Trial · NCT02658890
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With AEs, SAEs, AEs Leading to Discontinuation and Deaths | From first dose to 100 days after last dose (up to 15 months) | Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation and deaths. |
| Primary | Number of Treated Participant With Laboratory Abnormalities - Thyroid | From first dose to 100 days after last dose (up to 15 months) | The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study. Free T3 (FT3) Free T4 (FT4) Thyroid stimulating hormone (TSH) Lower Limit of Normal (LLN) Upper limit of normal (ULN) Results reported in International System of Units (SI) |
| Primary | Number of Treated Participant With Laboratory Abnormalities - Liver | From first dose to 100 days after last dose (up to 15 months) | The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study. Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Results reported in International System of Units (SI) |
| Primary | Number of Participants With a Best Overall Response (BOR) - Parts 2 and 3 | From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks) | Best overall response (BOR) is defined as the best response designation over the study as a whole. Complete response (CR) or partial response (PR) determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met. For those participants who have surgical resection, only pre-surgical tumor assessments will be considered in the determination of BOR. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease. (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Appearance of 1 or more new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Primary | Percentage of Participants With an Objective Response Rate (ORR)- Parts 2 and 3 | From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks) | Objective response rate (ORR) is defined as the percentage of all treated participants whose BOR is either a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. |
| Primary | Median Duration of Response (DoR) - Parts 2 and 3 | From first dose to the date of disease progression, death, or until participants withdraw from the study, whichever occurs first (up to a maximum of 185 weeks) | Duration of response (DoR) was computed for all treated subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. |
| Primary | Progression Free Survival Rate (PFSR) at 24 Weeks - Parts 2 and 3 | At 24 weeks after first dose | Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 24 weeks. Reported values are estimates derived from Kaplan-Meier analyses. |
| Primary | Progression Free Survival Rate (PFSR) at 1 Year - Parts 2 and 3 | At 1 year | Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 1 year. Reported values are estimates derived from Kaplan-Meier analyses. |
| Primary | Progression Free Survival Rate (PFSR) at 2 Years - Parts 2 and 3 | At 2 years | Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at 2 years. Reported values are estimates derived from Kaplan-Meier analyses. |
| Secondary | Cmax | At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks] | Cmax is defined as the maximum observed plasma concentration. Pharmacokinetic parameters measured here are for BMS-986205. |
| Secondary | Tmax | At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks] | Tmax is defined as the time of maximum observed plasma concentration. Pharmacokinetic parameters measured here are for BMS-986205. |
| Secondary | AUC(TAU) | Cycle 0 Day 1 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 0 Day 14 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose) | AUC(TAU) is defined as the area under the concentration-time curve in 1 dosing interval. Pharmacokinetic parameters measured here are for BMS-986205. |
| Secondary | Ctrough | At cycles 0 [up to 2 weeks] and at cycles 3, 5, 7, 10, 11, 13, 15 [each cycle is up to 4 weeks] | Ctrough is defined as the trough observed plasma concentration at the end of the dosing interval. |
| Secondary | CLT/F | At Cycle 0 Day 14 [cycle 0 = up to 2 weeks] | CLT/F is defined as the apparent total body clearance. Pharmacokinetic parameters measured here are for BMS-986205. |
| Secondary | Accumulation Index (AI) - AUC(TAU) | Cycle 0 Day 1 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 0 Day 14 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose) | Accumulation index (AI) of AUC(TAU) is calculated based on the ratio of AUC(TAU) at steady state to after the first dose. Pharmacokinetic parameters measured here are for BMS-986205. |
| Secondary | Accumulation Index (AI) - Cmax | At Cycle 0 Day 14 [cycle 0 = up to 2 weeks] | Accumulation index (AI) of Cmax is calculated based on the ratio of Cmax at steady state to after the first dose. Pharmacokinetic parameters measured here are for BMS-986205. |
| Secondary | Change From Baseline in Serum Kynurenine | At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks] | Pharmacodynamics assessed by change from baseline in serum kynurenine. Changes in kynurenine expression were evaluated in serum samples from participants treated using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Kynurenine is an important metabolite of the IDO-1 Enzyme. Change in Kynurenine levels from baseline is an important indicator of BMS-986205 (IDO1 inhibitor) pharmacodynamic activity. |
| Secondary | Percent Change From Baseline in Serum Kynurenine | At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks] | Pharmacodynamics assessed by change from baseline in serum kynurenine. Changes in kynurenine expression were evaluated in serum samples from participants treated using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Kynurenine is an important metabolite of the IDO-1 Enzyme. Change in Kynurenine levels from baseline is an important indicator of BMS-986205 (IDO1 inhibitor) pharmacodynamic activity. |
| Secondary | Number of Participants With a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies | From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks) | Best overall response (BOR) is defined as the best response designation over the study as a whole. Complete response (CR) or partial response (PR) determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met. For those participants who have surgical resection, only pre-surgical tumor assessments will be considered in the determination of BOR. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease. (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Appearance of 1 or more new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Secondary | Percentage of Participants With an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies | From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks) | Objective response rate (ORR) is defined as the percentage of all treated participants whose BOR is either a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. CR+PR confidence interval based on the Clopper and Pearson method. |
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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