Recurrent Endometrial CarcinomaNCT02093546
Biospecimen Collection in Assessing the Effect of Trametinib With or Without Uprosertib on Biomarkers in Patients With Persistent or Recurrent Endometrial Cancer Enrolled on Trial GOG02290
An observational study of Recurrent Endometrial Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial assesses blood and tumor samples for the effect of trametinib with or without uprosertib on biomarkers in patients enrolled on trial GOG02290 with endometrial cancer that is persistent or has come back. Biomarkers found in the blood and tissue may be related to the reaction or response to the study drugs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Recurrent Endometrial Carcinoma
- What is being tested?
- Biospecimen Collection
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2004to 15 Jan 2020
- Phase
- Observational
- 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
Study population: MDACC Participants
Who may be able to join
- Patients must be enrolled on GOG0229O
- Patients must have tissue available for molecular analysis. This can be tissue obtained at time of current recurrence or archival tissue from primary diagnosis or recurrence
- Patients must have disease lesions that are amenable to pre- and post- treatment biopsy
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
Who cannot join
- Patients unwilling to undergo a biopsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Translational Companion Protocol to GOG229O: A Randomized Phase II Study With a Safety Lead-In to Assess the Antitumor Efficacy of the MEK Inhibitor Trametinib Alone or in Combination With GSK2141795, an AKT Inhibitor, in Patients With Recurrent or Persistent Endometrial Cancer
This trial assesses blood and tumor samples for the effect of trametinib with or without uprosertib on biomarkers in patients enrolled on trial GOG02290 with endometrial cancer that is persistent or has come back. Biomarkers found in the blood and tissue may be related to the reaction or response to the study drugs.
Read the detailed description
PRIMARY OBJECTIVES:
- To explore the impact of trametinib alone or in combination with uprosertib (GSK2141795) on RAF-MEK-ERK and PI3K pathway signaling.
SECONDARY OBJECTIVES:
- To examine associations with early changes in functional proteomic biomarkers in tumor biopsies before and after treatment and tumor response in two subgroups of patients with recurrent or persistent endometrial cancer who are treated with trametinib alone or in combination with GSK2141795.
II. To examine levels of circulating tumor cells in blood samples before and after treatment and correlate with tumor response in two subgroups of patients with recurrent or persistent endometrial cancer who are treated with trametinib alone or in combination with GSK2141795.
III. To examine the bRaf/cRaf dimer or Raf/KSR/Mek1 dimers in paraffin sections from these patients before treatment by proximity ligation assay (PLA) assays.
IV. To quantify exosomes from these patients before and after treatment by enzyme-linked immunosorbent assay (ELISA) assay with CD63 antibody and explore bRaf/cRaf dimer or Raf/KSR/Mek1 dimers in exosomes from these patients before and after treatment by PLA assays.
OUTLINE:
Patients undergo collection of blood at screening, between days 3 and 5, 28, and 56. Patients also undergo collection of tumor biopsy at screening and day 28.
- Conditions
- Recurrent Endometrial Carcinoma
- Being tested
- Biospecimen Collection
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood and tumor
| Study group | Role | What they receive |
|---|---|---|
| Ancillary-correlative (Biospecimen collection) | Patients undergo collection of blood at screening, between days 3 and 5, 28, and 56. Patients also undergo collection of tumor biopsy at screening and day 28. Receives: Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in biomarker expression
Will use descriptive statistics and graphical methods to compare pre-treatment to post-treatment changes in biomarker expression between patients with and without each type of response for each treatment arm and subgroup. Will estimate mean changes from pre-treatment to each post-treatment assessment with 95% confidence intervals. will use a 2-sample t-test to compare treatment arms with respect to the mean change in biomarker expression. Will use a 2-sample Wilcoxon rank sum test to compare treatment arms with respect to the median change in biomarker expression. This testing may also be restricted to specific subgroups (e.g., patients with complete response), depending on the characteristics of patients accrued. Will also use regression methods to model the change in biomarker expression with time and type of response.
Measured: Pre-treatment to post-treatment
Secondary outcomes (1)
Circulating tumor cells (CTCs) levels
Will use descriptive statistics and graphical methods to compare the numbers of circulating tumor cells (CTCs) over time for patients with and without each type of response for each treatment arm and subgroup. Will estimate with 95% confidence intervals the mean number of CTCs at each assessment time for patients with and without each type of response for each treatment arm and subgroup.
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study start13 Aug 2004
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Observational
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Shannon Westin, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093546
- Sponsor's protocol ID
- 2013-1029
- Other IDs
- NCI-2018-02663, 2013-1029, P30CA016672
- Status last verified
- Jan 2020
- First submitted
- 17 Mar 2014
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Translational Companion Protocol to GOG229O: A Randomized Phase II Study With a Safety Lead-In to Assess the Antitumor Efficacy of the MEK Inhibitor Trametinib Alone or in Combination With GSK2141795, an AKT Inhibitor, in Patients With Recurrent or Persistent Endometrial Cancer
- ClinicalTrials.gov ID
- NCT02093546
- Acronym / sponsor ID
- 2013-1029
- Conditions
- Recurrent Endometrial Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Aug 2004 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 21 Mar 2014 (estimated)
- 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 trial assesses blood and tumor samples for the effect of trametinib with or without uprosertib on biomarkers in patients enrolled on trial GOG02290 with endometrial cancer that is persistent or has come back. Biomarkers found in the blood and tissue may be related to the reaction or response to the study drugs.
Detailed description
PRIMARY OBJECTIVES:
- To explore the impact of trametinib alone or in combination with uprosertib (GSK2141795) on RAF-MEK-ERK and PI3K pathway signaling.
SECONDARY OBJECTIVES:
- To examine associations with early changes in functional proteomic biomarkers in tumor biopsies before and after treatment and tumor response in two subgroups of patients with recurrent or persistent endometrial cancer who are treated with trametinib alone or in combination with GSK2141795.
II. To examine levels of circulating tumor cells in blood samples before and after treatment and correlate with tumor response in two subgroups of patients with recurrent or persistent endometrial cancer who are treated with trametinib alone or in combination with GSK2141795.
III. To examine the bRaf/cRaf dimer or Raf/KSR/Mek1 dimers in paraffin sections from these patients before treatment by proximity ligation assay (PLA) assays.
IV. To quantify exosomes from these patients before and after treatment by enzyme-linked immunosorbent assay (ELISA) assay with CD63 antibody and explore bRaf/cRaf dimer or Raf/KSR/Mek1 dimers in exosomes from these patients before and after treatment by PLA assays.
OUTLINE:
Patients undergo collection of blood at screening, between days 3 and 5, 28, and 56. Patients also undergo collection of tumor biopsy at screening and day 28.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ancillary-correlative (Biospecimen collection) | – | Procedure: Biospecimen CollectionPatients undergo collection of blood at screening, between days 3 and 5, 28, and 56. Patients also undergo collection of tumor biopsy at screening and day 28. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MDACC Participants
Key inclusion criteria (4 listed)
- Patients must be enrolled on GOG0229O
- Patients must have tissue available for molecular analysis. This can be tissue obtained at time of current recurrence or archival tissue from primary diagnosis or recurrence
- Patients must have disease lesions that are amenable to pre- and post- treatment biopsy
- Patients must have signed an approved informed consent and authorization permitting release of personal health information
Key exclusion criteria (1 listed)
- Patients unwilling to undergo a biopsy
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 |
|---|---|---|
| Biospecimen CollectionUndergo collection of blood and tumor | Procedure or surgery | Ancillary-correlative (Biospecimen collection) |
Primary outcome
Change in biomarker expression
Time frame: Pre-treatment to post-treatment
Will use descriptive statistics and graphical methods to compare pre-treatment to post-treatment changes in biomarker expression between patients with and without each type of response for each treatment arm and subgroup. Will estimate mean changes from pre-treatment to each post-treatment assessment with 95% confidence intervals. will use a 2-sample t-test to compare treatment arms with respect to the mean change in biomarker expression. Will use a 2-sample Wilcoxon rank sum test to compare treatment arms with respect to the median change in biomarker expression. This testing may also be restricted to specific subgroups (e.g., patients with complete response), depending on the characteristics of patients accrued. Will also use regression methods to model the change in biomarker expression with time and type of response.
1 secondary outcome
Circulating tumor cells (CTCs) levels
Time frame: Up to 15 years
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 28 Jan 2020.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Shannon Westin principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Endometrial Carcinoma, run by M.D. Anderson Cancer 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 4 inclusion and 1 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 28 Jan 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.
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?
Change in biomarker expression (time frame: Pre-treatment to post-treatment). 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 28 Jan 2020.