Safety Study of GPX-150 in Patients With Solid Tumors
This study has suspended participant recruitment.
(Transfer of Sponsorship)
Information provided by:
First received: July 2, 2008
Last updated: June 8, 2011
Last verified: June 2011
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.
Advanced Solid Tumors
Drug: GPX-150 for Injection
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase 1 Study and Dose Seeking Study of an Intravenous Formulation of the Anthracycline Analog GPX-150 in Patients With Solid Tumors
Primary Outcome Measures:
- Define maximum tolerated dose and identify dose limiting toxicities following IV administration of GPX-150 for Injection once every 3 weeks [ Time Frame: Every 3 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetics and any antitumor activity [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
Experimental: GPX-150 for Injection
GPX-150 is administered IV on Day 1, followed by a 20 day rest period, every 3 weeks.
Drug: 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.
- 5-imino-13-deoxy-doxorubicin HCl
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710125
|University of Iowa Hospital and Clinics
|Iowa City, Iowa, United States, 52242 |
||Raymond J Hohl, MD, PhD
||University of Iowa
No publications provided
||SVP, Regulatory Affairs, Coronado Biosciences, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 2, 2008
||June 8, 2011
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 20, 2014