Study of DCC-3014 in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

Overview

About this study

The purpose of this study is to evaluate the safety and tolerability of DCC-3014 in patients with solid tumors including, but not limited to, prostate, breast, gastric, ovarian, and non-small cell lung cancer, as well as tumor types with high macrophage content or high expression of CSF-1 such as tenosynovial giant cell tumor. There will be an Escalation Phase and an Expansion Phase in this study.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients ≥ 18 years of age.
  • Patients must have solid tumors 
  • Able to provide a tumor tissue sample.
  • Must have 1 measurable lesion according to RECIST Version 1.1.
  • Must have ECOG performance status of 0-1.
  • Adequate organ and bone marrow function.
  • If a female of childbearing potential, must have a negative pregnancy test prior to enrollment. 
  • Must provide signed consent to participate in the study and is willing to comply with study-specific procedures.

Exclusion Criteria:

  • Received anticancer therapy, therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with half-life longer than 3 days prior to the administration of study drug. 
  • Unresolved toxicity (> Grade 1 or baseline) from previous anticancer or TGCT therapy, excluding alopecia. 
  • Known active CNS metastases. 
  • History or presence of clinically relevant cardiovascular abnormalities. 
  • Systemic arterial or venous thrombotic or embolic events. 
  • QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or > 470 ms in females or history of long QT syndrome. 
  • Left ventricular ejection fraction (LVEF) < 50%. 
  • Concurrent treatment with proton-pump inhibitor. 
  • Major surgery within 2 weeks of the first dose of study drug. 
  • Malabsorption syndrome or other illness that could affect oral absorption. 
  • Known human immunodeficiency virus, active hepatitis B, active hepatitis C, or active mycobacterium tuberculosis infection. 
  • If female, the patient is pregnant or lactating.
  • Known allergy or hypersensitivity to any component of the study drug.
  • Any other clinically significant comorbidities.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Steven Attia, D.O.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20492350

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