Trial · NCT01121575
Outcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 42
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overview of Treatment-emergent All Causalities Adverse Events (AEs) in Escalation Phase | Up to Maximum of treatment duration + 28 days for each participant (could be 295 days) | The safety analysis population included all enrolled participants who had received at least 1 dose of study medication. | participants | NUMBER |
| PRIMARY | Overview of Treatment-emergent All Causalities AEs in Expansion Phase | Up to Maximum of treatment duration + 28 days for each participant (could be 295 days) | The safety analysis population included all enrolled participants who had received at least 1 dose of study medication. | Participants | NUMBER |
| PRIMARY | Overview of Treatment-emergent, Treatment-related AEs in Escalation Phase | Up to Maximum of treatment duration + 28 days for each participant (could be 295 days) | The safety analysis population included all enrolled participants who had received at least 1 dose of study medication. | participants | NUMBER |
| PRIMARY | Overview of Treatment-emergent, Treatment-related AEs in Expansion Phase | Up to Maximum of treatment duration + 28 days for each participant (could be 295 days) | The safety analysis population included all enrolled participants who had received at least 1 dose of study medication. | Participants | NUMBER |
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLTs) in Escalation Phase | Cycle 1 (4 weeks) | The DLT evaluable population was defined as safety analysis (SA) participants in the Dose Escalation phase who did not have a major treatment deviation during the first cycle. | Participants | NUMBER |
| SECONDARY | Number of Participants With Stable Disease and Stable Disease Duration in Escalation Phase | From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment) | The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment. | Participants | NUMBER |
| SECONDARY | Number of Participants With Stable Disease and Stable Disease Duration in Expansion Phase | From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment) | The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment. | Participants | NUMBER |
| SECONDARY | Number of Participants With Objective Response Rate (ORR) in Escalation Phase | From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment) | The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment. | Participants | NUMBER |
| SECONDARY | Number of Participants With ORR in Expansion Phase | From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment) | The response evaluable population included participants in safety analysis population who had an adequate Baseline tumor assessment. | Participants | NUMBER |
| SECONDARY | Duration of Response for the Only Participant Shown Partial Response in Expansion Phase | From objective response to date of progression or death due to any cause, whichever occurs first (up to post treatment follow-up as 28-35 days after last dose of study treatment) | This Outcome Measure was only assessed for participants with response. | Weeks | NUMBER |
| SECONDARY | Progression Free Survival (PFS) in Escalation Phase | From randomization to objective tumor progression or death (up to post treatment follow-up as 28-35 days after last dose of study treatment) | The safety analysis population included all enrolled participants who had received at least 1 dose of study medication. | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) in Expansion Phase | From randomization to objective tumor progression or death (up to post treatment follow-up as 28-35 days after last dose of study treatment) | The safety analysis population included all enrolled participants who had received at least 1 dose of study medication. In Expansion Cohort 1, two participants had censored reasons of no adequate baseline, of which one participant had a censored reason no tumor assessment data available. | Months | MEDIAN |
| SECONDARY | Expression Analysis of Tumor Biomarkers (HGF, EGFR, and c-Met ) at Baseline Using Immunohistochemistry (IHC) Method | Baseline | The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers. | H-Score | MEDIAN |
| SECONDARY | Expression Analysis of Tumor Biomarkers (EGFR, and c-Met) at Baseline Using Fluorescent in Situ Hybridization (FISH) Method | Baseline | The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers. | Ratio | MEDIAN |
| SECONDARY | Number of Participants With c-Met, HER2, EGFR Amplification and ALK Rearrangement at Baseline Using FISH Method | Baseline | The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers. | Participants | NUMBER |
| SECONDARY | Plasma Concentration of sMet by Study Visits | At screening and Cycle 1 Day 1 (C1D1) (6 hours post dose), and C1D15, C2D1, C2D15 (all predose). | The soluble protein analysis population included participants in safety analysis who had a screening or C1D1 soluble protein assessment, and at least one on-treatment soluble protein assessment (C1D14 C2D1 or C2D14). | pg/mL | MEAN |
| SECONDARY | Number of Participants With EGFR Mutation at Baseline | Baseline | The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers. | Participants | NUMBER |
| SECONDARY | Number of Participants With KRAS Mutation (GLY12CYS) at Baseline | Baseline | The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers. | Participants | NUMBER |
| SECONDARY | Number of Participants With PIK3CA Mutation at Baseline | Baseline | The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers. | Participants | NUMBER |
| SECONDARY | Number of Participants With ROS1 Gene Translocation at Baseline | Baseline | The tumor analysis population included participants in safety analysis population who had a screening and on-treatment tumor biopsy for assessment of tumor biomarkers. However, number of participants analyzed in the below table included the participants evaluated for ROS1 gene translocation. | Participants | NUMBER |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01121575/outcomes