Lymphoma, Non-Hodgkin
Conditions
Keywords
Non-Hodgkins Lymphoma, Cancer, First time in human, PLK1 inhibitor, Advanced Solid Tumor, GSK461364
Brief summary
This is a first time in human study that is being done to determine the maximum tolerated dose and initial pharmacokinetic parameters of GSK461364, given by IV, in adult subjects with solid tumors and Non-Hodgkins lymphoma.
Interventions
DRUGGSK461364
GSK461364 will be given intravenously as a 4 hour infusion in either a final volume of 500 or 1000 mLs. The starting dose for Stage A - Schedule 1 was 50 mg and doses were to be escalated as described in protocol until maximum tolerated dose established.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of advanced solid tumor or Non-Hodgkins Lymphoma (excluding HIV-associated lymphoma) that has relapsed or is refractory to standard therapies * At least 18 years of age * Female who are of non-childbearing potential or who have a negative pregnancy test who uses approved contraception * Male with a female partner of childbearing potential must have had a vasectomy or both are using approved contraception * Lab values that are within range as described in the protocol * Paraffin-embedded archival tumor tissue available for testing * Signed written informed consent
Exclusion criteria
* Undergone major surgery or received anti-cancer therapy * History of hemolytic anemia * Clinical lab tests that are out of range as described in the protocol * Females who are pregnant or lactating * Significant heart problems * Serious or unstable pre-existing medical or psychiatric condition * Are not able to comply with the study protocol * Use of prohibited medications * Have low blood pressure * Evidence of symptomatic or untreated central nervous system involvement and require corticosteroids or anti-epileptic meds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma levels for GSK461364 will be taken at:Schedule 1:Day 1, 8, 15, & 22 for Cycle 1 and Day 1, 8 & 15 for subsequent cycles.Schedule 2:Day 1, 2, 8, 9, 15, & 16 for all cycles.Schedule 3:Day 1 to 5 for all cycles. | 16 Days |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be evaluated by: - Physical exam at screen & then D1 for each cycle - 12 lead ECG & telemetry at screen & Wk 1 to 3 for Schedule 1 & 2, & Wk 1 & 2 (ECG only) for Schedule 3. - Lab tests & AE monitoring throughout the study. | 16 Days |
Countries
United Kingdom
Outcome results
None listed