Trial · NCT02637531
A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549
NCT02637531, Phase 1, Unknown, Infinity Pharmaceuticals, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549. Trials, record NCT02637531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02637531
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549
- NCT number
- NCT02637531
- Status
- Unknown
- Phases
- Phase 1
- Enrollment
- 219 participants, actual
- Lead sponsor
- Infinity Pharmaceuticals, Inc.
- Conditions
Advanced Solid Tumors (Part A/B/C/D), Non-small Cell Lung Cancer (Part E), Melanoma (Part E), Squamous Cell Cancer of the Head and Neck (Part E), Triple Negative Breast Cancer (Part F), Adrenocortical Carcinoma (Part G), Mesothelioma (Part G), High-circulating Myeloid-derived Suppressor Cells (Part H)
- Interventions
- IPI-549 (eganelisib), Nivolumab
- First posted
- 2015-12-22
- Last updated
- 2022-04-04
Source ClinicalTrials.gov
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39214650 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02637531
GET https://conductscience.org/api/trials/v1/NCT02637531/registered?page=2