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A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IPI-549

NCT02637531 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2022-04-04

No results posted yet for this study

Summary

This dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IPI-549 monotherapy and IPI-549 in combination with nivolumab in subjects with advanced solid tumors.

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

DRUG

IPI-549 (eganelisib)

IPI-549 daily dose administered orally in 28-day cycles (Part A/BC/D/D-Annex/E)

DRUG

Nivolumab

Nivolumab (240 mg, Q2W) administered intravenously (IV) in 28-day cycles (Part C/D-Annex/E).

Sponsors & Collaborators

  • Infinity Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Feng Chi, MD · Infinity Pharmaceutical, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2022-01-31
Completion
2022-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02637531 on ClinicalTrials.gov