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

Sponsor
SecuraBio (Industry)
Overall Status
Completed
CT.gov ID
NCT02711852
Collaborator
(none)
19
Enrollment
5
Locations
1
Arm
49.1
Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This long-term, continued treatment study will evaluate the long-term safety of duvelisib in patients with hematologic malignancies that were previously treated with duvelisib in a previous sponsor-approved study.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Study IPI-145-23 is an international, multicenter, open-label, single-arm, Phase 2 study designed to evaluate the long-term safety, clinical activity and overall survival data of duvelisib in patients with hematologic malignancies. Only subjects who have participated in a previous duvelisib study that are approved by the sponsor will be allowed to enroll in the study.

Enrollment is undetermined as multiple duvelisib studies are allowed to rollover active subjects with Verastem's approval. Subjects in active treatment and subjects in survival follow-up are allowed to rollover to this study. For subjects on active treatment, subjects will continue the same dose from their previous duvelisib study and will take duvelisib twice daily (BID) for 28 day continuous cycles until disease progression or unacceptable toxicity. For subjects in survival follow-up, subjects will continue to be followed for survival in this study for the duration outlined in their previous duvelisib study.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Long-term, Continued Treatment and Follow-up Study in Subjects With Hematologic Malignancies Treated With Duvelisib (IPI-145)
Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
May 4, 2020
Actual Study Completion Date :
May 4, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Drug: Duvelisib (IPI-145)

Subjects will begin taking the same dose from their previous duvelisib study. All doses are taken by mouth twice daily (BID). Two dose reductions are allowed per subject, but doses may not be less than 10 mg.

Drug: Duvelisib
Subjects will begin taking the same dose from their previous duvelisib study. All doses are taken by mouth twice daily (BID). Two dose reductions are allowed per subject, but doses may not be less than 10 mg. Subjects will take duvelisib until disease progression or unacceptable toxicity.
Other Names:
  • IPI-145

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse Events (AEs) and safety laboratory test values [Every 3 cycles until study completion, an average of 18 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:
    • Subjects actively receiving duvelisib are to be excluded from this study if they have any ongoing ≥ Grade 3 AE considered related to duvelisib treatment at screening

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Denver Colorado United States 80218
    2 Sarasota Florida United States 34232
    3 Nashville Tennessee United States 37203
    4 UT MD Anderson Cancer Center Houston Texas United States 77030
    5 Azienda Ospedaliera Santa Maria di Terni/SC Oncoematologia Terni Umbria Italy 05100

    Sponsors and Collaborators

    • SecuraBio

    Investigators

    • Study Director: David Cohan, MD, SecuraBio

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SecuraBio
    ClinicalTrials.gov Identifier:
    NCT02711852
    Other Study ID Numbers:
    • IPI-145-23
    First Posted:
    Mar 17, 2016
    Last Update Posted:
    Mar 17, 2021
    Last Verified:
    Mar 1, 2021
    Additional relevant MeSH terms:
    Neoplasms
    Hematologic Neoplasms

    Study Results

    No Results Posted as of Mar 17, 2021