Trial · NCT00920140
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) by Dose | From the start of the study drug until the final study visit (up to approximately 407 days) | All Treated Population: all participants who received at least one dose of study medication. Safety data was evaluated based on this population. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Hematology Parameters by Dose | From the start of the study drug until the final study visit (up to approximately 407 days) | All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants With a Change From Baseline Grade to Grade 3 and 4 for the Indicated Clinical Chemistry Parameters by Dose | From the start of the study drug until the final study visit (up to approximately 407 days) | All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants With a Change From Baseline in Heart Rate by Dose | From the start of the study drug until the final study visit (up to approximately 407 days) | All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants With a Change From Baseline in Systolic and Diastolic Blood Pressure by Dose | From the start of the study drug until the final study visit (up to approximately 407 days) | All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants With a Change From Baseline in Temperature by Dose | From the start of the study drug until the final study visit (up to approximately 407 days) | All Treated Population (ATP). Only those par. available at the specified time points were analyzed. Different par. may have been analyzed for different parameters; the overall number analyzed reflects everyone in the ATP. One Phase 2 par. was incorrectly dosed (received \<2 mg \[0.5 mg\]); thus, 6 par. receiving GSK1120212 \<2 mg OD were analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants With an Investigator-assessed Best Response (Achieving Complete Response [CR], Marrow CR, Partial Response [PR], Complete Response Without Platelet Recovery [CRp] or Morphologic Leukaemia-free State[MLFS]) by Cohort | From the start of the study drug until the final study visit (up to approximately 407 days) | Efficacy Population: all participants included in the All Treated Population who had received at least one dose of 2 mg of study drug in Phase 2. The number of participants for the Cohort 2: AML/MDS/CMML with RAS wt/Unknown treatment group is equal to the 8 participants from Phase 1 plus the 22 participants from Phase 2 (total of 30). | Participants | NUMBER |
| SECONDARY | AUC(0-24), AUC(0-t), and AUC(0-tau) of GSK1120212 in Part 1 | Cycle 1 Day 1 and Cycle 1 Day 15 | Pharmacokinetic Population: all participants included in the All Treated Population for whom a PK sample was obtained and analyzed. Only participants with data available at the indicated time points were analyzed. | nanograms*hour/milliliter | GEOMETRIC_MEAN |
| SECONDARY | Cmin and Cmax of GSK1120212 in Part 1 | Cycle 1 Day 1 and Cycle 1 Day 15 | Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | t1/2 at C1D1 and t1/2 Effective (Eff.) at C1D15 of GSK1120212 in Part 1 | Cycle 1 Day 1 (t1/2) and Cycle 1 Day 15 (t1/2eff) | Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed. | Hours | GEOMETRIC_MEAN |
| SECONDARY | Tmax of GSK1120212 in Part 1 | Cycle 1 Day 1 and Cycle 1 Day 15 | Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed. | Hours | MEDIAN |
| SECONDARY | Accumulation Ratio (AR) of GSK1120212 in Part 1 | Cycle 1 Day 1 and Cycle 1 Day 15 | Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed. | Ratio | GEOMETRIC_MEAN |
| SECONDARY | Ctau of GSK1120212 in Part 2 | C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, C7D1, C8D1, C9D1, C10D1, C11D1 and C12D1 | Pharmacokinetic Population. Only participants with data available at the indicated time points were analyzed. | nanograms per milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Overall Survival by Cohort | From the start of the study drug until the final study visit (up to approximately 407 days ) | Efficacy Population. The number of participants for the Cohort 2: AML/MDS/CMML with RAS wt/Unknown treatment group is equal to the 8 participants from Phase 1 plus the 22 participants from Phase 2 (total of 30). | Months | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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