Study of GPX-100 in the Treatment of Metastatic Breast Cancer
|First Received Date ICMJE||July 23, 2005|
|Last Updated Date||January 5, 2007|
|Start Date ICMJE||March 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE
||Efficacy: Sum of complete responders and partial responders. Safety: A decrease in cardiac ejection fraction by MUGA scans.|
|Change History||Complete list of historical versions of study NCT00123877 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Study of GPX-100 in the Treatment of Metastatic Breast Cancer|
|Official Title ICMJE||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|
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.
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 (0.9%).
Doses - 140 mg/m2 GPX-100 with escalation to 170 mg/m2 and de-escalation to 105 mg/m2 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 Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Drug: GPX-100 (13-deoxydoxorubicin)|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Completion Date||November 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States, Bulgaria|
|NCT Number ICMJE||NCT00123877|
|Other Study ID Numbers ICMJE||GPX-100-003|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Gem Pharmaceuticals|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Gem Pharmaceuticals|
|Verification Date||January 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP