Trial · NCT02367651
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 | Progression-free survival (PFS) | At Day 57 and every 8 weeks thereafter until disease progression or death (assessed up to 2 years) | PFS is defined as time from randomization to development of disease progression or death due to any cause. Disease progression will be evaluated based on investigators' radiologic assessments by Response Evaluation Criteria in Solid Tumors \[RECIST\] version 1.1 |
| Secondary | Overall survival (OS) | At Day 57, then every 8 weeks until disease progression, and every 3 months thereafter until death (assessed up to 2 years) | OS is defined as time from randomization to death due to any cause. |
| Secondary | Disease control rate (DCR) | At 4 months after randomization | DCR is defined as percentage of complete response + partial response + stable disease at 4 months after randomization based on RECIST version 1.1. |
| Secondary | Safety and tolerability as assessed by physical examination findings | From Day 1 up to end of treatment (assessed up to 2 years) | A brief physical examination will include height (baseline only), body weight and evaluation of the subject's medical conditions |
| Secondary | Safety and tolerability as assessed by temperature measurement | From Day 1 up to end of treatment (assessed up to 2 years) | |
| Secondary | Safety and tolerability as assessed by systolic and diastolic blood pressure measurement | From Day 1 up to end of treatment (assessed up to 2 years) | |
| Secondary | Safety and tolerability as assessed by pulse rate measurement | From Day 1 up to end of treatment (assessed up to 2 years) | |
| Secondary | Safety and tolerability as assessed by composite of clinical laboratory tests | From Day 1 up to end of treatment (assessed up to 2 years) | Clinical laboratory tests will include chemistry and hematology parameters |
| Secondary | Safety and tolerability as assessed by cardiac assessments | From Day 1 up to end of treatment (assessed up to 2 years) | Cardiac assessments will include twelve-lead electrocardiogram (ECG), echocardiogram (ECHO) or multigated angiogram (MUGA) assessments |
| Secondary | Safety and tolerability as assessed by number of subjects with adverse event | From Day 1 up to end of treatment (assessed up to 2 years) | |
| Secondary | Time to worsening of dyspnea or pain scores as measured by the MD Anderson Symptom Inventory (MDASI) questionnaire | Weekly from baseline up to week 48 | The MDASI is a 19-item general cancer questionnaire asking subjects to rate symptoms at their worst on a scale of 0-10, including pain and shortness of breath as items. Time to symptom deterioration is defined as worsening in tumour pain score or dyspnea score of 2 points or more from baseline, confirmed by at least one additional weekly measure within a four week period. |
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/NCT02367651/registered