Safety Study of PRLX 93936 in Patients With Advanced Solid Tumors

NCT00528047 | Completed Phase 1

• 1 other identifier: PRLX93936-0001
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

Cancer; Solid Tumor; Metastatic; Neoplasm, Malignant

Outcome Measures

Primary Outcomes (4)

• Clinical laboratory tests

  Weekly

• Vital signs

  Daily during dosing, then weekly during followup

• Electrocardiograms (ECGs)

  Multiple times during dosing, then weekly during followup

• Echocardiograms (ECHO)

  Baseline and every other cycle

Secondary Outcomes (2)

• Tumor assessment

  Baseline and every other cycle

• Blood sampling for pharmacokinetics

  Days 1 and 5 of dosing

Study Arms (1)

PRLX 93936

EXPERIMENTAL

Drug: PRLX 93936

Interventions

PRLX 93936 DRUG

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

PRLX 93936

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Prolexys Pharmaceuticals: lead

Study Sites (3)

TGen Clinical Research Services at Scottsdale Healthcare

Scottsdale, Arizona, 85258, United States

Location

Tower Cancer Research Foundation

Beverly Hills, California, 90211, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel Von Hoff, M.D.

  TGen Clinical Research Services at Scottsdale Healthcare

  PRINCIPAL INVESTIGATOR

• Peter J. Rosen, M.D.

  Tower Cancer Research Foundation

  PRINCIPAL INVESTIGATOR

• Andrew Wagner, M.D., Ph.D.

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 11, 2007
• Study Start: August 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

US (3)