Trial · NCT02181634
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Rate at 6 Months (Proportion of Participants Alive and Progression-Free at 6 Months) | Assessed at 6 months | Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first. Progression-free survival rate at 6 months is defined as the proportion of patients who were disease progression-free and alive at 6 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the diameter/axes of target lesions, taking as reference the smallest sum on study, or unequivocal progression of existing non-target lesions, or the appearance of new lesions. |
| Secondary | Overall Survival (OS) | Every 3-6 months for up to 3 years | OS is defined as the time from enrollment until death or last patient contact. |
| Secondary | Progression-free Survival (PFS) | Every 3-6 months for up to 3 years | Progression-free survival is defined as the time from the date of first study treatment to either the date of documented disease progression or death from any cause, whichever occurred first. |
| Secondary | Time To Progression (TTP) | Every 3-6 months for up to 3 years | TTP was defined as the time from date of first dose of study therapy to date of removal from study for progression. Patients who have not experienced progression were censored at the date of last disease evaluation. Progression is evaluated using Solid Tumor Response Criteria (RECIST) Version 1.1. Progression is defined as at least a 20% increase in the sum of the diameters/axes of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm over the nadir. The appearance of new lesions or unequivocal progression of existing non-target lesions also constitutes disease progression. |
| Secondary | Overall Response Rate (ORR) | Every 3-6 months for up to 3 years | Overall response rate is defined as the proportion of patients with complete response or partial response per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. A confirmation assessment performed \>=4 weeks after the criteria for response is met is required. |
| Secondary | Disease Control Rate (DCR) | Every 3-6 months for up to 3 years | Disease control rate is the proportion of patients achieved complete response, partial response or stable disease per RECIST version 1.1. Complete response is defined as disappearance of all lesions. Partial response is defined as at least a 30% decrease in the sum of the diameters/axes of target lesions and the persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker levels above the normal limits. Stable disease is defined as neither sufficient shrinkage to qualify for complete or partial response nor sufficient increase to qualify for progression. A confirmation assessment performed \>=4 weeks after the criteria for response is met is required. |
| Secondary | Association Between PFS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline | CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment | Patients were dichotomized into maximum CA 19-9 decline \>=50% and maximum CA 19-9 decline \<50%. Cox proportional hazards model was used to evaluate the association between PFS and maximum change in CA 19-9. |
| Secondary | Association Between OS and Maximum Change in Carbohydrate Antigen (CA) 19-9 From Baseline | CA 19-9 was evaluated every 8 weeks until progression or for up to 3 years and off-treatment | Patients were dichotomized into maximum CA 19-9 decline \>=50% and maximum CA 19-9 decline \<50%. Cox proportional hazards model was used to evaluate the association between OS and maximum change in CA 19-9. |
| Other | Change in Circulating Tumor Cells (CTCs) | Prior to Cycle 1, Day 1; Cycle 1 Day 8; Cycle 3, Day 1 and at Off Treatment | Correlate change in CTCs to median PFS, OS, TTP, ORR and DCR. |
| Other | Stromal SPARC Expression | Baseline | Correlate stromal SPARC (high versus low) expression by immunohistochemistry (IHC) with median PFS, OS, TTP, ORR and DCR. |
| Other | Fibrosis Expression | Baseline | Correlate fibrosis (low, intermediate and high) by trichrome staining with median PFS, OS, TTP, ORR and DCR. |
| Other | CDA Expression | Baseline | Correlate CDA (high versus low) expression by IHC with median PFS, OS, TTP, ORR and DCR. |
| Other | hENT Expression | Baseline | Correlate hENT1 (high versus low) expression by IHC with median PFS, OS, TTP, ORR and DCR. |
| Other | Banking Biospecimens for Future Assessment | Prior to Cycle 1, Day 1; Cycle 1, Day 8; Cycle 3, Day 1 and at Off Treatment | Optional specimen banking of patient blood specimens (including serum, plasma and buffy coat) as well as fixed left-over tissue specimens when available from all enrolled patients in this trial for possible future molecular, pharmacogenomic, and/or proteomic testing. |
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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GET https://conductscience.org/api/trials/v1/NCT02181634/registered