IACS-010759 in Advanced Cancers (NCT03291938) | Clinical Trial Compass
CompletedPhase 1
IACS-010759 in Advanced Cancers
United States29 participantsStarted 2017-11-13
Plain-language summary
This phase I trial studies the side effects and best dose of oxidative phosphorylation inhibitor IACS-010759 (IACS-010759) in treating patients with lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or solid tumors that have spread to other places in the body (advanced/metastatic) or cannot be removed by surgery (unresectable). IACS-010759 may stop the growth of cancer or tumor cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Non-pregnant.
* Subjects must have histologically confirmed malignancy that is metastatic or unresectable and for which there is no available therapy likely to convey clinical benefit.
* Subjects must have received at least one line of systemic therapy in the advanced/metastatic setting. Subjects with diseases without known effective options are also eligible. a) Subjects with relapsed and/or refractory lymphoma must have had at least 2 prior lines of systemic therapy and are not candidates for high dose therapy/autologous stem cell transplant.
* Subjects must have evaluable disease for the dose escalation, and measurable disease for the dose expansion.
* Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
* Subjects must have a life expectancy \>= 12 weeks.
* Absolute neutrophil count \>= 1,500/mcL.
* Hemoglobin \>= 9 g/dL.
* Platelets \>= 100,000/mcL.
* Total bilirubin =\< 1.5 x the institutional upper limit of normal (ULN).
* Aspartate transaminase (AST) serum glutamic oxaloacetic transaminase (SGOT)/alanine transaminase (ALT) serum glutamic pyruvic transaminase (SGPT) =\< 2.5 x institutional ULN or =\< 5 x institutional ULN in the presence of liver metastases.
* Creatinine clearance \>= 45 mL/min/1.73 m\^2 for subjects with creatinine levels above institutional normal.
* Women of childbearing potential (WOCBP) must agree to use an adequate method of contraception during the study and until 3 months after the…