Clinical trial NCT02307240: Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Triple-Negative Breast Cancer
High-grade Serous Ovarian Cancer
Solid Tumors
NUT Midline Carcinoma
Keywords: TNBC
HGSOC
NMC
Lead sponsor: Curis, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 43
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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).

Eligibility criteria: Inclusion Criteria:

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).

Exclusion Criteria:

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.

Primary outcomes:
measure: To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors
timeFrame: 21 day cycle
Secondary outcomes:
measure: To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC).
timeFrame: 21 day cycle
measure: To evaluate biomarkers of CUDC-907 activity
timeFrame: 24 months
measure: To assess the preliminary anti-cancer activity of CUDC-907
timeFrame: 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF School of Medicine
state: California
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References: