A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer
Information source: Adventrx Pharmaceuticals
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Cancer
Intervention: ANX-514 (Drug); docetaxel (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Adventrx Pharmaceuticals Official(s) and/or principal investigator(s):
Jeff Stewart, MBA, Study Director, Affiliation: Adventrx Pharmaceuticals
Summary
The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere
in patients with advanced cancer.
Clinical Details
Official title: A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer
Study design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study
Primary outcome: Pharmacokinetic equivalence of ANX-514 and Taxotere
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Over 18 years old.
- Advanced cancer potentially sensitive to single agent docetaxel; ie.. locally advanced
or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone
refractory metastatic prostate cancer, other tumor type with no standard treatment.
- ECOG performance status of 0-2 and Karnofsky Score of 100-70.
Exclusion Criteria:
- Patients who have more effective therapy available than single agent docetaxel for the
malignancy.
- Pregnancy or lactation.
- Intolerance to any antineoplastic agents belonging to the taxoid family.
- Hypersensitivity to drugs formulated with polysorbate 80.
- Active infection.
- Prior anticancer therapy within 30 days prior to the first day of study treatment.
- Participation in another experimental drug study within 30 days prior to the first day
of study treatment.
Locations and Contacts
Centro Oncologico de Integracion Regional, Mendoza 5500, Argentina; Recruiting
Lino Arboit, M.D., Phone: 54 261 425 2575
Hospital Privado Santa Clara de Asis, Salta 4400, Argentina; Recruiting
Gerardo Arroyo, M.D., Phone: 54 9387 500 8788
Isis Centro Especializado, Santa Fe S3000FFU, Argentina; Recruiting
Cesar Blajman, M.D., Phone: 54 342 456 1669
Centro Medico San Roque, Tucuman 4000, Argentina; Recruiting
Juan Zarba, M.D., Phone: 54 381 422 1480
Marcelo T de Alvear, Buenos Aires 1122, Argentina; Recruiting
Carlos Bas, M.D., Phone: 54 11 4963 9500
Tartu University Hospital, Clinic of Hematology and Oncology, Tartu 51003, Estonia; Recruiting
Peeter Padrik, MD, PhD, Phone: 372 53 319 800
Tallinn Cancer Clinic, Tallinn 10167, Estonia; Recruiting
Andrus Magi, MD, Phone: 372 50 58 436
Northwest Alabama Cancer Center, Muscle Shoals, Alabama 35661, United States; Recruiting
Sharon Scogin, R.N., Phone: 256-381-1001
UCSD Moores Cancer Center, La Jolla, California 92093, United States; Recruiting
Sue Ann Castro, Phone: 858-822-5353
Signal Point Hematology/Oncology Inc., Middletown, Ohio 45042, United States; Recruiting
Susan Smith, Phone: 513-423-0504
Hospital Universitario Austral, Buenos Aires, Provincia de Buenos Aires, Argentina; Recruiting
Justina Martinez, M.D., Phone: 54 2322 48 2000
Centro Oncologico de Rosario, Rosario, Santa Fe CP 2000, Argentina; Recruiting
Luis Fein, M.D., Phone: 54 9341 572 0193
Hospital Regional de Concepcion, Concepcion, Tucuman 4146, Argentina; Recruiting
Hugo Requejo, M.D., Phone: 54 386 542 1784
Additional Information
Starting date: April 2008
Last updated: October 28, 2008
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