Trial · NCT02206763
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Dose Limiting Toxicities (DLTs) | Up to 28 days | Dose limiting toxicities refer to toxicities experienced during the first 28 days of combined erlotinib and momelotinib (MMB) treatment that have been judged to be clinically significant and related to study treatment. |
| Primary | Safety as Assessed by the Incidence of Adverse Events (AEs) | Up to 2 years plus 30 days | |
| Primary | Safety as Assessed by the Percentage of Participants Experiencing Treatment-Emergent Graded Lab Abnormalities (including Chemistry, Coagulation, Hematology, and Urinalysis) | Up to 2 years plus 30 days | |
| Primary | Change from Baseline in Vital Signs | Up to 2 years | |
| Secondary | Progression-Free Survival | Until disease progression (up to 2 years) | Progression-free survival is defined as the interval from first dose date of study drug (MMB/erlotinib) to the earlier of the first documentation of definitive disease progression or death from any cause; definitive disease progression is progression based on RECIST criteria v1.1. |
| Secondary | Overall Survival | Until disease progression (up to 2 years) | Overall survival is defined as the interval from first dose date of study drug (MMB/erlotinib) to death from any cause. |
| Secondary | Overall Response Rate | Until disease progression (up to 2 years) | Overall response rate is defined as the proportion of participants who achieve a complete response or partial response. |
| Secondary | Pharmacokinetic (PK) Parameter: Cmax of momelotinib (MMB) | Predose and up to 24 hours postdose | Cmax is defined as the maximum observed concentration of drug. |
| Secondary | PK Parameter: AUCtau of momelotinib (MMB) | Predose and up to 24 hours postdose | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). |
| Secondary | PK Parameter: Cmax of Erlotinib | Predose and up to 24 hours postdose | Cmax is defined as the maximum observed concentration of drug. |
| Secondary | PK Parameter: AUCtau of Erlotinib | Predose and up to 24 hours postdose | AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval). |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02206763/registered