The PK analysis set. Here n signifies the number of subjects evaluable at the specific time points. | hour | MEDIAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to the Last Sampling Time (0-24 Hours) of Pimasertib (MSC1936369B) | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | The PK analysis set . Here n signifies the number of subjects evaluable at the specific time points. | hour*nanogram per millilitre (hr*ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC 0-inf) of Pimasertib (MSC1936369B) at Day 1 | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1 for DE cohorts | The PK analysis set. Here N signifies the number of subjects evaluable for this outcome measure. Data was not available for 'Pimasertib (MSC1936369B) 60mg Twice Daily' arm as no subjects were considered evaluable because of limited number of samples collected to characterize the terminal phase rate constant needed for the calculation of AUCinf. | hr*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Concentration-Time Curve (AUC) During a Dosing Interval (Tau) of Pimasertib (MSC1936369B) | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | The PK analysis set. Here n signifies the number of subjects evaluable at the specific time points. | hr*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Half-Life (t1/2) of MSC1936369B (Pimasertib) | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | The PK analysis set. Here n signifies the number of subjects evaluable at the specific time points. | hour | MEDIAN |
| SECONDARY | Total Body Clearance (CL/f) of Pimasertib (MSC1936369B) | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and n signifies the number of subjects evaluable at the specific time points. | litre per hour (L/hr) | GEOMETRIC_MEAN |
| SECONDARY | Apparent Volume of Distribution of Total Pimasertib During the Terminal Phase Following Oral Administration (Vz/f) of Pimasertib | Predose 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hour post dose on Day 1, 15 for DSE Cohorts; Predose 0.5, 1, 1.5, 2, 3, 4, 8, 10 and 24 hour post dose on Day 1, 15 for DE cohorts | The PK analysis set. Here N signifies number of subjects evaluable for this outcome measure and n signifies the number of subjects evaluable at specific time points. | liter | GEOMETRIC_MEAN |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group802
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Dose Limiting Toxicities (DLT) | Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily | 0 | subjects | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) | Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily | 0 | subjects | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) | Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily | 0 | subjects | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) | Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily | 0 | subjects | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) | Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily | 0 | subjects | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) | Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily | 0 | subjects | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) | Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily | 0 | subjects | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) | Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily | 2 | subjects | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) | Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily | 1 | subjects | ||
| Number of Subjects With Dose Limiting Toxicities (DLT) | Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily | 2 | subjects |
1 to 10 of 802Source ClinicalTrials.gov
See all 802 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily | 3 | |
| Overall Study | STARTED | Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily | 3 | |
| Overall Study | STARTED | Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily | 3 | |
| Overall Study | STARTED | Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily | 4 | |
| Overall Study | STARTED | Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily | 4 | |
| Overall Study | STARTED | Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily | 3 | |
| Overall Study | STARTED | Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily | 19 | |
| Overall Study | STARTED | Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily | 14 | |
| Overall Study | STARTED | Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily | 3 | |
| Overall Study | STARTED | Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily | 3 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events7,005
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 | ANAEMIA | Blood and lymphatic system disorders | MSC1936369B (Pimasertib) 15mg and SAR245409 30mg Once Daily | 1 | 3 | |
| other | ANAEMIA | Blood and lymphatic system disorders | MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily | 0 | 3 | |
| other | ANAEMIA | Blood and lymphatic system disorders | MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily | 2 | 3 | |
| other | ANAEMIA | Blood and lymphatic system disorders | MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily | 1 | 4 | |
| other | ANAEMIA | Blood and lymphatic system disorders | MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily | 1 | 4 | |
| other | ANAEMIA | Blood and lymphatic system disorders | MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily | 0 | 3 | |
| other | ANAEMIA | Blood and lymphatic system disorders | MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily | 7 | 19 | |
| other | ANAEMIA | Blood and lymphatic system disorders | MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily | 3 | 14 | |
| other | ANAEMIA | Blood and lymphatic system disorders | MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily | 1 | 3 | |
| other | ANAEMIA | Blood and lymphatic system disorders | MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily | 0 | 3 |
1 to 10 of 7,005Source ClinicalTrials.gov
See all 7,005 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MSC1936369B (Pimasertib) 15mg and SAR245409 30mg Once Daily | ||
| Total, all-cause mortality | MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily | ||
| Total, all-cause mortality | MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily | ||
| Total, all-cause mortality | MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily | ||
| Total, all-cause mortality | MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily | ||
| Total, all-cause mortality | MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily | ||
| Total, all-cause mortality | MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily | ||
| Total, all-cause mortality | MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily | ||
| Total, all-cause mortality | MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily | ||
| Total, all-cause mortality | MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse event totalsPapers0
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 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/NCT01390818
GET https://conductscience.org/api/trials/v1/NCT01390818/registered?page=2