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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 : Recruiting
First Posted : July 30, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Verastem, Inc.

Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 30, 2019
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE September 24, 2019
Estimated Primary Completion Date May 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
ORR (Objective Response Rate) [ Time Frame: 36 months ]
Proportion of subjects achieving a CR or PR will be estimated as per IWG Criteria.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04038359 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2019)
  • PFS (Progression Free Survival) [ Time Frame: 5 years ]
    From time of first dose of study intervention to PD or death.
  • 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
  • DOR (Duration of Response) [ Time Frame: 5 years ]
    From the time of first response to PD using KM methods.
  • OS (Overall Survival) [ Time Frame: 5 years ]
    From time of first dose of study intervention to death.
  • 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.
  • 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.
  • 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.
  • Peak Plasma Concentration (Cmax) [ Time Frame: 36 months ]
  • 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.
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: 36 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 2 Study Comparing 2 Intermittent Dosing Schedules of Duvelisib in Subjects With Indolent Non-Hodgkin Lymphoma. (TEMPO)
Official Title  ICMJE 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)
Brief Summary This study will examine the effects of predefined 2 week duvelisib dose holidays on tumor responses and safety/tolerability.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Indolent Non-hodgkin Lymphoma
Intervention  ICMJE Drug: Duvelisib
PI3K Inhibitor
Other Name: Copiktra, VS-0145
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Duvelisib
  • Experimental: Duvelisib, Intermittent Dosing
    Duvelisib 25 mg BID dosed two weeks on and two weeks off.
    Intervention: Drug: Duvelisib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 26, 2019)
102
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 29, 2024
Estimated Primary Completion Date May 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gloria Patrick 781-469-1594 gpatrick@verastem.com
Contact: Deborah Llyod 781-469-1583 dlloyd@verastem.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04038359
Other Study ID Numbers  ICMJE VS-0145-229
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Verastem, Inc.
Study Sponsor  ICMJE Verastem, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alena Zalutskaya, MD, PhD Verastem, Inc.
PRS Account Verastem, Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP