Study to Assess the Pharmacokinetics and Pharmacodynamics of GSK461364 in Subjects With Non-Hodgkins Lymphoma

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Lymphoma, Non-Hodgkin

Treatments: Drug: GSK461364

Study type: Interventional

Funder types: Industry

Identifiers

NCT00536835

PLK107427

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

41 participants in 2 patient groups

Stage A

Experimental group

Description:

Stage A will identify maximum tolerated doses for either Schedule 1 - GSK461364 given once weekly on Day 1, 8 and 15 every 28 days; Schedule 2 - GSK 461364 given twice weekly Days 1, 2, 8, 9, 15 and 16; Schedule 3 Daily on Day 1 to Day 15 every 21 days.

Treatment:

Drug: GSK461364

Stage B

Experimental group

Description:

Evaluate safety, PK, pharmacodynamic (PD) \& tumor response in expanded cohorts at the MTD for at least one schedule from Stage A.

Treatment:

Drug: GSK461364