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A Phase II Study of AP23573, an mTOR Inhibitor, in Female Adult Patients With Recurrent or Persistent Endometrial Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

A Phase II Study of AP23573, an mTOR Inhibitor, in Female Adult Patients With Recurrent or Persistent Endometrial Cancer


Inclusion Criteria:



- ≥18 years of age with histologically confirmed endometrial cancer

- Documented progression of endometrial cancer (e.g., within the last 3 months)

- If of childbearing potential, must agree to use approved barrier methods of
contraception (non hormonal methods)

- Presence of at least one measurable lesion that can be accurately measured in at
least one dimension with longest diameter ≥20 mm using conventional techniques or ≥10
mm with spiral computed tomography (CT) scan (or otherwise at least twice the
reconstruction interval for CT or magnetic resonance imaging [MRI] scans). Previously
irradiated lesions may be considered to be measurable provided: *there has been
documented progression of the lesion(s) since completion of radiotherapy; and *the
criteria for measurability as outlined above are met.

- ECOG performance status ≤ 2

- Minimum life expectancy of 3 months

- Adequate renal and hepatic function, defined as:

- Total serum bilirubin ≤ 1.5 x ULN for the institution;

- AST and/or ALT ≤ 2 x ULN for the institution;

- Alkaline phosphatase < 1.5 x ULN for the institution (if > 1.5 x ULN, then
alkaline phosphatase liver fraction must be < 1.5 ULN);

- Serum albumin ≥ 2.5 g/dL;

- Serum creatinine ≤ 1.5 x ULN for the institution.

- 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

- Able to understand and give written informed consent

Exclusion Criteria:

- Women who are pregnant or lactating

- Presence of brain metastases

- More than 2 prior regimens of cytotoxic chemotherapy or enzyme inhibitor therapy

- Prior therapy with rapamycin, rapamycin analogues or tacrolimus; or known sensitivity
to these agents

- Anticancer treatment (chemotherapy, radiotherapy, immunotherapy, biological response
modifiers, signal transduction inhibitors, etc.) within 4 weeks prior to the first
dose of AP23573. The interval may be ≥ 2 weeks for hormonal therapy or signal
transduction inhibitors with a half-life known to be <24 hours and must be ≥ 6 weeks
for nitrosourea or mitomycin.

- Ongoing toxicity associated with prior anticancer therapy (except peripheral
neuropathy of ≤ Grade 1 by National Cancer Institute [NCI] toxicity criteria)

- Another primary malignancy within the past three years (except for non-melanoma skin
cancer and cervical carcinoma in situ)

- 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
AP23573

- Concurrent treatment with immunosuppressive agents other than prescribed
corticosteroids at stable doses for ≥ 2 weeks prior to first planned dose of study
drug. Nasal, ophthalmic, and topical glucocorticoid preparations are allowed as
well as low dose maintenance steroid therapy for other conditions. Physiologic
hormone replacement therapy (e.g., thyroid supplementation for thyroid deficiency or
oral replacement glucocorticoid therapy for adrenal insufficiency) is allowed.

- Inadequate recovery from any prior surgical procedure or having undergone any major
surgical procedure within 2 weeks prior to the first dose of AP23573. Patients who
have recovered from placement of a central venous access port within 2 weeks of Cycle
1, Day 1 will be considered eligible.

- 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:

Interventional

Study Design:

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

Outcome Measure:

The primary objective of the study is to assess the efficacy of AP23573 in patients with recurrent or persistent endometrial cancer when administered once daily for 5 consecutive days (QDx5) every two weeks at a dose of 12.5 mg/day.

Outcome Time Frame:

Duration of the study

Safety Issue:

No

Principal Investigator

Frank Haluska, M.D., Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Ariad Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

AP23573-04-203

NCT ID:

NCT00122343

Start Date:

July 2005

Completion Date:

January 2008

Related Keywords:

  • Endometrial Cancer
  • Endometrial
  • Cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Montefiore Medical CenterBronx, New York  10467-2490
University of ChicagoChicago, Illinois  60637
Hematology and Oncology Specialists, LLCNew Orleans, Louisiana  70115
Indiana UniversityIndianapolis, Indiana  46202
Florida HospitalOrlando, Florida  32803
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Yale University New Haven Medical CenterNew Haven, Connecticut  06510