Safety and Maximum Tolerated Dose (MTD) Study of INNO-206 in Subjects With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1b open-label study evaluating the preliminary safety and maximum tolerated dose of a new formulation of INNO-206 administered at doses of 230 mg/m2, 350 mg/m2 and 450 mg/m2 (165, 260, 325 mg/m2 doxorubicin equivalents, respectively) through intravenous infusion on Day 1 every 21 days for up to 6 cycles.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CytRx
• Treatments: Doxorubicin; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Age between 18 and 70 years, male or female.

• Histologically or cytologically confirmed malignant solid tumor that has relapsed or is refractory to standard therapy.

• Subjects who have received prior radiation therapy with stable CNS metastasis with no progression of brain metastasis by CT/MRI scan in last 4 weeks.

• Capable of providing informed consent and complying with trial procedures.

• ECOG performance status 0-2.

• Life expectancy >12 weeks.

• Measurable or evaluable disease according to RECIST 1.1 criteria.

• Women must not be able to become pregnant (e.g. post menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study.

• Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.

• Geographic accessibility to the site.

Exclusion Criteria:

• Palliative surgery, chemotherapy, immunotherapy and/or radiation less than 4 weeks prior to the Screening Visit.

• Exposure to any investigational agent within 30 days of the Screening Visit.

• Laboratory values: Screening serum creatinine greater than or equal to 1.5 mg/dL, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count < 3500/mm3, absolute neutrophil count < 2000/mm3, platelet concentration < 100,000/mm3, hematocrit level < 33% for females or < 35% for males, or coagulation tests (PT,PTT) >1.5 times the upper limit or normal.

• Clinically evident congestive heart failure > class II of the New York Heart Association (NYHA) guidelines.

• Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.

• History or signs of active coronary artery disease with or without angina pectoris.

• Serious myocardial dysfunction defined scintigraphically (MUGA, myocardial scintigram)or ultrasound determined absolute left ventricular ejection fraction (LVEF) < 45% of predicted.

• History of HIV infection.

• Active, clinically significant serious infection requiring treatment with antibiotics, antivirals or antifungals.

• Major surgery within 3 weeks prior to treatment.

• Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.

• Any condition that is unstable and could jeopardize the subject's participation in the study.