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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Advanced Malignant Solid Neoplasm
  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IIIA Breast Cancer AJCC v8
  • Anatomic Stage IIIB Breast Cancer AJCC v8
  • Anatomic Stage IIIC Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Breast Neoplasms
  • Estrogen Receptor Negative
  • HER2/Neu Negative
  • Lymphoma
  • Metastatic Malignant Solid Neoplasm
  • Neoplasms
  • Pancreatic Ductal Adenocarcinoma
  • Pancreatic Neoplasms
  • Progesterone Receptor Negative
  • Prognostic Stage III Breast Cancer AJCC v8
  • Prognostic Stage IIIA Breast Cancer AJCC v8
  • Prognostic Stage IIIB Breast Cancer AJCC v8
  • Prognostic Stage IIIC Breast Cancer AJCC v8
  • Prognostic Stage IV Breast Cancer AJCC v8
  • Recurrent Lymphoma
  • Refractory Lymphoma
  • Stage II Pancreatic Cancer AJCC v8
  • Stage IIA Pancreatic Cancer AJCC v8
  • Stage IIB Pancreatic Cancer AJCC v8
  • Stage III Pancreatic Cancer AJCC v8
  • Stage IV Pancreatic Cancer AJCC v8
  • Triple-Negative Breast Carcinoma
  • Unresectable Solid Neoplasm

NCT number NCT03291938
Study type Interventional
Source M.D. Anderson Cancer Center
Contact
Status Completed
Phase Phase 1
Start date November 13, 2017
Completion date November 23, 2020

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