Summary

for people ages 16 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Pamela Munster

Description

Summary

This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors.

Official Title

Phase I Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of Orally Administered CUDC-907, an HDAC and PI3K Inhibitor, in Subjects With Advanced/Relapsed Solid Tumors

Details

This is a Phase I, open-label, multi-center trial designed to evaluate the safety, tolerability and pharmacokinetics of CUDC-907 administered orally to subjects with advanced/relapsed solid tumors. The following dosing schedule, consisting of 21-day treatment cycles, is being examined:

Five days on/two days off on Days 1 to 5, 8 to 12, and 15 to 19 (5/2 schedule).

Keywords

Triple-Negative Breast Cancer High-grade Serous Ovarian Cancer Solid Tumors NUT Midline Carcinoma TNBC HGSOC NMC Triple Negative Breast Neoplasms CUDC-907 CUDC-907 - five days on/two days off

Eligibility

You can join if…

Open to people ages 16 years and up

  1. Subjects ≥18 years of age for solid tumor; in the case of midline carcinoma with NUT rearrangement. subjects may be ≥16 years of age.
  2. Histopathologically confirmed diagnosis of an advanced solid tumor such as breast cancer or midline carcinoma with NUT rearrangement, that has progressed despite standard therapy, or for which no standard therapy exists. For enrollment in the expansion cohorts, histopathological confirmation of triple-negative breast cancer or high-grade serous ovarian cancer is required.
  3. Measurable or evaluable disease.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  5. Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments or radiotherapy (excluding alopecia).

You CAN'T join if...

  1. Systemic anticancer therapy within three weeks of study entry, except for nitrosoureas or mitomycin C within six weeks.
  2. Radiotherapy within one week prior to starting study treatment.
  3. Other investigational agent(s) within 21 days prior starting to study treatment.
  4. Symptomatic central nervous system (CNS) involvement or lymphangitic metastasis.Stable or improving CNS disease that is not under active treatment after receipt of adequate therapy is allowed.
  5. Uncontrolled or severe cardiovascular disease, including myocardial infarction or unstable angina within six months prior to study treatment, New York Heart Association(NYHA) Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease or cardiac amyloidosis.

Locations

  • UCSF School of Medicine accepting new patients
    San Francisco California 94143 United States
  • The University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Lead Scientist

  • Pamela Munster
    Professor, Medicine. Authored (or co-authored) 92 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Curis, Inc.
ID
NCT02307240
Phase
Phase 1
Study Type
Interventional
Last Updated