Know Cancer

or
forgot password

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


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

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


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.


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
- AST (SGOT), ALT (SGPT) and Alkaline phosphatase metastases are present, then
- 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 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical laboratory tests

Outcome Time Frame:

Weekly

Safety Issue:

Yes

Principal Investigator

Daniel Von Hoff, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

TGen Clinical Research Services at Scottsdale Healthcare

Authority:

United States: Food and Drug Administration

Study ID:

PRLX93936-0001

NCT ID:

NCT00528047

Start Date:

August 2007

Completion Date:

November 2011

Related Keywords:

  • Cancer
  • Cancer
  • Solid Tumor
  • Metastatic
  • Neoplasm, Malignant

Name

Location

Tower Cancer Research FoundationBeverly Hills, California  90211
Dana Farber Cancer InstituteBoston, Massachusetts  02115
TGen Clinical Research Services at Scottsdale HealthcareScottsdale, Arizona  85258