Open Label, Multi-center Study to Assess the Safety, Tolerability and Pharmacokinetics of CUDC-907 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.
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. The following dosing schedules may be examined, each consisting of 21-day treatment cycles:
- Three days weekly on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 (TIW schedule).
- Five days on/two days off on Days 1 to 5, 8 to 12, and 15 to 19 (5/2 schedule).
- Four days on/three days off on Days 1 to 4, 8 to 11, and 15 to 18 (4/3 schedule).
NUT Midline Carcinoma Breast Cancer Solid Tumors NMC
You can join if…
Open to people ages 18 years and up
- Subjects ≥18 years of age
- 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
- 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). Note: for subjects with HR+/Her2 negative breast cancer only: ongoing treatment with any of the following: tamoxifen, anastrozole,exemestane or letrozole is allowed
- 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)
- For subjects with diabetes, adequate blood sugar control as evidenced by a hemoglobin A1c value <8%
- Women of child-bearing potential must have a negative serum or urine pregnancy test
- 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
- Able to provide written informed consent and follow protocol requirements
You CAN'T join 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
- Diabetes mellitus uncontrolled by medication
- Ongoing diarrhoea defined as more than one watery stool/day
- Serious infection requiring systemic antibiotic therapy within 14 days prior to study treatment
- 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
- Second primary malignancy within two years of study entry that requires active treatment
- Known gastrointestinal condition that would interfere with swallowing or oral absorption/tolerance of CUDC-907
- Known positive status for human immunodeficiency virus (HIV) or hepatitis B surface antigen, or known or suspected hepatitis C infection
- Pregnancy or ongoing breast-feeding status
- 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
- UCSF School of Medicine accepting new patients
San Francisco, California, 94143, United States
- The University of Texas MD Anderson Cancer Center accepting new patients
Houston, Texas, 77030, United States
- Florida Cancer Specialists accepting new patients
Sarasota, Florida, 34232, United States
- Dana-Farber Cancer Institute accepting new patients
Boston, Massachusetts, 02215, United States
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02307240.