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

Primary Purpose

Triple-Negative Breast Cancer, High-grade Serous Ovarian Cancer, Solid Tumors

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CUDC-907

About this trial

This is an interventional treatment trial for Triple-Negative Breast Cancer focused on measuring TNBC, HGSOC, NMC

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 2.
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.

Sites / Locations

UCSF School of Medicine
Florida Cancer Specialists
Dana-Farber Cancer Institute
The University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CUDC-907 - five days on/two days off

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC).

To evaluate biomarkers of CUDC-907 activity

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

Full Information

NCT ID

NCT02307240

First Posted

November 18, 2014

Last Updated

August 30, 2019

Sponsor

Curis, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02307240

Brief Title

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

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

May 31, 2019 (Actual)

Study Completion Date

May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Curis, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

TNBC, HGSOC, NMC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CUDC-907 - five days on/two days off

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CUDC-907

Intervention Description

CUDC-907 oral with meals.

Primary Outcome Measure Information:

Title

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

Time Frame

21 day cycle

Secondary Outcome Measure Information:

Title

To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC).

Time Frame

21 day cycle

Title

To evaluate biomarkers of CUDC-907 activity

Time Frame

24 months

Title

To assess the preliminary anti-cancer activity of CUDC-907

Description

The Investigator will evaluate each subject for response to therapy according to standard response criteria for each individual subject's tumor type

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

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 2. 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.

Facility Information:

Facility Name

UCSF School of Medicine

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Florida Cancer Specialists

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34232

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

The University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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