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Hormone Refractory Prostate CancerPhase 1/2NCT00477529

ABI-008 Trial in Patients With Hormone-refractory Prostate Cancer

A Phase 1/2 study testing ABI-008 in people with Hormone Refractory Prostate Cancer, run by Celgene at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of ABI-008 given 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Hormone Refractory Prostate Cancer
What is being tested?
ABI-008
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
4 sitesUnited States
Study dates
1 Apr 2007to 2 Jun 2011
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Each subject must meet the following criteria to be enrolled in this study.
  • Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate that is clinically refractory to hormone therapy.
  • Zubrod Performance Status 0-1.
  • At the time of enrollment, patients must have evidence of progressive metastatic disease, either:
  • Measurable disease with any level of serum PSA
  • OR
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  • Non-measurable disease with PSA ≥ 5 ng/ml. Patients with PSA ≥ 5 ng/ml only and no other radiographic evidence of metastatic prostate cancer are not eligible.
  • Patients must have demonstrated evidence of progressive disease since the most recent change in therapy. Progressive disease is defined as any one of the following (measurable disease, bone scan, or PSA progression):
  • Measurable Disease Progression
  • Bone Scan Progression
  • PSA Progression
  • Serum testosterone ≤ 50 ng/ml, determined within two weeks prior to starting treatment.
  • Maintaining castrate status: Patients who have not undergone surgical orchiectomy should continue on medical therapies [e.g. gonadotropin releasing hormone analogs (GnRH analogs)] to maintain castrate levels of serum testosterone.
  • Megestrol acetate (MEGACE®) treatment may continue if patient has been on stable doses of the drug.
  • Age > 18 years of age.
  • Four weeks since major surgery.
  • The following restrictions on prior therapy for metastatic disease apply:
  • No prior chemotherapy regimen for metastatic disease.
  • No more than one prior course of palliative radiotherapy.
  • Up to one prior treatment with a non-chemotherapeutic agent (e.g., kinase inhibitors, immunotherapeutic agents, etc) is permitted as treatment for metastatic disease.
  • No prior radioisotope therapy with Strontium-89, Samarium or similar agents.
  • One prior neo-adjuvant or adjuvant chemotherapy regimen is permitted if given over 3 years ago.
  • No limitation on prior hormonal therapy.
  • Patients should be off all therapy for at least 4 weeks prior to study drug administration.
  • Life expectancy should be ≥ 3 months.
  • Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.
  • Required Initial Laboratory Data:
  • WBC ≥ 3,000/µl
  • ANC ≥ 1,500/µl
  • Platelet count ≥ 100,000/µl
  • Creatinine ≤ 1.5 x
  • Total Bilirubin ≤ (exceptions will be made for patients with Gilbert's Disease)
  • SGOT (AST) ≤ 1.5 x
  • SGPT (ALT) ≤ 1.5 x
  • Men whose sexual partners are of child-bearing age must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of study participation.
  • If obese (weight > 20% of ideal body weight) patient must be treated with doses calculated using adjusted BSA.

Who cannot join

  • Subjects who meet any of the following criteria will be excluded from the study.
  • Patients may not be receiving any other investigational agents.
  • Patients may continue on a daily Multi-Vitamin, low dose (≤ 400 IU qd) Vitamin D, Calcitrol (≤ 0.5 mcg qd), and calcium supplements, but all other herbal, alternative and food supplements (i.e. PC-Spes, Saw Palmetto, St John Wort, etc.) must be discontinued before registration.
  • Patients on stable doses of bisphosphonates, who develop subsequent tumor progression, may continue on this medication.However, patients may not initiate bisphosphonate therapy prior to or during study
  • Patients with known brain metastases.
  • Patients with history of allergic reactions attributed to solvent-based docetaxel (Taxotere).
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  • Patients with significant cardiovascular disease including congestive heart failure, active angina pectoris or recent myocardial infarction (within the last 6 months).
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers.
  • 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.
  • HIV-positive patients receiving combination anti-retroviral therapy.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • University of Texas M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of ABI-008 given 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.

Read the detailed description

Detailed description not necessary.

Being tested
ABI-008

What participants receive

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

  • ABI-008Drug

    Also called nab-docetaxel

    nab-docetaxel

Study groups in NCT00477529
Study groupRoleWhat they receive
ABI-008ExperimentalNot described
Receives: Drug: ABI-008

What is being measured

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

  1. DLT's and MTD's

    Measured: 1 Year

Secondary outcomes (1)

  1. Efficacy of ABI-008 in this patient population

    Measured: Q12 weeks and 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 posted23 May 2007 (estimated)
  2. Study start1 Apr 2007
  3. Primary completion2 Jun 2011
  4. Study completion2 Jun 2011

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00477529
Sponsor's protocol ID
CA301
Status last verified
Nov 2019
First submitted
21 May 2007
Last updated
22 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 in people with Hormone Refractory Prostate Cancer, run by Celgene at 4 sites 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 36 inclusion and 10 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: finished, as of the sponsor's last update on 22 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 4 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

DLT's and MTD's (time frame: 1 Year). 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 NCT00477529.

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 22 Nov 2019.

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