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Phase 1 Study and Dose Seeking Study of an Intravenous Formulation of the Anthracycline Analog GPX-150 in Patients With Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

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Trial Information

Phase 1 Study and Dose Seeking Study of an Intravenous Formulation of the Anthracycline Analog GPX-150 in Patients With Solid Tumors


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Every 3 weeks

Safety Issue:

Yes

Principal Investigator

Raymond J Hohl, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa

Authority:

United States: Food and Drug Administration

Study ID:

GPX-150-001

NCT ID:

NCT00710125

Start Date:

January 2008

Completion Date:

March 2012

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms

Name

Location

University of Iowa Hospital and ClinicsIowa City, Iowa  52242