Uterine CancerPhase 2/3NCT03285802
Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation
A Phase 2/3 study testing Letrozole and Everolimus in people with Uterine Cancer, run by Greater Baltimore Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cancer
- What is being tested?
- Letrozole and Everolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2017to 12 Feb 2019
- Phase
- Phase 2/3
- 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
- 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.
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- 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.
Who cannot join
- 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,
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- 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)
- Male/female sterilization
- Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception
- Patient is unwilling to or unable to comply with the treatment plan.
Trial locations and contacts
1 site in 1 country.
United States1 site
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
About this study
Official title: CRAD001X2401: Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation
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.
Read the detailed description
The objective is to provide access to everolimus for patients with Recurrent UPSC and limited treatment alternatives.
Letrozole 2.5mg daily q 30 days Everolimus 10mg daily q 28 days
- Conditions
- Uterine Cancer
- Being tested
- Letrozole, Everolimus
- Medical subject headings
- Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called Femara
Letrozole 2.5mg will be taken daily q 30 days
EverolimusDrug
Also called Afinitor
Everolimus 10mg daily q 28 days
| Study group | Role | What they receive |
|---|---|---|
| Letrozole and Everolimus | Experimental | Letrozole 2.5mg daily q 30 days Everolimus 10mg daily q 28 days Receives: Drug: Letrozole; Drug: Everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Overall survival of patients treated with the combination of letrozole and everolimus
Measured: From randomization until date of death, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start7 Sep 2017
- Primary completion12 Feb 2019
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greater Baltimore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Loomis, CCRP, Greater Baltimore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285802
- Sponsor's protocol ID
- CRAD001X2401
- Status last verified
- Feb 2020
- First submitted
- 7 Sep 2017
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRAD001X2401: Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation
- ClinicalTrials.gov ID
- NCT03285802
- Acronym / sponsor ID
- CRAD001X2401
- Conditions
- Uterine Cancer
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Greater Baltimore Medical CenterUniversity, hospital or other
- Study start
- 7 Sep 2017 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective is to provide access to everolimus for patients with Recurrent UPSC and limited treatment alternatives.
Letrozole 2.5mg daily q 30 days Everolimus 10mg daily q 28 days
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Letrozole and Everolimus | Experimental | Drug: Letrozole, Drug: EverolimusLetrozole 2.5mg daily q 30 days Everolimus 10mg daily q 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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.
Key exclusion criteria (18 listed)
- 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:
- Chronic treatment with corticosteroids or other immunosuppressive agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetrozoleAlso: FemaraLetrozole 2.5mg will be taken daily q 30 days | Drug | Letrozole and Everolimus |
| EverolimusAlso: AfinitorEverolimus 10mg daily q 28 days | Drug | Letrozole and Everolimus |
Primary outcome
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
Time frame: Baseline, Then every 12 weeks while on Everolimus and Letrozole up to 36 months;
Tumor Response to treatment with Everolimus and Letrozole using RECIST Criteria
1 secondary outcome
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
Time frame: From randomization until date of death, assessed up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Letrozole and Everolimus in people with Uterine Cancer, run by Greater Baltimore Medical Center at 1 site in United States.
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 10 inclusion and 18 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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 (time frame: Baseline, Then every 12 weeks while on Everolimus and Letrozole up to 36 months;). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.