STAT3 Inhibitor for Solid Tumors

NCT00955812 | Completed Phase 1

• 1 other identifier: 2009-0206
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Cancer; Solid Tumor

Keywords

OPB-31121; Advanced Solid Tumor; STAT3; IL-6-induced STAT3 phosphorylation

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of OPB-31121

  The MTD is defined as the highest dose level at which \< 2 of 6 subjects experience dose limiting toxicity (DLT) during the first cycle.

  4 Week Cycle

Study Arms (1)

OPB-31121

EXPERIMENTAL

OPB-31121 50 mg by mouth 2 times a day on Days 1-21 of each 28-day cycle.

Drug: OPB-31121

Interventions

OPB-31121 DRUG

50 mg by mouth 2 times a day on Days 1-21 of each 28-day cycle.

OPB-31121

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Otsuka Pharmaceutical Development & Commercialization, Inc.: collaborator

Study Sites (2)

Sarah Cannon Research Institute (SCRI)

Nashville, Tennessee, 37203, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Bendell JC, Hong DS, Burris HA 3rd, Naing A, Jones SF, Falchook G, Bricmont P, Elekes A, Rock EP, Kurzrock R. Phase 1, open-label, dose-escalation, and pharmacokinetic study of STAT3 inhibitor OPB-31121 in subjects with advanced solid tumors. Cancer Chemother Pharmacol. 2014 Jul;74(1):125-30. doi: 10.1007/s00280-014-2480-2. Epub 2014 May 13.

  PMID: 24819685 DERIVED

Related Links

• UT MD Anderson Cancer Center website

Study Officials

• David S. Hong, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 10, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: February 12, 2013

Record last verified: 2013-02

Locations

US (2)