Trial · NCT00982865
Trial of MSC1936369B in Subjects With Solid Tumors
NCT00982865, Phase 1, Completed, Merck KGaA, Darmstadt, Germany; results first posted 2018-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of MSC1936369B in Subjects With Solid Tumors. Trials, record NCT00982865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00982865
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of MSC1936369B in Subjects With Solid Tumors
- NCT number
- NCT00982865
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 182 participants, actual
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Conditions
- Solid Tumors, Cancer
- Interventions
- MSC1936369B, MSC1936369B, MSC1936369B, MSC1936369B
- First posted
- 2009-09-23
- Last updated
- 2018-10-23
- Other registries' IDs
- eudract:2007-004665-18
- Results first posted
- 2018-10-23
Source ClinicalTrials.gov
Registered outcomes46
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) Over the First Cycle - Day 1 to 21 | Day 1 up to Day 21 of Cycle 1 | DLT was defined as any of following toxicities at any dose level according to using National Cancer Institute Common Terminology Criteria for Adverse Events (AEs) v3.0(CTCAE), probably or possibly related to trial medication by investigator or sponsor: a)Any Grade 3 or more non-haematological toxicity excluding: (i)Grade 3 asymptomatic increase in liver function tests (Aspartate Aminotransferase, Alanine transaminase, Alkaline Phosphatase reversible within 7 days for subjects without liver involvement, or grade 4 for subjects with liver involvement; (ii)Grade 3 vomiting if it is encountered despite adequate and optimal therapy (e.g. serotonin \[5HT3\] antagonists and corticosteroids); (iii)Grade 3 diarrhoea if it is encountered despite adequate and optimal anti diarrhoea therapy; b)Grade 4 neutropenia of \>5 days duration or febrile neutropenia lasting for more than 1 day; c)Grade 4 thrombocytopenia \>1 day or grade 3 with bleeding; d)Any treatment delay \>2 weeks due to drug-related AEs. |
| Secondary | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation | Baseline up to 253 weeks | AE was defined as any untoward medical occurrence which does not necessarily have a causal relationship with this the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious AE 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 or was otherwise considered medically important. Treatment-emergent are events between first dose of study drug and up to 253 weeks. TEAEs include both Serious TEAEs and non-serious TEAEs. |
| Secondary | Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Leading to Death | Baseline up to 253 weeks | |
| Secondary | Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events | Baseline up to 253 weeks | Any clinically significant changes in laboratory evaluations and vital signs were recorded as treatment emergent adverse events. The clinical laboratory parameters that were assessed included: Hematological parameters, Blood chemistry parameters, Urinalysis and the vital signs that were assessed included: Blood pressure, Heart rate, Temperature and Weight. SAF analysis was used. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours (h) post-dose on Cycle 1(C1) Day 1 (D1), Cycle 1 Day 12 (D12) and Cycle 3 (C3) Day 1 | Pharmacokinetic (PK) parameter Cmax was obtained directly from the concentration versus time curve. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (Without Food Effect) | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1 | Cmax was obtained directly from the concentration versus time curve. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (With Food Effect) | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2 | Cmax was obtained directly from the concentration versus time curve. Summarized data over Day 1 and Day 2 was reported. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Once Daily | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1 | Cmax was obtained directly from the concentration versus time curve. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Twice Daily | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1 | Cmax was obtained directly from the concentration versus time curve. |
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1 | Time to reach the maximum plasma concentration (Tmax) was obtained directly from the concentration versus time curve. |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 registered outcomesOutcomes46
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) Over the First Cycle - Day 1 to 21 | Day 1 up to Day 21 of Cycle 1 | Dose Escalation Analysis Set included all subjects who meet at least 1 of following criteria:~subjects who experienced any DLT during Cycle 1 \& who received planned treatment. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation | Baseline up to 253 weeks | Safety Analysis Set (SAF) included all subjects who received at least 1 dose of MSC1936369B treatment. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) Leading to Death | Baseline up to 253 weeks | ALL subject analysis set was used which included all the subjects who signed the informed consent form and entered the study. | Subjects | NUMBER |
| SECONDARY | Number of Subjects With Clinical Significant Laboratory Abnormalities and Vital Signs Reported as Treatment Emergent Adverse Events | Baseline up to 253 weeks | SAF analysis was used. | Subjects | NUMBER |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours (h) post-dose on Cycle 1(C1) Day 1 (D1), Cycle 1 Day 12 (D12) and Cycle 3 (C3) Day 1 | PK analysis set: subjects received at least 1 dose of drug \& provided sufficient PK serum samples for at least 1st 24h following 1st dose of C1D1. Number of Participants Analyzed=subjects evaluable for this endpoint \& Number analyzed=subjects evaluated at specified time point \& 0indicates no subject analyzed for that specific time point. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (Without Food Effect) | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1 | PKS analysis set. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure and Number analyzed signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 2 (With Food Effect) | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, 12 and 24 hours post-dose on Cycle 1 Day 1 and Day 2 | The food effect analysis set included all subjects who fulfilled following conditions: Food \& drink intake, trial medication administration according to protocol, \& not excreted irregularly, PK samples collected. Here Number of Participants Analyzed signifies those subjects who were evaluable for this endpoint. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Once Daily | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 3 Day 1 | PKS analysis set. Here Number Analyzed signifies the subjects who were evaluated at that specified time point. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of MSC1936369B: Regimen 3 Twice Daily | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8, and 10 h post-dose on Cycle 1 Day 1 and Day 15; pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 h post dose on Cycle 3 Day 1 | PKS analysis set. Here Number analyzed signifies those who were evaluated at the specified time point. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Reach Maximum Plasma Concentration (Tmax) of MSC1936369B: Regimen 1 | Pre-dose, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 1, Cycle 1 Day 12 and Cycle 3 Day 1 | PKS analysis set. Here Number of Participants Analyzed signifies those subjects who were evaluable for this outcome measure and Number analyzed signifies those who were evaluated at the specified time point. Data was not available for categories with Number analyzed= 0 as no subject analyzed at specified time point. | Hours (h) | MEDIAN |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 outcomesResults by group939
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) Over the First Cycle - Day 1 to 21 | MSC1936369B Regimen 1 | 2 | Subjects | ||
| Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) Over the First Cycle - Day 1 to 21 | MSC1936369B Regimen 2 (Without Food Effect + With Food Effect) | 6 | Subjects | ||
| Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) Over the First Cycle - Day 1 to 21 | MSC1936369B Regimen 3 Once Daily (QD) | 0 | Subjects | ||
| Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) Over the First Cycle - Day 1 to 21 | MSC1936369B Regimen 3 Twice Daily | 6 | Subjects | ||
| Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation | MSC1936369B Regimen 1 | TEAEs | 47 | Subjects | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation | MSC1936369B Regimen 2 (Without Food Effect + With Food Effect) | TEAEs | 82 | Subjects | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation | MSC1936369B Regimen 3 Once Daily (QD) | TEAEs | 15 | Subjects | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation | MSC1936369B Regimen 3 Twice Daily | TEAEs | 34 | Subjects | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation | MSC1936369B Regimen 1 | Serious TEAEs | 23 | Subjects | |
| Number of Subjects With Treatment-Emergent Adverse Events (TEAE), Serious TEAEs, TEAEs Leading to Discontinuation | MSC1936369B Regimen 2 (Without Food Effect + With Food Effect) | Serious TEAEs | 45 | Subjects |
1 to 10 of 939Source ClinicalTrials.gov
See all 939 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MSC1936369B Regimen 1 | 49 | |
| Overall Study | STARTED | MSC1936369B Regimen 2 (Without Food Effect + With Food Effect) | 82 | |
| Overall Study | STARTED | MSC1936369B Regimen 3 Once Daily (QD) | 15 | |
| Overall Study | STARTED | MSC1936369B Regimen 3 Twice Daily (BID) | 34 | |
| Overall Study | COMPLETED | MSC1936369B Regimen 1 | 49 | |
| Overall Study | COMPLETED | MSC1936369B Regimen 2 (Without Food Effect + With Food Effect) | 82 | |
| Overall Study | COMPLETED | MSC1936369B Regimen 3 Once Daily (QD) | 15 | |
| Overall Study | COMPLETED | MSC1936369B Regimen 3 Twice Daily (BID) | 34 | |
| Overall Study | NOT COMPLETED | MSC1936369B Regimen 1 | 0 | |
| Overall Study | NOT COMPLETED | MSC1936369B Regimen 2 (Without Food Effect + With Food Effect) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,984
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 | Hypertension | Vascular disorders | MSC1936369B Regimen 1 | 7 | 49 | |
| other | Hypertension | Vascular disorders | MSC1936369B Regimen 2 (Without Food Effect + With Food Effect) | 4 | 82 | |
| other | Hypertension | Vascular disorders | MSC1936369B Regimen 3 Once Daily (QD) | 1 | 15 | |
| other | Hypertension | Vascular disorders | MSC1936369B Regimen 3 Twice Daily | 4 | 34 | |
| other | Hot flush | Vascular disorders | MSC1936369B Regimen 1 | 4 | 49 | |
| other | Hot flush | Vascular disorders | MSC1936369B Regimen 2 (Without Food Effect + With Food Effect) | 1 | 82 | |
| other | Hot flush | Vascular disorders | MSC1936369B Regimen 3 Once Daily (QD) | 0 | 15 | |
| other | Hot flush | Vascular disorders | MSC1936369B Regimen 3 Twice Daily | 0 | 34 | |
| other | Hypotension | Vascular disorders | MSC1936369B Regimen 1 | 3 | 49 | |
| other | Hypotension | Vascular disorders | MSC1936369B Regimen 2 (Without Food Effect + With Food Effect) | 1 | 82 |
1 to 10 of 1,984Source ClinicalTrials.gov
See all 1,984 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MSC1936369B Regimen 1 | ||
| Total, all-cause mortality | MSC1936369B Regimen 2 (Without Food Effect + With Food Effect) | ||
| Total, all-cause mortality | MSC1936369B Regimen 3 Once Daily (QD) | ||
| Total, all-cause mortality | MSC1936369B Regimen 3 Twice Daily | ||
| Total, other adverse events | MSC1936369B Regimen 1 | 47 | 49 |
| Total, other adverse events | MSC1936369B Regimen 2 (Without Food Effect + With Food Effect) | 80 | 82 |
| Total, other adverse events | MSC1936369B Regimen 3 Once Daily (QD) | 15 | 15 |
| Total, other adverse events | MSC1936369B Regimen 3 Twice Daily | 34 | 34 |
| Total, serious adverse events | MSC1936369B Regimen 1 | 23 | 49 |
| Total, serious adverse events | MSC1936369B Regimen 2 (Without Food Effect + With Food Effect) | 45 | 82 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT00982865
GET https://conductscience.org/api/trials/v1/NCT00982865/registered?page=2