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Clinical Trials/EUCTR2018-002896-17-GB
EUCTR2018-002896-17-GBActive, not recruitingPhase 1

Multicenter, Open-Label, Single-Arm, Phase 2 Study of Zandelisib (ME401) in Subjects with Follicular Lymphoma or Marginal Zone LymphomaAfter Failure of Two or More Prior Systemic Therapies – The TIDAL Study

MEI Pharma, Inc.0 sites200 target enrollmentStarted: February 13, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
200
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Signed informed consent.
  • •2. Age =18 years (or age of majority).
  • •3. Histologically confirmed diagnosis as defined in the World Health
  • •Organization (WHO) classification (Swerdlow 2016) of:
  • •a. Follicular lymphoma (FL) limited to Grade 1, 2, or 3a; or
  • •b. Marginal zone lymphoma (MZL), including nodal, extranodal, and
  • •splenic MZL (histopathological report confirming diagnosis must be
  • •available during screening procedures).
  • •4. Subjects with relapsed or refractory FL or MZL who received =2 prior therapy regimens. A previous regimen is defined as one of the following:
  • •at least two months of single-agent therapy or at least two consecutive cycles of polychemotherapy, autologous transplant, or
  • •radioimmunotherapy. Prior therapy must include an anti-CD20
  • •monoclonal antibody (mAb) and an alkylating agent(s). Relapsed or
  • •refractory disease is defined as:
  • •a. Relapsed disease: disease progression after a response (CR or PR)
  • •lasting = 6 months
  • •b. Refractory disease: no response to therapy (no CR or PR), or response lasting <6 months
  • •5. At least one bi-dimensionally measurable nodal lesion >1.5 cm or
  • •extranodal lesions >1 cm in its longest diameter by computed
  • •tomography (CT) scan as defined by the Modified Lugano
  • •Classification(Appendix 5).
  • •a. Previously irradiated lesions can be selected as target lesions only in cases of unequivocal evidence of progression.
  • •b. For subjects with splenic MZL only: diffuse spleen involvement with splenomegaly, which is defined as the splenic vertical length greater than 13 cm.
  • •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (Oken 1982; Appendix 6).
  • •7. Adequate hematologic parameters at screening unless abnormal
  • •values are due to lymphoma per Investigator assessment:
  • •a. Absolute neutrophil count (ANC) =1.0 × 109/L (= 1,000/mm3)
  • •b. Platelet count =75.0 × 109/L (= 75,000/mm3)
  • •8. Adequate renal and hepatic function per local laboratory reference
  • •range at screening as follows:
  • •a. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic
  • •transaminase (SGOT), alanine aminotransferase (ALT)/serum glutamicpyruvate transaminase (SGPT) =3.0 × upper limit of normal(ULN)
  • •b. Total bilirubin =2.0 × ULN or =3 × ULN for subjects with Gilbert's
  • •c. Serum creatinine =1.5 × ULN or estimated glomerular filtration rate
  • •(eGFR) >50 mL/min using the Cockcroft-Gault equation (Appendix 2)
  • •9. QT-interval corrected according to Fridericia's formula (QTcF) =450
  • •milliseconds (msec); subjects with QTc >450 msec but <480 msec may
  • •be enrolled provided the QTc prolongation is due to a right bundle
  • •branch block (RBBB), left bundle branch block (LBBB), or pacemaker and is confirmed stable by a cardiologist.
  • •10. Left ventricular ejection fraction (LVEF) = 45% as measured by
  • •echocardiogram or multigated acquisition scan (MUGA). If LVEF <45%
  • •by ECHO, a repeat measurement can be conducted within the screening period.
  • •11. Subjects must have completed any prior systemic anti-cancer
  • •treatment within =4 weeks of Cycle 1 Day 1 (or =5 times the half-life
  • •[t½], whichever is longer); =8 weeks for antibody agents; =2 weeks for radiation therapy; and =3 months for high dose therapy with stem cell transplantation or CAR T cell therapy or radioimmunotherapy.
  • •12. All adverse events and laboratory toxicities related to prior therapy must resolve to Grade =1 prior to the start of the study therapy (unless otherwise specified in eligibility criteria).
  • •13. For females of childbearing potential, a negative serum human
  • •chorionic gonadotropin

Exclusion Criteria

  • •1. Histologically confirmed FL Grade 3b, or transformed disease
  • •(assessed by the Investigator):
  • •a. For patients with clinical (e.g., marked B-symptoms), laboratory (e.g., high lactate dehydrogenase [LDH]) or radiographic (e.g., high
  • •standardized uptake value by positron emission tomography [PET])
  • •signs of rapid disease progression, a fresh tumor biopsy prior to
  • •enrollment is required to rule out transformed disease
  • •2. Known lymphomatous involvement of the central nervous system.
  • •3. Major surgical procedure within 4 weeks prior to study Day 1 (minor surgical procedures, [e.g., lymph node biopsy] performed within 1 day or with an overnight stay are allowed).
  • •4. Prior therapy with PI3K inhibitors.
  • •5. Any uncontrolled clinically significant illness including, but not limited to, active infections requiring systemic antimicrobial therapy,
  • •hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction.
  • •6. Subjects who have tested positive for hepatitis B surface antigen
  • •and/or hepatitis B core antibody plus have a positive hepatitis B
  • •polymerase chain reaction (PCR) assay; subjects who have previously
  • •tested positive with a negative PCR assay are permitted with appropriate anti-viral prophylaxis.
  • •7. Positive hepatitis C virus antibody (HCV Ab); subjects with positive
  • •HCV Ab are eligible if they are negative for HCV by PCR.
  • •8. Known history of, or active human immunodeficiency virus (HIV)
  • •9. Ongoing or history of drug-induced pneumonitis.
  • •10. Previous or concurrent cancer that is distinct in primary site or
  • •histology from indolent B-cell NHL within 3 years before start of study
  • •treatment except for curatively treated cervical cancer in situ, nonmelanoma skin cancer, superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ], and T1 [tumor invades lamina propria]), and asymptomatic localized prostate cancer with no requirement for systemic therapy (or requiring only hormonal therapy) and with normal prostate-specific antigen values within =12 months prior to enrollment.
  • •11. History of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association classification = II [NYHA 1994]), myocardial infarction within 6 months of study entry.
  • •12. History of clinically significant gastrointestinal (GI) conditions,
  • •particularly:
  • •a. Known GI condition that would interfere with swallowing or the oral absorption or tolerance of study drug
  • •b. Pre-existing malabsorption syndrome or other clinical situation that would affect oral absorption
  • •13. Females who are pregnant; females who plan to breastfeed during study treatment through 90 days after ending treatment.
  • •14. Psychiatric illness/social situations that would interfere with study
  • •compliance.
  • •15. Hypersensitivity or other clinically significant reaction to the study drug or its inactive ingredients.
  • •16. Any other condition for which, in the opinion of the Investigator,
  • •participation would not be in the best interest of the subject.

Investigators

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