Status:
COMPLETED
Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors
Lead Sponsor:
Curis, Inc.
Conditions:
Triple-Negative Breast Cancer
High-grade Serous Ovarian Cancer
Eligibility:
All Genders
16+ years
Phase:
PHASE1
Brief 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.
Detailed Description
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. Th...
Eligibility Criteria
Inclusion
- Subjects ≥18 years of age for solid tumor; in the case of midline carcinoma with NUT rearrangement. subjects may be ≥16 years of age.
- 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.
- Measurable or evaluable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments or radiotherapy (excluding alopecia).
Exclusion
- Systemic anticancer therapy within three weeks of study entry, except for nitrosoureas or mitomycin C within six weeks.
- Radiotherapy within one week prior to starting study treatment.
- Other investigational agent(s) within 21 days prior starting to study treatment.
- 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.
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2019
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02307240
Start Date
November 1 2014
End Date
May 31 2019
Last Update
September 3 2019
Active Locations (4)
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1
UCSF School of Medicine
San Francisco, California, United States, 94143
2
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030