Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 in Subjects With Advanced/Relapsed Solid Tumors

Solid Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307240
• Other study ID #: CUDC-907-102
• Status: Completed
• Phase: Phase 1
• Start date: November 2014
• Est. completion date: May 31, 2019

Study information

• Verified date: August 2019
• Source: Curis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• High-grade Serous Ovarian Cancer
• NUT Midline Carcinoma
• Solid Tumors
• Triple Negative Breast Neoplasms
• Triple-Negative Breast Cancer

Intervention

Drug:
• CUDC-907
CUDC-907 oral with meals.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	UCSF School of Medicine	San Francisco	California
United States	Florida Cancer Specialists	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Curis, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors		21 day cycle
Secondary	To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC).		21 day cycle
Secondary	To evaluate biomarkers of CUDC-907 activity		24 months
Secondary	To assess the preliminary anti-cancer activity of CUDC-907	The Investigator will evaluate each subject for response to therapy according to standard response criteria for each individual subject's tumor type	24 months