A Long-term, Continued Treatment and Follow-up Study in Participants With Hematologic Malignancies Treated With Duvelisib (IPI-145)

NCT02711852 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IPI-145-23
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 5

Brief Summary

This was a long-term, continued treatment study that evaluated the long-term safety, clinical activity, and overall survival (OS) of duvelisib in individuals with hematologic malignancies that were previously treated with duvelisib in a previous sponsor-approved study.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

  A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

  Up to 45 months

Secondary Outcomes (2)

• Best Overall Response (BOR) to Duvelisib as Assessed by the Investigator

  Up to 45 months

• Overall Survival (OS)

  Up to 45 months

Study Arms (1)

Duvelisib

EXPERIMENTAL

Participants received the same dose from their previous duvelisib study. All doses were taken twice daily. Two dose reductions were allowed per participant, but doses were not less than 10 milligrams (mg). Participants received duvelisib until disease progression or unacceptable toxicity.

Drug: Duvelisib

Interventions

Duvelisib DRUG

Administered as oral capsules

Also known as: IPI-145, VS-0145, COPIKTRA

Duvelisib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have participated in a previous study of duvelisib, and:
• Be actively receiving duvelisib monotherapy on the previous study (within 14 days of study entry) and demonstrating clinical benefit (complete response \[CR\]/ partial response \[PR\]/ stable disease \[SD\]) of continued use, or
• Be in the survival follow-up phase of a previous duvelisib study
• Have completed the required components of the previous study and be appropriate for enrollment into this long-term continued treatment and follow-up study, as determined by the Sponsor

You may not qualify if:

• Had any ongoing ≥ Grade 3 adverse event (AE) considered related to duvelisib treatment at screening
• Was pregnant or nursing

Sponsors & Collaborators

• SecuraBio: lead

Study Sites (5)

Unknown Facility

Denver, Colorado, 80218, United States

Location

Unknown Facility

Sarasota, Florida, 34232, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Azienda Ospedaliera Santa Maria di Terni/SC Oncoematologia

Terni, Umbria, 05100, Italy

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

duvelisib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Beth Gregory, PharmD, MBA
• Organization: Secura Bio, Inc.

bgregory@securabio.com

1-702-254-0011

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2016
• First Posted: March 17, 2016
• Study Start: April 1, 2016
• Primary Completion: May 4, 2020
• Study Completion: May 4, 2020
• Last Updated: September 11, 2023
• Results First Posted: February 21, 2023

Record last verified: 2023-08

Locations

US (4); IT (1)