Safety Study of PRLX 93936 in Patients With Advanced Solid Tumors

NCT ID: NCT00528047

Last Updated: 2012-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2011-11-30

Brief Summary

The purpose of this study is to test the safety of PRLX 93936 and see what kind of effect it has on patients and their cancer. This study will also determine the highest dose of PRLX 93936 that can be given without causing adverse side effects and the dose of PRLX 93936 that should be used in future studies.

Detailed Description

This study will assess the safety, pharmacokinetics, and pharmacodynamics of PRLX 93936 administered intravenously over 1 hr daily for 5 days in patients with advanced solid tumors. Patients will be evaluated prior to dosing, during dosing and following dosing, on a 28-day cycle. Tumor response will be evaluated every other cycle.

Three patients will be assigned per dose level until the Maximum Tolerated Dose (MTD) is reached or a a Dose-Limited Toxicity (DLT) is encountered. Sequential cohorts of three patients will be treated with escalating doses until the Maximum Tolerated Dose (MTD) is reached.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRLX 93936

Group Type: EXPERIMENTAL

PRLX 93936

Intervention Type: DRUG

PRLX 93936 will be administered intravenously over one hour daily for 5 days.

Interventions

PRLX 93936

PRLX 93936 will be administered intravenously over one hour daily for 5 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed solid tumors
• Tumor progression after receiving standard/approved chemotherapy and for whom no available treatment provides clinical benefit
• One or more metastatic tumors measurable on a CT scan or MRI per RECIST criteria
• ECOG performance 0-1
• Life expectancy of at least 3 months
• Age >/= 18 years
• A negative pregnancy test (if female of child-bearing potential)
• Acceptable liver function:
• Bilirubin </= 1.5 times the Upper Limit of Normal (ULN)
• AST (SGOT), ALT (SGPT) and Alkaline phosphatase </= 2.5 times ULN (if liver metastases are present, then </= 5 times ULN is allowed)
• Acceptable renal function:
• Serum creatinine within normal limits, OR calculated creatinine clearance >/= 60 mL/min/1.73m2 for patients with creatinine levels above institutional normal
• Acceptable hematologic status:
• Granulocyte count >/= 1500 cells/mm3
• Platelet count >/= 100,000 (plt/mm3)
• Hemoglobin >/= 9.0 g/dL
• Urinalysis: no clinically significant abnormalities
• Acceptable coagulation status:
• PT within normal limits
• aPTT within normal limits
• Completed any chemotherapy, major surgery, or irradiation at least four weeks before enrollment in this study (six weeks for mitomycin-C or nitrosoureas, and two weeks for "targeted" therapies such as kinase inhibitors). Patient must have recovered from all toxicities incurred as a result of previous therapy.
• QT intervals of QTC </= 450 msec for men and </= 470 msec for women (as measured by Hodges equation)
• Left ventricular ejection fraction >/= 50% by 2D Echocardiogram (or > institutional lower limits of normal)

Exclusion Criteria

• NYHA Class III or IV, cardiac disease, myocardial infarction within the past six months, unstable arrhythmia, or evidence of ischemia on ECG
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
• Pregnant or nursing women
• Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within four weeks prior to study entry (six weeks for mitomycin-C or nitrosoureas and two weeks for targeted therapies such as kinase inhibitors).
• Unwillingness or inability to comply with protocol procedures
• Known current infection with HIV, hepatitis B or hepatitis C
• Currently receiving any other investigational agent
• Currently receiving medications metabolized by the cytochrome P450 3A4 enzyme pathway
• Presence of clinically apparent central nervous system metastases or carcinomatous meningitis. Patients with brain metastases which are well controlled (patients not taking dexamethasone or anti-seizure medication >/= three months after treatment) may be enrolled.
• Any other severe concurrent disease, which in the judgement of the investigator would make the patient inappropriate for the study
• Diagnosis of hypertension
• Previously enrolled in this trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prolexys Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Von Hoff, M.D.

Role: PRINCIPAL_INVESTIGATOR

TGen Clinical Research Services at Scottsdale Healthcare

Peter J. Rosen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tower Cancer Research Foundation

Andrew Wagner, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

TGen Clinical Research Services at Scottsdale Healthcare

Scottsdale, Arizona, United States

Tower Cancer Research Foundation

Beverly Hills, California, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

PRLX93936-0001

Identifier Type: -

Identifier Source: org_study_id