Phase 1 Study and Dose Seeking Study of an Intravenous Formulation of the Anthracycline Analog GPX-150 in Patients With Solid Tumors

Gem Pharmaceuticals1 site in 1 country27 target enrollmentJanuary 2008

ConditionsAdvanced Solid Tumors - Phase 1 Population

InterventionsGPX-150 for Injection

DrugsGPX-150 for Injection

Overview

Phase: Phase 1
Intervention: GPX-150 for Injection
Conditions: Advanced Solid Tumors - Phase 1 Population
Sponsor: Gem Pharmaceuticals
Enrollment: 27
Locations: 1
Primary Endpoint: Define maximum tolerated dose and identify dose limiting toxicities following IV administration of GPX-150 for Injection once every 3 weeks
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 1 safety and dose escalation study to define the maximum tolerated dose (MTD) and identify the dose limiting toxicities (DLT) following IV administration of GPX-150 once every 3 weeks. Escalating doses starting at the dose of 14 mg/m2 and increasing to the dose of 265 mg/m2 will be administered IV once every 3 weeks for up to 8 cycles of treatment. Patients who have previously received an anthracycline are limited to 4 cycles of treatment.

Registry

clinicaltrials.gov

Start Date

January 2008

End Date

October 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gem Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is at least 18 years of age.
•Patient has a histologically or cytologically confirmed diagnosis of solid tumor.
•Patient has progressive disease
•Patient is considered to have incurable disease and is not a candidate for known effective systemic treatment.
•Patient has a performance status of at least 70% on Karnofsky scale.
•Patient has not received any cytotoxic chemotherapy or other investigational agents within 4 weeks of the first treatment in this study (6 weeks for mitomycin or nitrosourea). Patients should receive supportive care as indicated. Patients currently receiving blood transfusions or erythropoiesis-stimulating agents should continue receiving them as per the ASCO guidelines. Patients requiring palliative radiation therapy should complete their course of radiation treatment 4 weeks before the first study treatment.
•Patient may have received unlimited prior hormonal therapy, but this must have been completed at least 4 weeks prior to the first study treatment, and progressive disease documented following withdrawal of hormone therapy. Patient with hormone-refractory prostate cancer on long acting LHRH agents may continue on these agents.
•Patient may have received unlimited prior biological or immunological therapy without limitation, but this must have been completed at least 4 weeks prior to the first study treatment.
•Patient has fully recovered from any previous surgery (at least 4 weeks since major surgery) and radiation therapy (at least 4 weeks since the end of treatment).
•Patient has recovered from reversible toxicity of prior therapy. Permanent and stable side effects or changes are acceptable if ≤ to Grade

Exclusion Criteria

•Patient is pregnant or breast-feeding.
•Patient has a history of hypersensitivity to anthracyclines.
•Patient has received a cumulative dose of doxorubicin that exceeds 300 mg/m2 or a cumulative dose of epirubicin that exceeds 540 mg/m
•Patient has received an anthracycline within 6 months prior to entry into the study.
•Patient has brain metastases unless asymptomatic and stable off glucocorticoids.
•Prior history of CHF, myocardial infarction within 6 months prior to enrollment, active ischemic heart disease, or uncontrolled hypertension.
•Patient requires active medical therapy for CHF or arrhythmia.
•Patients with \> Grade l motor neuropathy or \> Grade 2 sensory neuropathy.
•Patient has participated in a study of any investigational drug within 4 weeks prior to the first study treatment.
•Patient has received chemotherapy, hormonal therapy (with the exception of LHRH for prostate cancer), immunotherapy, biological therapy, or radiotherapy within 4 weeks prior to the first study treatment.