Clinical Trials Directory

Trials / Completed

CompletedNCT03291938

IACS-010759 in Advanced Cancers

A Phase 1 Study to Evaluate the Safety and Tolerability of IACS-010759 in Subjects With Advanced Solid Tumors and Lymphoma

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
29 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of IACS-010759, the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) in subjects with any advanced solid tumor and lymphoma. SECONDARY OBJECTIVES: I. To evaluate IACS-010759 pharmacokinetics and preliminary antitumor activity (including overall response rate and duration of response). EXPLORATORY OBJECTIVES: I. To evaluate pharmacodynamic and exploratory predictive biomarkers of activity of IACS-010759. OUTLINE: This is a dose-escalation study. INDUCTION PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 orally (PO) once daily (QD) on days 1-7 of cycle 1 in the absence of disease progression or unacceptable toxicity. MAINTENANCE PHASE: Patients receive oxidative phosphorylation inhibitor IACS-010759 PO QD on days 8 and 15 of cycle 1 and then on days 1, 8, and 15 of subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3-6 months for up to 2 years.

Conditions

Interventions

TypeNameDescription
DRUGOxidative Phosphorylation Inhibitor IACS-010759Given PO
OTHERPharmacodynamic StudyCorrelative studies
OTHERPharmacokinetic StudyCorrelative studies

Timeline

Start date
2017-11-13
Primary completion
2020-11-23
Completion
2020-11-23
First posted
2017-09-25
Last updated
2020-11-24

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT03291938. Inclusion in this directory is not an endorsement.