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

NCT00477529 | Completed Phase 1

• 1 other identifier: CA301
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hormone Refractory Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• DLT's and MTD's

  1 Year

Secondary Outcomes (1)

• Efficacy of ABI-008 in this patient population

  Q12 weeks and End of Study (EOS) and Follow Up

Study Arms (1)

ABI-008

EXPERIMENTAL

Drug: ABI-008

Interventions

ABI-008 DRUG

nab-docetaxel

Also known as: nab-docetaxel

ABI-008

Eligibility Criteria

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

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (4)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Study Officials

• John C Araujo, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 21, 2007
• First Posted: May 23, 2007
• Study Start: April 1, 2007
• Primary Completion: June 2, 2011
• Study Completion: June 2, 2011
• Last Updated: November 22, 2019

Record last verified: 2019-11

Locations

US (4)