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A Phase II Study of the Efficacy and Safety of AP23573 in Patients With Taxane-Resistant Androgen-Independent Prostate Cancer (AIPC)

Phase 2
18 Years
Not Enrolling
Prostate Cancer

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Trial Information

A Phase II Study of the Efficacy and Safety of AP23573 in Patients With Taxane-Resistant Androgen-Independent Prostate Cancer (AIPC)

The primary objective of this phase II study is to assess the anti-cancer activity of weekly
AP23573 administration in patients with taxane-resistant AIPC. Other objectives include
evaluating experimental parameters that may predict or indicate response to mTOR inhibition,
such as effects on plasma VEGF, markers of tumoral PI3K/mTOR-pathway activity, and proteomic
analysis. The inclusion of these evaluations in this trial may provide insight into the
identification of markers that may be helpful in optimizing AP23573 treatment and in
identifying patients with AP23573-sensitive tumors.

Inclusion Criteria:

- Male patients aged ≥ 18 years with histologically documented adenocarcinoma of the

- Clinically refractory to hormone therapy (orchiectomy or luteinizing
hormone-releasing hormone agonist/antagonist).

- Presence of metastatic prostate cancer that fulfills at least one evaluation category
as listed: * Measurable Disease: Lesion(s) that can be accurately measured in at
least one dimension with the longest diameter ≥ 20 mm using conventional techniques
or ≥ 10 mm with spiral CT scan (or otherwise at least twice the reconstruction
interval for CT or MRI scans). *Non-measurable disease: Lesions noted on imaging
studies (including metastatic bone lesions on bone scan) or other non-measurable
lesions as defined by the modified RECIST criteria. *Progressive disease following a
cytotoxic chemotherapy regimen for prostate cancer.

- Previous treatment with at least one taxane-containing chemotherapy regimen.
Patients may have received treatment with not more than 3 additional regimens of
cytotoxic chemotherapy prior to study entry.

- Orchiectomy, or castrate levels of testosterone maintained by LHRH agonist/antagonist
< 50 ng/mL.

- Predicted life expectancy > 12 weeks.

- ECOG PS ≤ 2.

- Adequate renal and hepatic function, defined as: *Total serum bilirubin ≤ 1.5 x ULN
for the institution; *AST and/or ALT ≤ 3 x ULN for the institution (≤ 5 x ULN if
liver metastases are present); *Serum albumin ≥ 2.5 g/dL; *Serum creatinine ≤1.5 x
ULN for the institution (or a calculated creatinine clearance ≥ 50 mL/min/1.73m2)

- Adequate bone marrow function, defined as: *ANC ≥ 1.5 x 10^9/L; *Platelet count ≥
100 x 10^9/L

- Serum cholesterol < 350 mg/dL and triglycerides < 400 mg/dL.

- Male patients who are not surgically sterile must agree to use reliable methods of
birth control for the duration of the study until 30 days after the last dose of
study drug.

- Able to understand and give written informed consent.

Exclusion Criteria:

- Presence of active or progressive brain metastases.

- Prior therapy with rapamycin, rapamycin analogues or tacrolimus.

- Prior non-hormonal anticancer treatment (chemotherapy, radiotherapy, immunotherapy,
biological response modifiers, signal transduction inhibitors, etc.) within 4 weeks
prior to the first dose of AP23573

- Ongoing toxicity associated with prior anticancer therapy (except peripheral
neuropathy of ≤ grade 1 by NCI toxicity criteria).

- Another primary malignancy within the past three years (except for non-melanoma skin

- Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween)
or any other excipient contained in the study drug.

- Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin,
erythromycin, azithromycin).

- Significant uncontrolled cardiovascular disease.

- Active infection requiring systemic therapy.

- Known HIV infection.

- Treatment with any investigational agent within 4 weeks prior to the first dose of

- Concurrent treatment with immunosuppressive agents other than prescribed
corticosteroids at stable doses for ≥ 2 weeks prior to first planned dose of study

- Inadequate recovery from any prior surgical procedure or having undergone any major
surgical procedure within 2 weeks prior to the first dose of AP23573.

- Presence of any other life-threatening illness or organ system dysfunction which, in
the opinion of the Investigator, would either compromise the patient's safety or
interfere with evaluating the safety of the study drug.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess the antitumor activity of weekly AP23573 study treatment in patients with taxane-resistant AIPC.

Outcome Time Frame:

Duration of the study

Safety Issue:


Principal Investigator

Frank Haluska, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ariad Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

May 2005

Completion Date:

September 2008

Related Keywords:

  • Prostate Cancer
  • prostate
  • cancer
  • Prostatic Neoplasms



Louis Warchaw Prostate Cancer Center, Cedars-Sinai Medical Center Los Angeles, California  90048
Beth Israel Deaconess Medical Center/MGH/DFCI Boston, Massachusetts  02215
The Methodist Hospital Research Institute Houston, Texas  77030
University of Wisconsin, Madison, WI Madison, Wisconsin  53792