Safety Study of PRLX 93936 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00528047
Recruitment Status : Completed
First Posted : September 11, 2007
Last Update Posted : January 5, 2012
Information provided by (Responsible Party):
Prolexys Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Cancer Drug: PRLX 93936 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Multi-center, Open-Label, Dose-Escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of PRLX 93936 Administered Intravenously Daily for Five Days Followed by a 23-Day Rest Period in Patients With Advanced Solid Tumors
Study Start Date : August 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
Experimental: PRLX 93936 Drug: PRLX 93936
PRLX 93936 will be administered intravenously over one hour daily for 5 days.

Primary Outcome Measures :
  1. Clinical laboratory tests [ Time Frame: Weekly ]
  2. Vital signs [ Time Frame: Daily during dosing, then weekly during followup ]
  3. Electrocardiograms (ECGs) [ Time Frame: Multiple times during dosing, then weekly during followup ]
  4. Echocardiograms (ECHO) [ Time Frame: Baseline and every other cycle ]

Secondary Outcome Measures :
  1. Tumor assessment [ Time Frame: Baseline and every other cycle ]
  2. Blood sampling for pharmacokinetics [ Time Frame: Days 1 and 5 of dosing ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00528047

United States, Arizona
TGen Clinical Research Services at Scottsdale Healthcare
Scottsdale, Arizona, United States, 85258
United States, California
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90211
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Prolexys Pharmaceuticals
Principal Investigator: 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

Responsible Party: Prolexys Pharmaceuticals Identifier: NCT00528047     History of Changes
Other Study ID Numbers: PRLX93936-0001
First Posted: September 11, 2007    Key Record Dates
Last Update Posted: January 5, 2012
Last Verified: January 2012

Keywords provided by Prolexys Pharmaceuticals:
Solid Tumor
Neoplasm, Malignant