safety study of gpx-150 in patients with solid tumors

Conditions: Advanced Solid Tumors - Phase 1 Population

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.


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. 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. * patient has baseline laboratory values that are outside normal ranges or those listed (see inclusion criteria), which are clinically significant as determined by the investigator. * 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.