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

Curis, Inc.4 sites in 1 country43 target enrollmentNovember 2014

ConditionsTriple-Negative Breast Cancer High-grade Serous Ovarian Cancer Solid Tumors NUT Midline Carcinoma

InterventionsCUDC-907

DrugsCUDC-907

Overview

Phase: Phase 1
Intervention: CUDC-907
Conditions: Triple-Negative Breast Cancer
Sponsor: Curis, Inc.
Enrollment: 43
Locations: 4
Primary Endpoint: To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

May 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Curis, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•Recovery to Grade 1 or baseline of any toxicity due to prior systemic treatments or radiotherapy (excluding alopecia).

Exclusion Criteria

•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.

Arms & Interventions

CUDC-907 - five days on/two days off

60 mg/day CUDC-907, oral administration, five days on/two days off until disease progression or other discontinuation criteria are met.

Intervention: CUDC-907

Outcomes

Primary Outcomes

To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors

Time Frame: 21 day cycle

Secondary Outcomes

To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC).(21 day cycle)
To assess the preliminary anti-cancer activity of CUDC-907(24 months)
To evaluate biomarkers of CUDC-907 activity(24 months)