NCT02307240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2014

Longer than P75 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

4.6 years

First QC Date

November 18, 2014

Last Update Submit

August 30, 2019

Conditions

Triple-Negative Breast CancerHigh-grade Serous Ovarian CancerSolid TumorsNUT Midline Carcinoma

Keywords

TNBCHGSOCNMC

Outcome Measures

Primary Outcomes (1)

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

    21 day cycle

Secondary Outcomes (3)

  • 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

    24 months

Study Arms (1)

CUDC-907 - five days on/two days off

EXPERIMENTAL

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

Interventions

CUDC-907DRUG

CUDC-907 oral with meals.

CUDC-907 - five days on/two days off

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UCSF School of Medicine

San Francisco, California, 94143, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

CUDC-907

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2014

First Posted

December 4, 2014

Study Start

November 1, 2014

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

September 3, 2019

Record last verified: 2019-08

Locations

US(4)