SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adult Cancer Patients Receiving Chemotherapy

Phase 2

Completed

• Conditions: Thrombocytopaenia
• Interventions: Other: Placebo; Drug: SB497115

• Registration Number: NCT00102726
• Lead Sponsor: GlaxoSmithKline

Brief Summary

SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 versus placebo as treatment for patients with advanced solid tumors scheduled to receive chemotherapy with carboplatin and paclitaxel every 21 days. Patients will receive SB497115 on days 2-11 of each 21 day cycle for at least 2 cycles of chemotherapy and for a maximum of 8 cycles of chemotherapy.

Detailed Description

A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel Group, Dose Ranging Study to Assess the Efficacy, Safety, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist (SB-497115-GR) Administered at 50, 75, and 100 mg to Cancer Patients Receiving Multiple Cycles of Chemotherapy

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-02-01
• Study First Submitted QC: 2005-02-01
• Study First Posted: 2005-02-02
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	Placebo	Placebo administered orally daily on days 2 through 11 of each 21-day cycle.
Arm 3	SB497115	SB-497115 100mg administered orally daily on days 2 through 11 of each 21-day cycle.
Arm 1	SB497115	SB-497115-GR 50mg. administered orally daily on days 2 through 11 for each 21-day cycle.
Arm 2	SB497115	SB-497115-GR 75 mg administered orally dailey on days 2-11 of each 21-day cycle.

Primary Outcome Measures

Name	Time	Method
Change in baseline platelet count from the first day of the second cycle of chemotherapy to the lowest count observed (nadir) during the cycle(21 days)	throughout entire study

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability, pharmacodynamics, changes in platelet count during cycle 1(21 days) and beyond cycle 2(21 days), population PK, and deliver intended doses of chemotherapy without thrombocytopenia related AEs	Throughout entire study
Change in platelet count from day 1 (baseline) to nadir during the first cycle and beyond the second cycle of carboplatin/paclitaxel	throughout study
Pharmacodynamic parameters including platelet count, grade of thrombocytopenia,serum thrombopoietin, and platelet aggregation/activation during the first and second cycles of carboplatin/paclitaxel	During first and second cycles of carboplatin/paclitaxel
Population PK of SB-497115, including clearance (CL/F), absorption rate constant(ka), and volume of distribution (V/F) with assessment of demographic covariates influencing SB-497115 PK	throughout study
The relationship between PK of SB-497115 andrelevant safety and efficacy endpoints will be explored	throughout study
Carboplatin/paclitaxel-associated thrombocytopenia-related AEs, as defined by NCI
Safety and tolerability as indicated by physical exam, 12-lead ECGs, ophthalmologic examinations, clinical laboratory tests, clinical monitoring/observation, and AE reporting	throughout study
Dose intensity (percent of intended dose) of carboplatin/paclitaxel
Common Terminology Criteria for Adverse Events, CTCAE v3.0, to include the number of platelet transfusions, bleeding events (hematoma), hemorrhage/bleeding,petechiae/purpura), clinical laboratory tests, and clinical observations	throughout study

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Leicester, United Kingdom