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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

Page last updated: November 03, 2008

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