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A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma. (TEMPO)

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ClinicalTrials.gov Identifier: NCT04038359
Recruitment Status : Not yet recruiting
First Posted : July 30, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

Brief Summary:
This study will examine the effects of predefined 2 week duvelisib dose holidays on tumor responses and safety/tolerability.

Condition or disease Intervention/treatment Phase
Indolent Non-hodgkin Lymphoma Drug: Duvelisib Phase 2

Detailed Description:
This is a Phase 2, randomized, open-label, 2 arm study designed to evaluate the efficacy and safety of prescribed drug holidays of duvelisib treatment in subjects with R/R iNHL who have received at least 1 prior systemic therapy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Open-label, 2-Arm Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non Hodgkin Lymphoma (iNHL) (TEMPO)
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : July 29, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Gelusil

Arm Intervention/treatment
Experimental: Duvelisib, Continuous and Intermittent Dosing
Duvelisib 25 mg BID continuously for 10 weeks, followed by 25 mg BID dosed two weeks on and two weeks off of each subsequent 4-week cycles.
Drug: Duvelisib
PI3K Inhibitor
Other Name: Copiktra, VS-0145

Experimental: Duvelisib, Intermittent Dosing
Duvelisib 25 mg BID dosed two weeks on and two weeks off.
Drug: Duvelisib
PI3K Inhibitor
Other Name: Copiktra, VS-0145




Primary Outcome Measures :
  1. ORR (Objective Response Rate) [ Time Frame: 36 months ]
    Proportion of subjects achieving a CR or PR will be estimated as per IWG Criteria.


Secondary Outcome Measures :
  1. PFS (Progression Free Survival) [ Time Frame: 5 years ]
    From time of first dose of study intervention to PD or death.

  2. ORR (Objective Response Rate) [ Time Frame: ORR estimated at 6, 12, 18, and 24 months after first dose of study intervention. ]
    Proportion of subjects achieving a CR or PR will be estimated as per Lugano Criteria

  3. DOR (Duration of Response) [ Time Frame: 5 years ]
    From the time of first response to PD using KM methods.

  4. OS (Overall Survival) [ Time Frame: 5 years ]
    From time of first dose of study intervention to death.

  5. LNRR (Lymph Node Response Rate) [ Time Frame: 36 months ]
    LNRR will be calculated as the proportion of subjects achieving ≥ 50% decrease in the SPD of target lymph nodes.

  6. TTFR (Time To First Relapse) [ Time Frame: 36 months ]
    From the time of first dose of study intervention to time of first CR or PR.

  7. Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: 36 months ]
    From the time of screening to the end of Safety Follow-Up period of the study.

  8. Peak Plasma Concentration (Cmax) [ Time Frame: 36 months ]
  9. TTF (Time To Treatment Failure) [ Time Frame: 5 years ]
    From first dose of study intervention until discontinuation for any reason and will be summarized using KM methods.

  10. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 36 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years, ECOG performance status ≤ 2
  • Histologically confirmed diagnosis of iNHL (Subtypes include FL Grades 1 to 3a, marginal zone lymphoma (splenic, nodal, or extranodal), or SLL
  • Must have received 1 prior systemic regimen for iNHL
  • Must have documented radiologic evidence of disease progression, and at least 1 bi-dimensionally measurable lesion ≥ 1.5 cm (which has not been previously irradiated), according to 2007 revised IWG criteria
  • Must have adequate organ function defined by the following laboratory parameters:

    • Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L
    • Platelet count ≥ 75 × 10^9/L
    • Serum creatinine < 2.0 mg/dL (197 µmol/L)
    • Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (exception: subjects with Gilbert's Syndrome may have a bilirubin > 1.5 × ULN)
    • Aspartate transaminase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum pyruvic transaminase (SGPT) ≤ 3.0 × ULN

Exclusion Criteria:

  • Anticancer treatment, major surgery, or use of any investigational drug within 28 days before the start of study intervention; palliative radiation therapy is allowed if > 7 days and any toxicity is Grade ≤ 1
  • Clinical or histological evidence of transformation to a more aggressive subtype of lymphoma or grade 3b FL or Richters' transformation or CLL
  • Prior allogeneic hematopoietic stem cell transplant (HSCT); treatment with a PI3K inhibitor
  • History of drug-induced colitis or pneumonitis; TB treatment ≤ 2 years prior to randomization; administration of a live or live attenuated vaccine within 6 weeks of randomization
  • Ongoing treatment with chronic immunosuppressants or systemic steroids or treatment for systemic bacterial, fungal, or viral infection
  • Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection
  • Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
  • Concurrent administration of medications or foods that are strong inhibitors or inducers of cytochrome P450 3A (CYP3A). No prior use within 2 weeks before the start of study intervention.
  • Baseline QTcF > 500 ms
  • Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix, bladder cancer, or prostate cancer not requiring treatment. Subjects with previous malignancies are eligible if they have been disease-free for 2 years or more.
  • Unstable or severe uncontrolled medical condition that would, in the Investigator's judgment, increase the subject's risk to participating in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038359


Contacts
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Contact: Gloria Patrick 781-469-1594 gpatrick@verastem.com
Contact: Deborah Llyod 781-469-1583 dlloyd@verastem.com

Sponsors and Collaborators
Verastem, Inc.
Investigators
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Study Director: Alena Zalutskaya, MD, PhD Verastem, Inc.

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Responsible Party: Verastem, Inc.
ClinicalTrials.gov Identifier: NCT04038359     History of Changes
Other Study ID Numbers: VS-0145-229
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Verastem, Inc.:
PI3K Inhibitor
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
TEMPO
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs