Trial · NCT02637531
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part A/B/C: Dose Limiting Toxicities (DLT) | From date of initial dose until up to 28 days for IPI-549 | |
| Primary | Part D/E: Adverse Events (AE) and safety laboratory values | Number of patients with Clinically significant abnormal laboratory values and adverse events that are related to treatment from date of initial dose until 30 days after last dose of IPI-549 and 100 days after the last dose of Nivolumab | |
| Secondary | Part A/B: Adverse Events (AE) and safety laboratory values | Number of patients with Clinically significant abnormal laboratory values and adverse events that are related to treatment assessed during every visit for duration of study participation which is estimated to be 24 months | |
| Secondary | Part A/B: Plasma concentrations of IPI-549 (metabolites, as appropriate) | Assessed during Days 1- 22 of Cycles 1 and 2, Assessed During Day 1 of Cycles 3 and 4 | |
| Secondary | Part A/B: Overall response rate (ORR), complete response/remission (CR) or partial response/remission (PR) | Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year | |
| Secondary | Part A/B: Duration of response (DoR) | Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year | |
| Secondary | Part C: Adverse Events (AE) and safety laboratory values | Number of patients with Clinically significant abnormal laboratory values and adverse events that are related to treatment assessed during every visit for duration of study participation which is estimated to be 24 months | |
| Secondary | Part C: Plasma concentrations of IPI-549 (metabolites as appropriate) | Assessed during Days 1- 2 of Cycles 1 and 2 | |
| Secondary | Part C: Overall Response Rate (ORR) | Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year | |
| Secondary | Part C: Duration of Response (DoR) | Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year | |
| Secondary | Part D: Overall Response Rate (ORR) | Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year | |
| Secondary | Part D: Duration of Response (DoR) | Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year | |
| Secondary | Part D: Progression-Free Survival (PFS) | Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year | |
| Secondary | Part D: Overall Survival (OS) | Estimated to be 3 years | |
| Secondary | Part D: Plasma concentrations of IPI-549 (and metabolites, as appropriate) | Assessed during Days 1- 15 of Cycles 1 and 2, Assessed During Day 1 of Cycles 3 and 4 | |
| Secondary | Part E:Overall Response Rate (ORR) | Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year | |
| Secondary | Part F:Overall Response Rate (ORR) | Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year | |
| Secondary | Part G:Overall Response Rate (ORR) | Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year | |
| Secondary | Part E: Duration of Response (DoR) | Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year | |
| Secondary | Part F: Duration of Response (DoR) | Responses Assessed in Cycle 3 and every odd cycle through study completion, an average of 1 year |
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/NCT02637531/registered