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



Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/13/2018
Start Date:April 2016
End Date:December 2020

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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.

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.

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
We found this trial at
5
sites
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Nashville, TN
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Denver, CO
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Houston, Texas 77030
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Houston, TX
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Sarasota, FL
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1 Viale Tristano di Joannuccio
Terni, Umbria 05100
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Terni,
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