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

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

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.

Study Overview

• Status: Completed
• Conditions: High-grade Serous Ovarian Cancer; Solid Tumors; Triple-Negative Breast Cancer; NUT Midline Carcinoma
• Intervention / Treatment: Drug: CUDC-907

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).

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF School of Medicine
  • Florida
    • Sarasota, Florida, United States, 34232
      • Florida Cancer Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: CUDC-907; CUDC-907 oral with meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors	21 day cycle

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC).		21 day cycle
To evaluate biomarkers of CUDC-907 activity		24 months
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

Collaborators and Investigators

• Sponsor: Curis, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: November 18, 2014
• First Submitted That Met QC Criteria: December 1, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Actual): September 3, 2019
• Last Update Submitted That Met QC Criteria: August 30, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: TNBC; HGSOC; NMC
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: CUDC-907-102