Safety Study of GPX-150 in Patients With Solid Tumors

NCT00710125 | Completed Phase 1

• 1 other identifier: GPX-150-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Define maximum tolerated dose and identify dose limiting toxicities following IV administration of GPX-150 for Injection once every 3 weeks

  Every 3 weeks

Secondary Outcomes (1)

• Pharmacokinetics and any antitumor activity

  Every 3 weeks

Study Arms (1)

GPX-150 for Injection

EXPERIMENTAL

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

Drug: GPX-150 for Injection

Interventions

GPX-150 for Injection 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.

Also known as: GPX-150, 5-imino-13-deoxy-doxorubicin HCl

GPX-150 for Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Gem Pharmaceuticals: lead

Study Sites (1)

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

5-imino-13-deoxydoxorubicin; Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Raymond J Hohl, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 4, 2008
• Study Start: January 1, 2008
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

US (1)