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An Open-label, Multi-center Study to Evaluate the Effects of ASA404 Alone and in Combination With Taxane-based Chemotherapy on the Pharmacokinetics of Simvastatin, Caffeine, Omeprazole, and Diclofenac in Patients With Advanced Solid Tumor Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumor Malignancies

Thank you

Trial Information

An Open-label, Multi-center Study to Evaluate the Effects of ASA404 Alone and in Combination With Taxane-based Chemotherapy on the Pharmacokinetics of Simvastatin, Caffeine, Omeprazole, and Diclofenac in Patients With Advanced Solid Tumor Malignancies


Inclusion Criteria:



Histologically-proven and radiologically-confirmed diagnosis of advanced or metastatic
solid tumors for whom treatment with an investigational agent alone or in combination with
docetaxel or placlitaxel +carboplatin is appropriate;

- Body Mass Index (BMI) must be within the range of 18-30;

- A minimum of 4 weeks must have elapsed since the last treatment with other cancer
therapies, (i.e. endocrine therapy, immunotherapy, chemotherapy, ect);

- Willing and able to remain in the clinic for at least 2 days (the night before dosing
and the night after dosing 24 hours) for the 3 x's receiving the cocktail (on Day 1,
Day 8 and Day 15 during the

Exclusion Criteria:

- Patients having CNS metastases. (Patients having any clinical signs of CNS metastases
must have a CT or MRI of the brain performed to rule out CNS metastases in order to
be eligible for the study participation. Patients who have had brain metastases
surgically removed or irradiated with no active residual disease confirmed by imaging
are allowed)

- Patients who have not recovered from all acute radiotherapy-related toxicities;

- Prior exposure to Vascular Disrupting Agents (VDAs) or other vascular targeting
agents

- Right bundle branch block (RBBB), complete left bundle branch block (LBBB),
bifascicular block (right bundle branch block with either left anterior hemiblock or
left posterior hemiblock)

- Concomitant use of drugs with a risk of QT prolongation and/or causing torsade de
pointes

If patient will be treated with paclitaxel:

- Known allergy or hypersensitivity to platinum-containing drugs, taxanes, other drugs
formulated in Cremophor EL (polyoxyethylated castor oil) or any known excipients of
these drugs

- Oral, implantable, or injectable contraceptives may be affected by cytochrome P450
interactions while taking paclitaxel and therefore are not considered effective
contraceptive methods for this study when used as a single agent. Patients taking
oral, implantable, or injectable contraceptives who are not willing or otherwise
unable to use a concomitant barrier method will be excluded. The Investigator shall
counsel the patient accordingly. For a list of substrates of human liver microsomal
P450 enzymes, visit website (http://medicine.iupui.edu/flockhart/)

Other protocol-defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

evaluate the effects of ASA404 on the pharmacokinetics of a cocktail of simvastatin, caffeine, omeprazole, and diclofenac in patients with advanced malignancies.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CASA404A2111

NCT ID:

NCT01290380

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Solid Tumor Malignancies
  • Solid tumor malignancies,
  • simvastatin,
  • caffeine,
  • omeprazole and diclofenac,
  • ASA404,
  • PK data
  • Neoplasms

Name

Location

The University of Texas Science Center at HoustonHouston, Texas  77030
University of Wisconsin & Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792