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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

September 7, 2007
January 3, 2012
August 2007
March 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Clinical laboratory tests [ Time Frame: Weekly ]
  • Vital signs [ Time Frame: Daily during dosing, then weekly during followup ]
  • Electrocardiograms (ECGs) [ Time Frame: Multiple times during dosing, then weekly during followup ]
  • Echocardiograms (ECHO) [ Time Frame: Baseline and every other cycle ]
Complete list of historical versions of study NCT00528047 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Tumor assessment [ Time Frame: Baseline and every other cycle ]
  • Blood sampling for pharmacokinetics [ Time Frame: Days 1 and 5 of dosing ]
Not Provided
Not Provided
 
Safety Study of PRLX 93936 in Patients With Advanced Solid Tumors
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

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cancer
Drug: PRLX 93936
PRLX 93936 will be administered intravenously over one hour daily for 5 days.
Experimental: PRLX 93936
Intervention: Drug: PRLX 93936
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
November 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00528047
PRLX93936-0001
No
Prolexys Pharmaceuticals
Prolexys Pharmaceuticals
Not Provided
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
Prolexys Pharmaceuticals
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP