Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation

NCT03285802 | Completed Phase 2 FDA Drug

• 1 other identifier: CRAD001X2401
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label treatment program following basic prescribing information for patients with recurrent UPSC (Uterine Papillary Serous Carcinoma) to provide access to everolimus and limited treatment alternatives.

Conditions

Uterine Cancer

Outcome Measures

Primary Outcomes (1)

• Single Arm Trial With Combination of Everolimus and Letrozole in Treatment With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation; Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria

  Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria

  Baseline, Then every 12 weeks while on Everolimus and Letrozole up to 36 months;

Secondary Outcomes (1)

• Single Arm Trial With Combination of Everolimus and Letrozole in Treatment With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation; Overall survival of patients treated with the combination of letrozole and everolimus

  From randomization until date of death, assessed up to 36 months

Study Arms (1)

Letrozole and Everolimus

EXPERIMENTAL

Letrozole 2.5mg daily q 30 days Everolimus 10mg daily q 28 days

Drug: Letrozole; Drug: Everolimus

Interventions

Letrozole DRUG

Letrozole 2.5mg will be taken daily q 30 days

Also known as: Femara

Letrozole and Everolimus

Everolimus DRUG

Everolimus 10mg daily q 28 days

Also known as: Afinitor

Letrozole and Everolimus

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has adequate bone marrow and coagulation function as shown by: absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelets ≥ 100 × 109/L; hemoglobin (Hgb) ≥ 9.0 g/dL.
• Patient has adequate liver function as shown by:
• total serum bilirubin ≤2.0 mg/dL,
• ALT and AST ≤2.5x ULN (≤5x ULN in patients with liver metastases),
• INR ≤2;.
• Patient has adequate renal function as shown by serum creatinine ≤ 1.5 × ULN.
• Patient has fasting serum cholesterol ≤ 300mg/dl or 7.75mmol/L AND fasting triglycerides ≤ 2.5 × ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can only be included after initiation of appropriate lipid lowering medication.
• Patient will give a written informed consent obtained according to local guidelines.
• Sexually active males must use a condom during intercourse while taking everolimus for treatment, for 8 weeks after stopping treatment, or their female partners should use highly effective contraception during this specified time period.
• Women of childbearing potential must have had a negative serum pregnancy test 14 days prior to the start of everolimus treatment plus a negative local urine pregnancy test prior to treatment and must be willing to use highly effective methods of contraception during the study and for 8 weeks after study drug administration.

You may not qualify if:

• Patient has had prior therapy with mTOR inhibitors (e.g. sirolimus, temsirolimus, deforolimus).
• Patient has a known intolerance or hypersensitivity to everolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus).
• Patient has uncontrolled diabetes mellitus as defined by fasting serum glucose \> 1.5 × ULN despite adequate therapy. Patients with a known history of impaired fasting glucose or diabetes mellitus (DM) may be included, however blood glucose and antidiabetic treatment must be monitored closely throughout participation in the program and adjusted as necessary.
• Patient has any severe and/or uncontrolled medical conditions such as:
• unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to randomization, serious uncontrolled cardiac arrhythmia,
• active or uncontrolled severe infection,
• liver disease such as cirrhosis, decompensated liver disease, and chronic hepatitis (i.e. quantifiable HBV-DNA and/or positive HbsAg, quantifiable HCV-RNA),
• known severely impaired lung function (spirometry and DLCO 50% or less of normal and O2 saturation 88% or less at rest on room air),
• active, bleeding diathesis.
• Chronic treatment with corticosteroids or other immunosuppressive agents.
• Patient has a known history of HIV seropositivity.
• Patient is a woman of child-bearing potential, unless she is using highly effective contraception methods.
• Women of child-bearing potential (WOCBP) is defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partner has been sterilized by vasectomy or other means.
• Highly effective contraception, defined as one that results in an annual pregnancy rate \<1% when used correctly, comprises one of the following methods:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception)

Sponsors & Collaborators

• Greater Baltimore Medical Center: lead

Study Sites (1)

Greater Baltimore Medical Center

Baltimore, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Uterine Neoplasms

Interventions

Letrozole; Everolimus

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sirolimus; Macrolides; Lactones

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologic Oncologist

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 18, 2017
• Study Start: September 7, 2017
• Primary Completion: February 12, 2019
• Study Completion: February 12, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

US (1)