Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123877
Status:
TERMINATED
Last Update Posted:
2007-01-09
First Post:
2005-07-23
Brief Title:
Study of GPX-100 in the Treatment of Metastatic Breast Cancer
Sponsor:
Gem Pharmaceuticals
Organization:
Gem Pharmaceuticals
Study Overview
Official Title:
Phase II Open Label Non-Randomized Efficacy and Safety Study of an Intravenous Formulation of the Anthracycline Analog GPX-100 in the Treatment of Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this early Phase II multicenter trial is to determine the objective clinical response to GPX-100 an anthracycline similar to doxorubicin in up to 40 patients with newly diagnosed metastatic breast cancer GPX-100 is unique among anthracyclines because it is not converted to doxorubicinol during metabolism in the body This metabolite has been shown to be a major cause of damage to the heart cardiotoxicity in laboratory studies Eligible patients who are enrolled in this study will receive GPX-100 as a single agent at the beginning of as many as 8 three week long cycles of chemotherapy Objective measurements of tumor response will be made by computed tomography CT scans
Detailed Description:
Study Design - Two-stage multicenter open-label non-randomized study with intravenous IV dose administration of GPX-100 and limited dose-escalation and de-escalation After confirmation of the maximum tolerated dose MTD and interim analysis of efficacy and safety Stage I if necessary the study cohort will be enlarged to confirm the estimate of clinical efficacy Stage II using the established MTD
Sample Size - 20 patients in Stage I and up to 20 patients in Stage II
Dosage Form - IV solution of sterilized lyophilized powder in Sodium Chloride NaCl for Injection USP 09
Doses - 140 mgm2 GPX-100 with escalation to 170 mgm2 and de-escalation to 105 mgm2 depending upon clinical response and toxicity
Administration - One IV infusion every 3 weeks for up to 8 doses
Efficacy Parameters - Activity of GPX-100 will be evaluated in terms of measurable tumor response and disease progression according to RECIST criteria Blood samples will be obtained for determination of pharmacokinetic parameters and the presence of doxorubicinol following the first dose of GPX-100
Safety Parameters - Dose tolerance and treatment toxicity especially cardiotoxicity of GPX-100 will be evaluated A baseline medical history including Karnofsky Performance Status and a physical examination hematology profile CBC differential platelet count chemistry profile including electrolytes serum calcium liver and renal function tests urinalysis chest and abdominal CT scans and a bone scan will be done Interval history with adverse event AE assessment and performance status physical examination and hematology and clinical chemistry profile will be repeated every 3 weeks during treatment In addition hematology and chemistry profiles will be repeated weekly between treatment visits Chest and abdominal CTs and bone scans will be repeated at 6-week intervals as appropriate for tumor assessment An MRI of the brain will be performed at the baseline visit if clinically indicated Urinalysis will be repeated at six-week intervals during treatment Cardiotoxicity will be assessed with ECG and MUGA scans at baseline every 6 weeks during treatment and 6-8 weeks after the last dose of GPX-100 There will be continued follow-up at 6-8 week intervals if indicated by changing cardiac function until normal or stable Treatment will be discontinued if there is objective disease progression or unacceptable treatment toxicity A follow-up visit will occur 6-8 weeks after the last treatment visit for each patient whether the study was completed per protocol or the patient discontinues study treatment early for any reason The following evaluations will be performed at the follow-up visit physical examination adverse event assessment ECG MUGA scan hematology and clinical chemistry profiles and urinalysis Serum pregnancy tests will be performed at baseline and at the follow-up visit if necessary
Sample Size - 20 patients in Stage I and up to 20 patients in Stage II
Dosage Form - IV solution of sterilized lyophilized powder in Sodium Chloride NaCl for Injection USP 09
Doses - 140 mgm2 GPX-100 with escalation to 170 mgm2 and de-escalation to 105 mgm2 depending upon clinical response and toxicity
Administration - One IV infusion every 3 weeks for up to 8 doses
Efficacy Parameters - Activity of GPX-100 will be evaluated in terms of measurable tumor response and disease progression according to RECIST criteria Blood samples will be obtained for determination of pharmacokinetic parameters and the presence of doxorubicinol following the first dose of GPX-100
Safety Parameters - Dose tolerance and treatment toxicity especially cardiotoxicity of GPX-100 will be evaluated A baseline medical history including Karnofsky Performance Status and a physical examination hematology profile CBC differential platelet count chemistry profile including electrolytes serum calcium liver and renal function tests urinalysis chest and abdominal CT scans and a bone scan will be done Interval history with adverse event AE assessment and performance status physical examination and hematology and clinical chemistry profile will be repeated every 3 weeks during treatment In addition hematology and chemistry profiles will be repeated weekly between treatment visits Chest and abdominal CTs and bone scans will be repeated at 6-week intervals as appropriate for tumor assessment An MRI of the brain will be performed at the baseline visit if clinically indicated Urinalysis will be repeated at six-week intervals during treatment Cardiotoxicity will be assessed with ECG and MUGA scans at baseline every 6 weeks during treatment and 6-8 weeks after the last dose of GPX-100 There will be continued follow-up at 6-8 week intervals if indicated by changing cardiac function until normal or stable Treatment will be discontinued if there is objective disease progression or unacceptable treatment toxicity A follow-up visit will occur 6-8 weeks after the last treatment visit for each patient whether the study was completed per protocol or the patient discontinues study treatment early for any reason The following evaluations will be performed at the follow-up visit physical examination adverse event assessment ECG MUGA scan hematology and clinical chemistry profiles and urinalysis Serum pregnancy tests will be performed at baseline and at the follow-up visit if necessary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None