- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00122343
AP23573 in Female Adult Patients With Recurrent or Persistent Endometrial Cancer (8669-019)(COMPLETED)
February 18, 2015 updated by: Merck Sharp & Dohme LLC
A Phase II Study of AP23573, an mTOR Inhibitor, in Female Adult Patients With Recurrent or Persistent Endometrial Cancer
This is an open-label nonrandomized multi-center study designed to evaluate the effect of AP23573 in patients with recurrent or persistent endometrial cancer.
The primary objective 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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
AP23573 will be administered intravenously (IV) at a fixed dose of 12.5 mg over 30 minutes once daily for 5 days (QDx5) every 2 weeks.
A 4-week period comprised of 2 courses of AP23573 is defined as a cycle of treatment.
|
AP23573 will be administered intravenously (IV) at a fixed dose of 12.5 mg over 30 minutes once daily for 5 days (QDx5) every 2 weeks.
A 4-week period comprised of 2 courses of AP23573 is defined as a cycle of treatment.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: Duration of the study
|
Duration of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assess the safety and tolerability of this study drug regimen in this patient population
Time Frame: Duration of the study
|
Duration of the study
|
Evaluate secondary efficacy endpoints of time to tumor progression, progression-free survival and duration of response
Time Frame: Duration of the study
|
Duration of the study
|
Examine pharmacokinetic characteristics of AP23573
Time Frame: Duration of the study
|
Duration of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Frank Haluska, M.D., Ph.D., Ariad Pharmaceuticals
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
July 21, 2005
First Submitted That Met QC Criteria
July 21, 2005
First Posted (Estimate)
July 22, 2005
Study Record Updates
Last Update Posted (Estimate)
February 19, 2015
Last Update Submitted That Met QC Criteria
February 18, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Endometrial Neoplasms
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- 8669-019
- AP23573-04-203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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