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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

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ClinicalTrials.gov Identifier: NCT02307240
Recruitment Status : Recruiting
First Posted : December 4, 2014
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Curis, Inc.

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.

Condition or disease Intervention/treatment Phase
Triple-Negative Breast Cancer High-grade Serous Ovarian Cancer Solid Tumors NUT Midline Carcinoma Drug: CUDC-907 Phase 1

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


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.




Primary Outcome Measures :
  1. To determine the safety and tolerability of oral CUDC-907 in subjects with advanced/relapsed solid tumors [ Time Frame: 21 day cycle ]

Secondary Outcome Measures :
  1. To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC). [ Time Frame: 21 day cycle ]
  2. To evaluate biomarkers of CUDC-907 activity [ Time Frame: 24 months ]
  3. To assess the preliminary anti-cancer activity of CUDC-907 [ Time Frame: 24 months ]
    The Investigator will evaluate each subject for response to therapy according to standard response criteria for each individual subject's tumor type



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307240


Contacts
Contact: David Tuck, MD clinicaltrials@curis.com

Locations
United States, California
UCSF School of Medicine Recruiting
San Francisco, California, United States, 94143
United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 34232
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Curis, Inc.

Responsible Party: Curis, Inc.
ClinicalTrials.gov Identifier: NCT02307240     History of Changes
Other Study ID Numbers: CUDC-907-102
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2017

Keywords provided by Curis, Inc.:
TNBC
HGSOC
NMC

Additional relevant MeSH terms:
Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases