Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss (NCT03435250) | Clinical Trial Compass
TerminatedPhase 1
Study of AG-270 in Participants With Advanced Solid Tumors or Lymphoma With MTAP Loss
Stopped: Strategic reasons
United States123 participantsStarted 2018-03-04
Plain-language summary
This study will evaluate the safety, pharmacokinetics, pharmacodynamics, and clinical activity of AG-270 in participants with advanced solid tumors or lymphoma with homozygous MTAP deletion.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Be ≥18 years of age;
✓. Have a histologically confirmed diagnosis of an advanced solid tumor or lymphoma that has progressed in spite of at least one prior line of treatment, and for which additional effective standard therapy is not available. For this study, effective standard therapy is defined as treatment that has been shown to be curative and/or to prolong survival. In addition, participants who are considered to not be candidates for standard therapy or who decline standard therapy are eligible for this study; in such cases, documentation of the reason for omitting or declining a standard therapy is required;
✓. Have evidence of homozygous loss of cyclin-dependent kinase inhibitor 2A (CDKN2A) and/or MTAP in the participant's tumor tissue;
✓. Have disease that can be clinically evaluated for improvement or progression. In the dose-expansion phase of the study arm, participants must have disease that is measurable, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria for solid tumors (Eisenhauer et al, 2009) or the Lugano criteria for lymphoma (Cheson et al, 2014);
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2;
✓. Have a hemoglobin ≥9.0 grams per deciliter (g/dL) without red blood cell transfusion for ≥1 month;
✓. Have an absolute neutrophil count (ANC) ≥1.0 × 10\^9/liter (L);
✓. Have a platelet count ≥75 × 10\^9/L;
Exclusion criteria
✕. Have a primary central nervous system (CNS) malignancy (eg, glioblastoma multiforme \[GBM\]);
What they're measuring
1
Percentage of Participants with DLTs Associated with AG-270 Administration During the First Cycle (First 28 Days) of Treatment
Timeframe: Up to 28 days, on average
2
Percentage of Participants with DLTs Associated with the Combination of AG-270 and Docetaxel Administration During the First Cycle (First 28 Days) of Treatment
Timeframe: Up to 28 days, on average
3
Percentage of Participants with DLTs Associated with the Combination of AG-270, nab-paclitaxel, and Gemcitabine Administration During the First Cycle (First 28 Days) of Treatment
Timeframe: Up to 28 days, on average
Trial details
NCT IDNCT03435250
SponsorInstitut de Recherches Internationales Servier
✕. Have metastasis to the CNS that is symptomatic and/or requires therapy with corticosteroids or anti-convulsant medication. However, participants who have completed treatment (radiation therapy) for CNS metastases and do not require continued treatment with corticosteroids or anti-convulsants may be enrolled in this study;
✕. Have a history of Gilbert's syndrome;
✕. Have a degenerative retinal disease. Retinal diseases that require a participant's exclusion include: glaucoma (with the exception of narrow angle glaucoma), hereditary retinal diseases such as retinitis pigmentosa; retinal arterial occlusive disease; and retinal disease with advanced scarring, to include age-related macular degeneration and myopic degeneration with geographic atrophy;
✕. Have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of AG-270, including any unresolved nausea, vomiting, or diarrhea that is National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade \>1;
✕. Have had significant active cardiac disease within 6 months prior to the start of study treatment, including any of the following:
✕. New York Heart Association (NYHA) class III or IV congestive heart failure;
✕. Acute myocardial infarction or angina pectoris;