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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

This study is currently recruiting participants.
Verified November 2016 by Curis, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02307240
First Posted: December 4, 2014
Last Update Posted: November 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Curis, Inc.
  Purpose
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 Intervention Phase
NUT Midline Carcinoma Breast Cancer Solid Tumors Drug: CUDC-907 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel 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

Resource links provided by NLM:


Further study details as provided by Curis, Inc.:

Primary Outcome Measures:
  • To establish the maximum tolerated dose/biologically effective dose (MTD/BED) and recommended Phase 2 dose (RP2D) of CUDC-907 [ Time Frame: 21 day cycle ]

Secondary Outcome Measures:
  • To assess the pharmacokinetics (PK) of CUDC-907; Pharmacokinetic parameters will include area under the concentration-time curve (AUC). [ Time Frame: 21 day cycle ]
  • To assess the safety and tolerability of CUDC-907; Number of participants with adverse events assessed using the NCI Common Terminology Criteria for Adverse Events [ Time Frame: 18 months ]
  • 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


Estimated Enrollment: 60
Study Start Date: November 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CUDC-907 - 3x/week (TIW)
120 -150 mg/day CUDC-907, oral administration, three days weekly until disease progression or other discontinuation criteria are met.
Drug: CUDC-907
CUDC-907 oral with meals.
Experimental: CUDC-907 - five days on/two days off
60 -90 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.
Experimental: CUDC-907 four days on/three days off
60 -90 mg/day CUDC-907, oral administration, four days on/three days off until disease progression or other discontinuation criteria are met.
Drug: CUDC-907
CUDC-907 oral with meals.

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 schedules may be examined, each consisting of 21-day treatment cycles:

  1. Three days weekly on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 (TIW schedule).
  2. Five days on/two days off on Days 1 to 5, 8 to 12, and 15 to 19 (5/2 schedule).

3. Four days on/three days off on Days 1 to 4, 8 to 11, and 15 to 18 (4/3 schedule).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects ≥18 years of age
  2. Histopathologically confirmed diagnosis of 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. In the case of breast cancer, this must be ER+ or PR+, Her2 negative disease (women only) with disease progression on at least one prior hormonal therapy for advanced/metastatic disease or disease relapse while on adjuvant hormonal therapy
  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). Note: for subjects with HR+/Her2 negative breast cancer only: ongoing treatment with any of the following: tamoxifen, anastrozole, exemestane or letrozole is allowed
  6. Adequate hematologic and organ function as evidenced by the following laboratory studies within two weeks (14 days) of study enrollment: Absolute neutrophil count 1,500/L; platelets 100,000/L; hemoglobin >9 g/dL; creatinine 1.5x upper limit of normal (ULN); total bilirubin (Tbili) 1.5x ULN; aspartate aminotransferase/alanine aminotransferase (AST/ALT) 2.5x ULN; serum albumin >3 g/dl; partial thromboplastin time or INR <1.2 x ULN (unless receiving therapeutic anticoagulation)
  7. For subjects with diabetes, adequate blood sugar control as evidenced by a hemoglobin A1c value <8%
  8. Women of child-bearing potential must have a negative serum or urine pregnancy test
  9. Men and women of child-bearing potential must agree to use adequate birth control throughout their participation in the study and for 30 days following the last study treatment
  10. Able to provide written informed consent and follow protocol requirements

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
  6. Diabetes mellitus uncontrolled by medication
  7. Ongoing diarrhoea defined as more than one watery stool/day
  8. Serious infection requiring systemic antibiotic therapy within 14 days prior to study treatment
  9. Immunosuppressive medication within 7 days prior to first dose of CUDC-907. Inhaled and topical corticosteroids are permitted, as is replacement dosing of steroids (defined as <30 mg/day hydrocortisone or the equivalent) provided that the subject has been on a stable or tapering dose for at least 14 days prior to the first dose of CUDC-907
  10. Second primary malignancy within two years of study entry that requires active treatment
  11. Known gastrointestinal condition that would interfere with swallowing or oral absorption/tolerance of CUDC-907
  12. Known positive status for human immunodeficiency virus (HIV) or hepatitis B surface antigen, or known or suspected hepatitis C infection
  13. Pregnancy or ongoing breast-feeding status
  14. Unstable or clinically significant concurrent condition (e.g. medical or psychological) that would, in the opinion of the investigator, jeopardize subject safety and/or compliance with the protocol
  Contacts and Locations
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: Amir Hafeez, 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.
  More Information

Responsible Party: Curis, Inc.
ClinicalTrials.gov Identifier: NCT02307240     History of Changes
Other Study ID Numbers: CUDC-907-102
First Submitted: November 18, 2014
First Posted: December 4, 2014
Last Update Posted: November 25, 2016
Last Verified: November 2016

Keywords provided by Curis, Inc.:
NMC