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

NCT00122343 | Completed Phase 2

• 2 other identifiers: 8669-019AP23573-04-203
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief 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 consecutive days (QDx5) every two weeks at a dose of 12.5 mg/day.

Conditions

Endometrial Cancer

Keywords

Endometrial; Cancer

Outcome Measures

Primary Outcomes (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.

  Duration of the study

Secondary Outcomes (3)

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

  Duration of the study

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

  Duration of the study

• Examine pharmacokinetic characteristics of AP23573

  Duration of the study

Study Arms (1)

1

EXPERIMENTAL

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.

Drug: ridaforolimus

Interventions

ridaforolimus DRUG

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.

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

1

Eligibility Criteria

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

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Ariad Pharmaceuticals: collaborator

Related Publications (1)

• 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.

  PMID: 23403817 RESULT

MeSH Terms

Conditions

Endometrial Neoplasms; Neoplasms

Interventions

ridaforolimus

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Frank Haluska, M.D., Ph.D.

  Ariad Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2005
• First Posted: July 22, 2005
• Study Start: August 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: February 19, 2015

Record last verified: 2015-02