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Endometrial CancerPhase 2NCT00122343

AP23573 in Female Adult Patients With Recurrent or Persistent Endometrial Cancer (8669-019)(COMPLETED)

A Phase 2 study testing ridaforolimus in people with Endometrial Cancer, run by Merck Sharp & Dohme LLC.

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

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrial Cancer
What is being tested?
ridaforolimus
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
No sites listed yet
Study dates
Aug 2005to Jan 2008
Phase
Phase 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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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
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  • 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

Who cannot join

  • 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)
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  • 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

About this study

Official title: 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.

Being tested
ridaforolimus
Keywords
Endometrial, Cancer
Medical subject headings
Endometrial Neoplasms, Neoplasms

What participants receive

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

  • ridaforolimusDrug

    Also called deforolimus, AP23573, MK-8669, ridaforolimus was also known as deforolimus until May 2009

    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.

Study groups in NCT00122343
Study groupRoleWhat they receive
1ExperimentalAP23573 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.
Receives: Drug: ridaforolimus

What is being measured

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

  1. 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.

    Measured: Duration of the study

Secondary outcomes (3)

  1. Assess the safety and tolerability of this study drug regimen in this patient population

    Measured: Duration of the study

  2. Evaluate secondary efficacy endpoints of time to tumor progression, progression-free survival and duration of response

    Measured: Duration of the study

  3. Examine pharmacokinetic characteristics of AP23573

    Measured: Duration of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionJan 2008
  4. Study completionJan 2008

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00122343
Sponsor's protocol ID
8669-019
Other IDs
AP23573-04-203
Status last verified
Feb 2015
First submitted
21 Jul 2005
Last updated
19 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • Colombo N, McMeekin DS, Schwartz PE, Sessa C, Gehrig PA, Holloway R, Braly P, Matei D, Morosky A, Dodion PF, Einstein MH, Haluska F. Ridaforolimus as a single agent in advanced endometrial cancer: results of a single-arm, phase 2 trial. Br J Cancer. 2013 Mar 19;108(5):1021-6. doi: 10.1038/bjc.2013.59. Epub 2013 Feb 12.

    PubMed 23403817

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ridaforolimus in people with Endometrial Cancer, run by Merck Sharp & Dohme LLC.

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 17 inclusion and 16 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 19 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

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?

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). 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 NCT00122343, which also lists 1 linked publication.

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 19 Feb 2015.

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Clinical Trial NCT00122343 | AzTrials