Safety Study of GPX-150 in Patients With Solid Tumors

NCT ID: NCT00710125

Last Updated: 2014-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2013-10-31

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.

Conditions

Advanced Solid Tumors - Phase 1 Population

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GPX-150 for Injection

GPX-150 is administered IV on Day 1, followed by a 20 day rest period, every 3 weeks.

Group Type: EXPERIMENTAL

GPX-150 for Injection

Intervention Type: DRUG

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.

Interventions

GPX-150 for Injection

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.

Intervention Type: DRUG

Other Intervention Names

GPX-150; 5-imino-13-deoxy-doxorubicin HCl

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 2.
• Patient has adequate hematological function as defined by an ANC ≥ 1500, platelets ≥ 100,000/µL, and hemoglobin ≥9.0 gm/dL.
• Patient has adequate organ function defined as a bilirubin ≤ 1.5 times ULN, AST and ALT < 2.5 times the upper limit of normal (ULN, 5.0 times the ULN with liver involvement), serum creatinine <2.0 dL or estimated creatinine clearance ≥ 50 ml/min.
• Patient has an ejection fraction of 110% of the lower limit of institutional normal as determined by resting MUGA scan.
• Patient has an O2 Sat by pulse oximetry of at least 90%.
• Patient has a negative pregnancy test prior to study entry if premenopausal or if less than 12 months after menopause. Premenopausal patients must use a medically effective form of contraception during the treatment period.
• Patient is willing and able to comply with all study protocol requirements. The patient or a legally authorized representative must fully understand all elements of the informed consent and have signed the informed consent according to institutional and federal regulatory requirements.

• Patient has a serious, concurrent medical condition that would limit the patient's ability to complete or comply with the study requirements.
• Patient is unable or unwilling to comply with the contraceptive requirements during the study period.
• Patient has lymphoma.

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/m2.
• 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.
• Patient has had major surgery within 4 weeks of the first study treatment.
• Patient has received G-CSF or GM-CSF within 4 weeks prior to first dose of study drug.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gem Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond J Hohl, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

GPX-150-001

Identifier Type: -

Identifier Source: org_study_id