Clinical Trials Logo
  1. Home
  2. Advanced Cancer
  3. NCT00664170
  4. Details
NCT00664170 Clinical Trial

A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer

Advanced Cancer Clinical Trial

Official title:
A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00664170
Other study ID # ANX 514-01
Secondary ID
Status Completed
Phase Phase 1
First received April 18, 2008
Last updated May 27, 2009
Start date April 2008
Est. completion date April 2009

Study information
Verified date May 2009
Source Mast Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ANX-514
75 mg/m^2
• docetaxel
75 mg/m^2

Locations
Country Name City State
Argentina Hospital Universitario Austral Buenos Aires Provincia de Buenos Aires
Argentina Marcelo T de Alvear Buenos Aires
Argentina Hospital Regional de Concepcion Concepcion Tucuman
Argentina Centro Oncologico de Integracion Regional Mendoza
Argentina Centro Oncologico de Rosario Rosario Santa Fe
Argentina Hospital Privado Santa Clara de Asis Salta
Argentina Isis Centro Especializado Santa Fe
Argentina Centro Medico San Roque Tucuman
Estonia Tallinn Cancer Clinic Tallinn
Estonia Tartu University Hospital, Clinic of Hematology and Oncology Tartu
United States UCSD Moores Cancer Center La Jolla California
United States Signal Point Hematology/Oncology Inc. Middletown Ohio
United States Northwest Alabama Cancer Center Muscle Shoals Alabama

Sponsors (1)
Lead Sponsor Collaborator
Mast Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Estonia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic equivalence of ANX-514 and Taxotere
See also
  Status Clinical Trial Phase
Completed NCT03181854 - Randomized Controlled Trial of Integrated Early Palliative Care N/A
Completed NCT01197170 - Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance Phase 1
Recruiting NCT05045040 - Empathetic Communication Facilitation Program for Early Initiation of End-of-life Discussions N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03994601 - An Investigational Immunotherapy Study of BMS-986288 Alone and in Combination With Nivolumab in Advanced Solid Cancers Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Completed NCT01393990 - A Study of LY2228820 in Participants With Advanced Cancer Phase 1
Completed NCT02857270 - A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic Cancer Phase 1
Recruiting NCT03175224 - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors Phase 2
Active, not recruiting NCT04121676 - Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer Phase 1
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Completed NCT03980041 - Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275) Phase 2
Active, not recruiting NCT03674567 - Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab Phase 1/Phase 2
Recruiting NCT04823377 - Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer. N/A
Completed NCT02778126 - A Study of Prexasertib (LY2606368) in Participants With Advanced Cancer Phase 1
Completed NCT02507544 - A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer Phase 1
Completed NCT02529553 - A Study of LY3076226 in Participants With Advanced or Metastatic Cancer Phase 1
Completed NCT02245204 - Phase I Studies of Chlorogenic Acid for Injection for Tolerance and Pharmacokinetic of Advanced Cancers Phase 1
Completed NCT01901237 - Yoga for Adolescent and Young Adult Non-Curative Cancer Patients N/A
Completed NCT01583777 - Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer Phase 1