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Study Summary
No. 2008-0104:.......Solid Tumors......Aung Naing......Investigational Cancer Therapeutics
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Study Summary Title
Study Summary
Number:
2008-0104
Study Title:An Open-label, Randomized, Two-way Balanced Crossover Study to Investigate the Bioavailability of two forms of GSK1363089 in Subjects with Solid Tumors
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Physician New Patient Referral
Name:Aung NaingPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Investigational Cancer TherapeuticsReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-1930
Contact us about clinical trials
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General Information
Disease Group:Solid TumorsSupported By:GlaxoSmithKline
Phase of Study:Phase IReturn
Visit:
Screening, 9 days during Part 1, every 2 weeks during Part 2 for the first 6
months, Follow-up visit
Treatment
Agents:
GSK1363089Home Care:N/A
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
N?A
Description/
Intervention:
The goal of this clinical research study is to learn more about GSK1363089.

This investigational drug has been made one way up until now, and the drug's
maker has designed a different way of making it. This study will compare the 2
forms of the drug when given to patients with advanced solid tumors.

Researchers want to learn if the second form of GSK1363089 is the same as the
first form of GSK1363089.
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Study Objectives / Outcomes
Primary
To evaluate the relative bioavailability of GSK1363089 from single dose administration as a free base formulation (GSK1363089G) compared to the bisphosphate salt formulation (GSK1363089A) in Part 1 of the study.

Secondary
  • To assess the safety of GSK1363089A administered three times a week in subjects with solid tumors in Part 2 of the study.
  • To assess the safety of GSK1363089 from single dose administration as free base and bisphosphate salt formulations in Part 1 of the study.
  • To determine GSK1363089 concentrations (nominal peak and trough) during Week 3 of GSK1363089A given three times a week in subjects with solid tumors in Part 2 of the study.
  • To assess efficacy of the drug with intermittent dosing among patients who choose to participate in Part 2 of the study.

Exploratory
To identify tumor-derived or blood-derived pharmacodynamic biomarkers related to GSK1363089, and to measure drug concentrations in tissue.
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Study Status Information
Study Activation / Registration Date:08/11/2008
IRB Review and Approval Date:08/11/2008
Study Type:Phase I
Recruitment Status:Terminated
Projected Accrual:20
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Written informed consent provided.

2) Histologically or cytologically confirmed diagnosis of solid tumor malignancy that is not responsive to standard therapies or for which there is no approved therapy.

3) 18 years old or older.

4) Performance Status score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale.

5) A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) >40 mIU/mL and estradiol <40 pg/mL (<140 pmol/L) is confirmatory].

6) (continued from above) Child-bearing potential and agrees to use one of the contraception methods listed in protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point.

7) Male subjects must agree to use one of the contraception methods listed in protocol. This criterion must be followed from the time of the first dose of study medication as determined by the investigator in conjunction with a GSK Study Physician.

8) Able to swallow and retain oral medication.

9) The subject is willing to refrain from the use of illicit drugs and adhere to other protocol-stated restrictions while participating in the study.

10) QTcB or QTcF < 450 msec for men and < 470 msec for women.

11) Bilirubin </= 1.5mg/dl, AST, ALT, ALP <2X ULN in absence of malignant disease in the liver or <5X ULN in case of liver involvement by the tumor.

12) Serum Creatinine <1.5mg/dL

Exclusion Criteria:1) The subject has received anticancer treatment (e.g., chemotherapy, radiotherapy, cytokines) within 14 days (6 weeks for nitrosoureas or mitomycin C) before the first dose of study drug, or has not recovered to Grade </= 1 from AEs due to agents administered more than 30 days earlier.

2) The subject has participated in a clinical trial and has received an investigational product within 21 days prior to the first dosing day in the current study.

3) The subject has known brain metastases.

4) The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

5) History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Study Physician, contraindicates their participation.

6) The subject is known to be positive for the human immunodeficiency virus (HIV).

7) Subjects who have had partial or complete gastrectomy.

8) Pregnant females as determined by positive B-hCG test at screening or prior to dosing.

9) Lactating females.

10) Unwillingness or inability to follow the procedures outlined in the protocol.

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Links
Registration Number: NCT00742261
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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