Last updated: 11/04/2018 02:53:06
Dose-Escalation Study Of SB-485232 Administered As Daily Subcutaneous Injections In Adults With Solid Tumors
GSK study ID
485232/002
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase I, Dose Escalation Study to Assess the Safety and Pharmacokinetics of SB- 485232 Administered as Daily Subcutaneous Injections in Adult Patients with Solid Tumors
Trial description: This is a phase I, open-label, dose-escalation study of SB-485232. Subjects will receive SB-485232 administered as subcutaneous injections daily for 14 days. Dose escalation (enrollment into the next cohort) cannot occur until all three subjects have completed the previous cohort; 5 doses will be tested. An additional dosing regimen has been added to evaluate higher doses given twice weekly for 7 weeks. Therefore, the full evaluation period for each patient will extend out to approximately eleven weeks after the first day of SB-485232 dosing.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
- Safety and tolerability endpoints will include evaluation of adverse events and changes in laboratory values and clinical variables from pre-dose values.
Timeframe: 11 Weeks
Secondary outcomes:
- Biologically effective dose based. - Pharmacokinetic endpoints: AUC, Adverse Events, cmax, tmax, and t1/2. - Presence or absence of anti-SB-485232 antibodies. - Pharmacodynamic endpoints. - Radiographic tumor assessments.
Timeframe: 11 Weeks
Interventions:
Enrollment:
25
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Solid Tumor Cancer
Product
iboctadekin
Collaborators
Not applicable
Study date(s)
January 2003 to February 2006
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Histologically or cytologically confirmed diagnosis of malignancy.
- Subjects with solid tumors must have locally advanced or metastatic disease at the time of enrollment.
- Women who are pregnant or are breast-feeding.
- Severe or uncontrolled infections requiring systemic antibiotic therapy.
Inclusion and exclusion criteria
Inclusion criteria:
- Histologically or cytologically confirmed diagnosis of malignancy.
- Subjects with solid tumors must have locally advanced or metastatic disease at the time of enrollment.
- Measurable or evaluable disease that is refractory or resistant to standard therapy or for which there is no effective standard therapy.
- Predicted life expectancy of at least 12 weeks.
- Kinesin spindle protein (KPS) of greater than 70%.
- No chemotherapy, immunotherapy, hormonal therapy, or biological therapy for cancer, radiotherapy, or surgical procedures (except for minor surgical procedures) within 4 weeks before beginning treatment with SB-485232 (6 weeks for nitrosoureas and mitomycin C).
- Subjects must have recovered from toxicities (incurred as a result of previous therapy) sufficiently to be entered into a Phase I study.
- Provide written informed consent.
- Absence of anti-SB-485232 antibodies.
- Hemoglobin greater than or equal to 9 g/dL.
- Absolute neutrophil count greater than or equal to 1.5 X 109 /L.
- Platelet count greater than or equal to 100 X 109 /L.
- Partial thromboplastin time (PTT) and prothrombin time/international normalized ratio (PT/INR) within normal limits.
- Serum creatinine less than or equal to 1.5 mg/dL (135 µmol/L) or estimated creatinine clearance greater than 50 mL/min (calculated by the Cockcroft-Gault Formula).
- Total serum bilirubin less than or equal to 1.5 mg/dL.
- Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3 X ULN.
- Sexually active males or females of reproductive capacity must use adequate contraception.
- For subjects with a history of coronary artery disease, stress test must be within normal limits.
- Subjects with a history of congestive heart failure, myocardial infarction or prior anthracycline chemotherapy must have a Multiple Gated Acquisition (MUGA) scan with a left ventricular ejection fraction of greater than 40%.
Exclusion criteria:
- Women who are pregnant or are breast-feeding.
- Severe or uncontrolled infections requiring systemic antibiotic therapy.
- Any serious medical or psychiatric disorder that would interfere with subject safety or informed consent.
- Known leptomeningeal disease or evidence of prior or current metastatic brain disease.
- Receiving concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy.
- Receiving concurrent systemic steroids.
- History of ventricular arrhythmias requiring drug or device therapy.
- Any severe concurrent disease or condition, including significant autoimmune diseases, which in the judgment of the principal investigator, would make the subject inappropriate for study participation.
- Any unresolved or unstable serious toxicity from prior administration of another investigational drug.
- Any investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of SB-485232.
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the study.
- Received prior treatment with SB-485232.
- Poor venous access.
Trial location(s)
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, California, United States, 90404-2104
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27705
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19111
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-24-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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