Status:
COMPLETED
STAT3 Inhibitor for Solid Tumors
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Advanced Cancer
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find the highest tolerable dose of OPB-31121 that can be given to patients with an advanced solid tumor. The safety of this drug will also be studied.
Detailed Description
The Study Drug: OPB-31121 is designed to block certain proteins in cancer cells that cause the cancer cells to reproduce and form more cancer cells. Study Groups: If you are found to be eligible to...
Eligibility Criteria
Inclusion
- Subjects with histologically or radiologically confirmed solid tumors refractory to standard therapy, for which there is no standard therapy, or are not eligible for standard therapy. Subjects must have at least one measurable lesion.
- Male and female subjects \>/= 18 years of age.
- Male and female subjects who are surgically sterile; female subjects who have been postmenopausal for at least 12 consecutive months; or male and female subjects who agree to remain abstinent or to begin TWO acceptable methods of birth control from one week prior to drug administration through 30 days (for females) and 90 days (for males) from the last dose of study medication. If employing birth control, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device (IUD), condom, diaphragm, cervical cap or sponge with spermicide.
- Eastern Cooperative Oncology Group (ECOG) performance status: \</= 2
- Subjects must have a life expectancy of longer than 3 months.
- Adequate vital organ function as follows: Neutrophils: \>/= 1,500/microliter; platelets: \>/= 75,000/microliter; hemoglobin: \>/= 9.0 g/dL; Aspartate transaminase (AST), Alanine transaminase (ALT): \</= 2.5 \* ULN with the exception of subjects with liver metastases. In these cases, AST, ALT \</= 5 \* ULN for eligibility; serum total bilirubin: \< 2.5 \* ULN. Subjects must have a normal serum creatinine with a measured 24 hour creatinine clearance of \> 60 cc/min; INR \< 1.5
- Ability to provide written informed consent prior to initiation of any study-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the study.
- Subjects, who have received prior therapy, eg, chemotherapy, radiotherapy, or surgery, must have stopped therapy for \>/= 4 weeks prior to drug administration. Subjects who have received targeted or immunotherapy must have stopped therapy for 5 half lives or 4 weeks prior to drug administration, whichever is earlier, and recovered from any prior toxicity not mentioned above to at least Grade 1.
- Subjects must have a normal ejection fraction (\>/= 50%) as measured by either echocardiogram or multi gated acquisition (MUGA) scan.
Exclusion
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known central nervous system (CNS) metastasis.
- Presence of active gastrointestinal disease or other condition (eg, significant bowel resections) which has the potential to significantly affect the absorption of the study drug, in the opinion of the investigator or sponsor.
- Known history of or concurrent hepatitis or acquired immunodeficiency syndrome (AIDS) or known carriers of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies (anti-HCV), or human immunodeficiency virus (HIV) antibodies.
- Subjects who are pregnant or breast feeding. A negative urine pregnancy test must be confirmed prior to the first dose of study drug for women of child bearing potential (WOCBP).
- Administration of another investigational agent within 28 days or 5 half-lives for targeted therapy or immunotherapy (whichever is shorter) prior to study entry
- Use of prohibited medications
- Subjects with history of coagulopathy (or taking anticoagulants) including deep vein thrombosis (DVT)/pulmonary embolism (PE), myocardial infarction or stroke within the last 6 months.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00955812
Start Date
June 1 2009
End Date
November 1 2012
Last Update
February 12 2013
Active Locations (2)
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1
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, United States, 37203
2
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030