Safety Study of PRLX 93936 in Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prolexys Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00528047
First received: September 7, 2007
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Cancer
Drug: PRLX 93936
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Prolexys Pharmaceuticals:

Primary Outcome Measures:
  • Clinical laboratory tests [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: Daily during dosing, then weekly during followup ] [ Designated as safety issue: Yes ]
  • Electrocardiograms (ECGs) [ Time Frame: Multiple times during dosing, then weekly during followup ] [ Designated as safety issue: Yes ]
  • Echocardiograms (ECHO) [ Time Frame: Baseline and every other cycle ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumor assessment [ Time Frame: Baseline and every other cycle ] [ Designated as safety issue: No ]
  • Blood sampling for pharmacokinetics [ Time Frame: Days 1 and 5 of dosing ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: August 2007
Study Completion Date: November 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PRLX 93936 Drug: PRLX 93936
PRLX 93936 will be administered intravenously over one hour daily for 5 days.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00528047

Locations
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
Investigators
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
  More Information

No publications provided

Responsible Party: Prolexys Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00528047     History of Changes
Other Study ID Numbers: PRLX93936-0001
Study First Received: September 7, 2007
Last Updated: January 3, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Prolexys Pharmaceuticals:
Cancer
Solid Tumor
Metastatic
Neoplasm, Malignant

ClinicalTrials.gov processed this record on July 23, 2014