Preliminary Study of Mycograb and Docetaxel in Advanced Breast Cancer

NCT00217815 | Completed Phase 1

• 1 other identifier: NTP/ONC/001
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

Brief Summary

The study hypothesis is that the addition of Mycograb to docetaxel will improve outcome in advanced carcinoma of the breast.

Conditions

Cancer of the Breast

Outcome Measures

Primary Outcomes (1)

• Impact on tumour size when compared to historical controls

Secondary Outcomes (2)

• Safety data

• Pharmacokinetics data

Interventions

Mycograb, Docetaxel DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be female between the ages of 18 to 70 years old.
• Patients must have histologically or clinically confirmed metastatic and/or recurrent breast cancer amenable to treatment with docetaxel.
• Patients must have presence of at least one uni-dimensional measurable lesion with minimal lesion size \> 20 mm at the largest diameter.
• Patients may have had one previous chemotherapy regimen and must not have received prior chemotherapy with docetaxel.
• Patients must have been off all hormonal therapy for at least 2 weeks prior to initiation of therapy.
• Patients must have been off all chemotherapy or radiotherapy regimens for at least 4 weeks prior to initiation of chemotherapy.
• Patients must have a life expectancy of at least 6 months.
• Patients must have a ECOG status of 0, 1 or 2.
• Patients must be willing to complete all procedures and visits as outlined in the protocol.
• Patients must sign an informed consent form.
• Patients must have negative blood test for HIV and hepatitis B and C.
• Female patients of child bearing potential should use an effective method of contraception.

You may not qualify if:

• Patients with brain or meningeal metastases.
• Patients whose only measurable lesion is in the bone.
• Patients with clinically significant cardiovascular, pulmonary, renal, endocrine, hepatic, respiratory, neurologic, psychiatric, immunologic, gastrointestinal, hematologic, metabolic or any other condition or laboratory abnormality that in the opinion of the investigator makes the patient unsuitable for participation in the study.
• Patients with history of seizure disorder.
• Patients who have received treatment with any other investigational drug within the preceding one month.
• Patients who are pregnant or breast feeding.

Sponsors & Collaborators

• NeuTec Pharma: lead

Study Sites (3)

Chemotherapie Clinic of Medical University Lodz

Lodz, Pabianicka, 93-513, Poland

Location

Clinical Hospital Centre Bezanijska Kosa

Bezanijska Kosa Bb, Belgrade, 11000, Serbia

Location

Institute For Oncology and Radiology of Serbia

Pasterova 14, Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

efungumab; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Anna Pluzanska, MD

  University of Lodz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: September 1, 2005
• Study Completion: October 1, 2006
• Last Updated: July 15, 2008

Record last verified: 2008-07

Locations

PL (1); SE (2)