Hematologic MalignanciesPhase 1NCT01476657
A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies
A Phase 1 study testing IPI-145 (duvelisib) in people with Hematologic Malignancies, run by SecuraBio at 4 sites in United States.
Trial summary
The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- IPI-145 (duvelisib)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2011to Jan 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age;
- Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease with no established therapy with the exception of expansion cohort of treatment naïve CLL patients;
- An Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.
Who cannot join
- Any previous treatment with a PI3K inhibitor (Escalation Phase only) or within 4 weeks of the start of IPI-145 administration (Expansion Phase);
- Patients with overt leptomeningeal leukemia or CNS lymphoma;
- Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN); direct bilirubin >1.5 x ULN;
- Inadequate renal function defined by serum creatinine > 1.5 x ULN
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Columbus, Ohio, 43210
Study site
Houston, Texas, 77030
Study site
Nashville, Tennessee, 37203
Study site
New York, New York, 10065
About this study
The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.
- Conditions
- Hematologic Malignancies
- Being tested
- IPI-145 (duvelisib)
- Keywords
- Phase 1
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPI-145 (duvelisib)Drug
Oral Twice A Day (BID) Dosing
| Study group | Role | What they receive |
|---|---|---|
| IPI-145 | Experimental | IPI-145 is administered orally as a capsule formulation. The IPI-145 drug product is supplied as 1 mg, 5 mg, 25 mg, and 100 mg formulated capsules. IPI-145 will be administered orally daily during each 28-day cycle. Patients will be evaluated for DLTs in the dose escalation portion of the study during Cycle 1 (28 days), after which treatment may continue for additional cycles. Receives: Drug: IPI-145 (duvelisib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
To determine the incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities.
Measured: At least 28 days (1 Cycle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2016
- Study completionJan 2017
Why it stopped: The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- SecuraBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hagop Youssoufian, MD, Study chair, Verastem, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476657
- Sponsor's protocol ID
- IPI-145-02
- Status last verified
- Mar 2021
- First submitted
- 17 Nov 2011
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Horwitz SM, Koch R, Porcu P, Oki Y, Moskowitz A, Perez M, Myskowski P, Officer A, Jaffe JD, Morrow SN, Allen K, Douglas M, Stern H, Sweeney J, Kelly P, Kelly V, Aster JC, Weaver D, Foss FM, Weinstock DM. Activity of the PI3K-delta,gamma inhibitor duvelisib in a phase 1 trial and preclinical models of T-cell lymphoma. Blood. 2018 Feb 22;131(8):888-898. doi: 10.1182/blood-2017-08-802470. Epub 2017 Dec 12.
PubMed 29233821Flinn IW, O'Brien S, Kahl B, Patel M, Oki Y, Foss FF, Porcu P, Jones J, Burger JA, Jain N, Kelly VM, Allen K, Douglas M, Sweeney J, Kelly P, Horwitz S. Duvelisib, a novel oral dual inhibitor of PI3K-delta,gamma, is clinically active in advanced hematologic malignancies. Blood. 2018 Feb 22;131(8):877-887. doi: 10.1182/blood-2017-05-786566. Epub 2017 Nov 30.
PubMed 29191916Patel VM, Balakrishnan K, Douglas M, Tibbitts T, Xu EY, Kutok JL, Ayers M, Sarkar A, Guerrieri R, Wierda WG, O'Brien S, Jain N, Stern HM, Gandhi V. Duvelisib treatment is associated with altered expression of apoptotic regulators that helps in sensitization of chronic lymphocytic leukemia cells to venetoclax (ABT-199). Leukemia. 2017 Sep;31(9):1872-1881. doi: 10.1038/leu.2016.382. Epub 2016 Dec 26.
PubMed 28017967
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Duvelisib in Patients With Advanced Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT01476657
- Acronym / sponsor ID
- IPI-145-02
- Conditions
- Hematologic Malignancies
- Keywords
- Phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.
- Enrolment
- 210 participants (actual)
- Lead sponsor
- SecuraBioIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, maximum tolerated dose and pharmacokinetics of IPI-145 in patients with advanced hematologic malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IPI-145 | Experimental | Drug: IPI-145 (duvelisib)IPI-145 is administered orally as a capsule formulation. The IPI-145 drug product is supplied as 1 mg, 5 mg, 25 mg, and 100 mg formulated capsules. IPI-145 will be administered orally daily during each 28-day cycle. Patients will be evaluated for DLTs in the dose escalation portion of the study during Cycle 1 (28 days), after which treatment may continue for additional cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years of age;
- Progressed during, refractory to, intolerant of, or ineligible for established therapy, or has a disease with no established therapy with the exception of expansion cohort of treatment naïve CLL patients;
- An Eastern Cooperative Oncology Group (ECOG) score of 0 to 2.
Key exclusion criteria (4 listed)
- Any previous treatment with a PI3K inhibitor (Escalation Phase only) or within 4 weeks of the start of IPI-145 administration (Expansion Phase);
- Patients with overt leptomeningeal leukemia or CNS lymphoma;
- Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN); direct bilirubin >1.5 x ULN;
- Inadequate renal function defined by serum creatinine > 1.5 x ULN
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPI-145 (duvelisib)Oral Twice A Day (BID) Dosing | Drug | IPI-145 |
Primary outcome
Safety and Tolerability
Time frame: At least 28 days (1 Cycle)
To determine the incidence of adverse events and abnormal laboratory test results, including dose-limiting toxicities.
Results and safety
The study was stopped early (reason given: The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 29233821Horwitz SM, Koch R, Porcu P, Oki Y, Moskowitz A, Perez M, Myskowski P, Officer A, Jaffe JD, Morrow SN, Allen K, Douglas M, Stern H, Sweeney J, Kelly P, Kelly V, Aster JC, Weaver D, Foss FM, Weinstock DM. Activity of the PI3K-delta,gamma inhibitor duvelisib in a phase 1 trial and preclinical models of T-cell lymphoma. Blood. 2018 Feb 22;131(8):888-898. doi: 10.1182/blood-2017-08-802470. Epub 2017 Dec 12.
- Derived from this study: PubMed 29191916Flinn IW, O'Brien S, Kahl B, Patel M, Oki Y, Foss FF, Porcu P, Jones J, Burger JA, Jain N, Kelly VM, Allen K, Douglas M, Sweeney J, Kelly P, Horwitz S. Duvelisib, a novel oral dual inhibitor of PI3K-delta,gamma, is clinically active in advanced hematologic malignancies. Blood. 2018 Feb 22;131(8):877-887. doi: 10.1182/blood-2017-05-786566. Epub 2017 Nov 30.
- Derived from this study: PubMed 28017967Patel VM, Balakrishnan K, Douglas M, Tibbitts T, Xu EY, Kutok JL, Ayers M, Sarkar A, Guerrieri R, Wierda WG, O'Brien S, Jain N, Stern HM, Gandhi V. Duvelisib treatment is associated with altered expression of apoptotic regulators that helps in sensitization of chronic lymphocytic leukemia cells to venetoclax (ABT-199). Leukemia. 2017 Sep;31(9):1872-1881. doi: 10.1038/leu.2016.382. Epub 2016 Dec 26.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hagop Youssoufian, MD study chair
Verastem, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IPI-145 (duvelisib) in people with Hematologic Malignancies, run by SecuraBio at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The scope of the program has been reduced to focus resources on studies which can potentially enable the registration of duvelisib.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: At least 28 days (1 Cycle)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01476657, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.