ABI-008 Trial in Patients With Metastatic Breast Cancer

NCT00531271 | Terminated Phase 1

• 1 other identifier: CA302
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-008 giver every 3 weeks; to characterize the toxicities of ABI-008; and to determine the pharmacokinetic parameters for ABI-008 when given on an every-3-week schedule to patients with metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-008 giver every three weeks.

  End of Study (EOS) and Follow Up

Secondary Outcomes (1)

• To evaluate the safety and tolerability of ABI-008 in the metastatic breast cancer patient population; and to determine the pharmacokinetic parameters for ABI-008 when given on an every-3-week schedule.

  End of Study (EOS) and Follow Up

Interventions

ABI-008 (nab-docetaxel) DRUG

ABI-008; 60-200 mg/m²; Intravenous infusion every 3 weeks.

Eligibility Criteria

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

You may qualify if:

• Phase I Study
• Each subject must meet the following criteria to be enrolled in this study.
• Pathologically confirmed adenocarcinoma of the breast with metastasis.
• No more than 2 prior chemotherapy regimen for metastatic breast cancer. Patient should have received anthracycline and may have received a taxane but not within 6 months for registration on the study.
• Patient may have measurable or evaluable disease.
• Patient may have non-measurable bone only disease.
• At least 4 weeks since prior cytotoxic chemotherapy. Patients should have recovered from all acute effects of such therapy.
• At least 4 weeks since radiotherapy, with full recovery.
• At least 4 weeks since recovery from major surgery, with full recovery.
• ECOG performance status 0-2.
• Age ≥18 years.
• Patient must have the following blood counts at Baseline:
• WBC \> 3.0 x 109 cells/L;
• ANC ≥ 1.5 x 109 cells/L;
• Platelets ≥ 100 x 109 cells/L;

You may not qualify if:

• Phase I Study
• Subjects who meet any of the following criteria will be excluded from the study.
• Concurrent therapy (chemotherapy, hormonal therapy, kinase inhibitors, immunotherapy, etc) for breast cancer. Bisphosphonates are allowed.
• Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris or recent myocardial infarction (within the last 6 months).
• History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer excluding non-melanomatous skin cancer and cervical carcinoma in situ.
• Patients who have received an investigational drug within the previous 4 weeks.
• Patient is currently enrolled in any other clinical study in which investigational procedures are performed or investigational therapies are administered. A patient may not enroll in such clinical trials while participating in this study.
• Pregnant or nursing women.
• Patients with history of allergic reactions attributed to solvent-based docetaxel(Taxotere).
• ECOG performance status 3-4.
• Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with docetaxel. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
• Phase II Study
• Subjects who meet any of the following criteria will be excluded from the study.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Nuhad Ibrahim, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 14, 2007
• First Posted: September 18, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: November 14, 2019

Record last verified: 2019-11

Locations

US (1)