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Metastatic Breast CancerPhase 1/2NCT00531271

ABI-008 Trial in Patients With Metastatic Breast Cancer

A Phase 1/2 study testing ABI-008 (nab-docetaxel) in people with Metastatic Breast Cancer, run by Celgene at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
ABI-008 (nab-docetaxel)
Type of treatment
Injection or infusion
How many people
85 participants
Where
1 siteUnited States
Study dates
1 Nov 2007to 1 Dec 2008
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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;
  • Hgb ≥ 9 grams/dL.
  • Patient has the following blood chemistry levels at Baseline:
  • AST (SGOT), ALT (SGPT) ≤ 1.5x upper limit of normal range (ULN);
  • Total Bilirubin < ULN;
  • Alkaline phosphatase ≤ 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis);
  • Creatinine ≤ 1.5 mg/dL.
  • Peripheral neuropathy Grade 0 or stable Grade 1, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0.
  • If female of childbearing potential, serum pregnancy test is negative (within 72 hours of the first dose of study drug).
  • If fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.
  • Life expectancy should be ≥ 3 months.
  • Informed consent document has been obtained stating that the patient understands the investigational nature of the proposed treatment.
  • If obese, a patient must be treated with doses calculated using his/her actual body surface area (BSA) (the physician must be comfortable treating at the full BSA dose regardless of BSA).
  • Phase II Study
  • Pathologically confirmed adenocarcinoma of the breast with metastasis.
  • Patients should have not received prior chemotherapy for their metastatic disease. If a taxane is used as adjuvant or neoadjuvant therapy, at least 12 months should have elapsed from the date of the last dose.
  • Patient must have at least one measurable metastatic lesion.
  • 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 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;
  • Hgb ≥ 9 grams/dL.
  • Patient has the following blood chemistry levels at Baseline:
  • AST (SGOT), ALT (SGPT) ≤ 1.5x upper limit of normal range (ULN);
  • Total Bilirubin < ULN;
  • Alkaline phosphatase ≤ 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis);
  • Creatinine ≤ 1.5 mg/dL.
  • Peripheral neuropathy Grade 0 or stable Grade 1, by NCI CTCAE v3.0.
  • If female of childbearing potential, serum pregnancy test is negative (within 72 hours of the first dose of study drug).
  • If fertile, the patient agrees to use an effective method to avoid pregnancy for the duration of the study.
  • Life expectancy should be ≥ 3 months.
  • Informed consent document has been obtained stating that the patient understands the investigational nature of the proposed treatment.

Who cannot join

  • 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).
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  • 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.
  • Prior neo-adjuvant or adjuvant chemotherapy is allowed. If a taxane was part of the adjuvant regimen, at least 12 months should have transpired since completion of taxane regimen.
  • Concurrent therapy (chemotherapy, hormonal therapy, kinase inhibitors, immunotherapy, etc) for breast cancer.
  • 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 4weeks.
  • Patient is currently enrolled in any other clinical study in which investigational procedures are performed or investigational therapies are administered.
  • 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.
  • Patients with tumor overexpression of HER2/neu.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase I/II Trial of ABI-008 (Nab-docetaxel) in Patients With Metastatic Breast Cancer

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.

Being tested
ABI-008 (nab-docetaxel)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABI-008 (nab-docetaxel)Drug

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: End of Study (EOS) and Follow Up

Secondary outcomes (1)

  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.

    Measured: End of Study (EOS) and Follow Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2007 (estimated)
  2. Study start1 Nov 2007
  3. Primary completion1 Dec 2008
  4. Study completion1 Dec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00531271
Sponsor's protocol ID
CA302
Status last verified
Nov 2019
First submitted
14 Sep 2007
Last updated
14 Nov 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ABI-008 (nab-docetaxel) in people with Metastatic Breast Cancer, run by Celgene at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 51 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) of ABI-008 giver every three weeks. (time frame: End of Study (EOS) and Follow Up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00531271.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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