EUCTR2018-002896-17-GB
Active, not recruiting
Phase 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
ConditionsFollicular lymphoma (FL) or Marginal Zone Lymphoma (MZL)MedDRA version: 21.0Level: LLTClassification code 10029473Term: Nodular (follicular) lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Follicular lymphoma (FL) or Marginal Zone Lymphoma (MZL)
- Sponsor
- MEI Pharma, Inc.
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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,
Outcomes
Primary Outcomes
Not specified
Similar Trials
Unknown
Phase 2
A phase II trial to study the efficacy and safety of a new drug P276-00 in the treatment of Mantle Cell LymphomaHealth Condition 1: null- Mantle Cell LymphomaCTRI/2009/091/000771Piramal Life Sciences Limited25
Active, not recruiting
Phase 1
Phase 2, Open-label Single-Arm, Multi-Center Study to Evaluate the Efficacy and Safety of AMG 386 and Sorafenib as First Line Therapy for Subjects with Advanced or Inoperable Hepatocellular Carcinoma.advanced or inoperable hepatocellular carcinomaMedDRA version: 9.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableEUCTR2008-006212-38-FRAmgen Inc60
Active, not recruiting
Not Applicable
A Study of the Effectiveness and Safety of AMG 386 and Sorafenib to Treat Advanced or Inoperable Hepatocellular Canceradvanced or inoperable hepatocellular carcinomaMedDRA version: 17.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2008-006212-38-DEAmgen Inc60
Active, not recruiting
Phase 1
Phase 2 Open-Label Single-Arm, Multi-Center Study to Evaluate the Safety and Efficacy of Sunitinib Malate in Combination with AMG 386 as First Line or Second Line Therapy for Subjects with Metastatic Renal Cell CarcinomaMetastatic renal cell carcinomaMedDRA version: 9.1Level: LLTClassification code 10050513Term: Metastatic renal cell carcinomaEUCTR2008-006210-14-FRAmgen Inc85
Active, not recruiting
Phase 1
AMG 386 Phase 2 Open-Label Renal Cell Carcinoma (RCC) Study 1st Line or After Cytokine Failure in Combination With SunitinibMetastatic renal cell carcinomaMedDRA version: 17.0Level: PTClassification code 10050513Term: Metastatic renal cell carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2008-006210-14-BEAmgen Inc85