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STAT3 Inhibitor for Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00955812
First received: August 7, 2009
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Advanced Cancer
Solid Tumor
Drug: OPB-31121
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Dose Escalation, Non-randomized Study to Assess the Pharmacokinetics, Dose Limiting Toxicity, and Maximum Tolerated Dose of OPB-31121 in Subjects With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum Tolerated Dose (MTD) of OPB-31121 [ Time Frame: 4 Week Cycle ] [ Designated as safety issue: Yes ]
    The MTD is defined as the highest dose level at which < 2 of 6 subjects experience dose limiting toxicity (DLT) during the first cycle.


Enrollment: 24
Study Start Date: June 2009
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPB-31121
OPB-31121 50 mg by mouth 2 times a day on Days 1-21 of each 28-day cycle.
Drug: OPB-31121
50 mg by mouth 2 times a day on Days 1-21 of each 28-day cycle.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Male and female subjects >/= 18 years of age.
  3. 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.
  4. Eastern Cooperative Oncology Group (ECOG) performance status: </= 2
  5. Subjects must have a life expectancy of longer than 3 months.
  6. 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
  7. 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.
  8. 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.
  9. Subjects must have a normal ejection fraction (>/= 50%) as measured by either echocardiogram or multi gated acquisition (MUGA) scan.

Exclusion Criteria:

  1. 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.
  2. Known central nervous system (CNS) metastasis.
  3. 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.
  4. 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.
  5. 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).
  6. Administration of another investigational agent within 28 days or 5 half-lives for targeted therapy or immunotherapy (whichever is shorter) prior to study entry
  7. Use of prohibited medications
  8. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955812

Locations
United States, Tennessee
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, United States, 37203
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Principal Investigator: David S. Hong, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00955812     History of Changes
Other Study ID Numbers: 2009-0206
Study First Received: August 7, 2009
Last Updated: February 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
OPB-31121
Advanced Solid Tumor
STAT3
IL-6-induced STAT3 phosphorylation

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014