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
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cervical Cancer, Cancer, Endometrial Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/24/2018 |
| Start Date: | August 13, 2004 |
| End Date: | August 31, 2019 |
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.
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.
PRIMARY OBJECTIVES:
I. To explore the impact of trametinib alone or in combination with uprosertib (GSK2141795)
on RAF-MEK-ERK and PI3K pathway signaling.
SECONDARY OBJECTIVES:
I. 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.
I. To explore the impact of trametinib alone or in combination with uprosertib (GSK2141795)
on RAF-MEK-ERK and PI3K pathway signaling.
SECONDARY OBJECTIVES:
I. 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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients unwilling to undergo a biopsy
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