Endometrial Adenocarcinoma Clinical Trial
Official title:
A Phase II Evaluation of AZD6244 (NSC #748727) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
This phase II trial is studying how well selumetinib works in treating patients with recurrent or persistent endometrial cancer that has come back or is persistent. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To assess the activity of AZD6244 (selumetinib) for patients with recurrent or persistent
endometrial cancer with the frequency of patients who survive progression-free for at least 6
months after initiating therapy or have objective tumor response.
II. To determine the nature and degree of toxicity of AZD6244 as assessed by CTCAE v3.0 in
this cohort of patients.
SECONDARY OBJECTIVE:
I. To determine the duration of progression-free survival and overall survival.
EXPLORATORY OBJECTIVES:
I. To explore the associations between select biomarkers and response to AZD6244
(progression-free survival status >6 months and objective tumor response), measures of
clinical outcome (progression-free survival and overall survival) or disease status including
histologic cell type.
II. Mutations and single nucleotide polymorphisms in BRAF, KRAS2, FGFR2, PI3KCA, AKT1, AKT2,
AKT3 and PTEN in DNA from formalin-fixed and paraffin-embedded (FFPE) tumor and/or normal
blood cells.
III. Immunohistochemical expression of ERK, pERK, GSK3betta, pGSK3betta, PR-A, PR-B, pPR,
ER-alpha, ER-beta, BRAF, KRAS, PTEN, EGFR, pEGFR, EGF, PELP1 and MTA1s in FFPE tumor.
IV. To explore the relationship among the panel of biomarkers evaluated in this cohort
including mutations and single nucleotide polymorphisms in BRAF, KRAS2, FGFR2, PI3KCA, AKT1,
AKT2, AKT3 and PTEN as well as immunohistochemical expression of ERK, pERK, GSK3betta,
pGSK3betta, PR-A, PR-B, pPR, ER-alpha, ER-beta, BRAF, KRAS, PTEN, EGFR, pEGFR, EGF, PELP1 and
MTA1s.
OUTLINE: This is a multicenter study.
Patients receive selumetinib orally (PO) twice daily on days 1-28. Courses repeat every 28
days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor
tissue samples are collected for biomarker studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01935973 -
Trametinib With or Without GSK2141795 in Treating Patients With Recurrent or Persistent Endometrial Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT03660826 -
Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone
|
Phase 2 | |
| Active, not recruiting |
NCT04106414 -
Study of BMS-986205 and Nivolumab in Endometrial Cancer or Endometrial Carcinosarcoma That Has Not Responded to Treatment
|
Phase 2 | |
| Completed |
NCT01642082 -
Dalantercept in Treating Patients With Recurrent or Persistent Endometrial Cancer
|
Phase 2 | |
| Completed |
NCT01208467 -
Prognostic Biomarkers in Patients With Endometrial Cancer
|
N/A | |
| Completed |
NCT00025467 -
Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
|
Phase 2 | |
| Completed |
NCT01440998 -
Dasatinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV or Recurrent Endometrial Cancer
|
Phase 1 | |
| Completed |
NCT00006089 -
Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT00977574 -
Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
|
Phase 2 | |
| Recruiting |
NCT05001282 -
A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±)
|
Phase 1/Phase 2 | |
| Completed |
NCT01968317 -
Megestrol Acetate Plus Metformin to Megestrol Acetate in Patients With Endometrial Atypical Hyperplasia or Early Stage Endometrial Adenocarcinoma
|
Phase 2 | |
| Completed |
NCT01225887 -
Nintedanib in Treating Patients With Recurrent or Persistent Endometrial Cancer
|
Phase 2 | |
| Completed |
NCT01005329 -
Intensity-Modulated Radiation Therapy, Cisplatin, and Bevacizumab Followed by Carboplatin and Paclitaxel in Treating Patients Who Have Undergone Surgery for Endometrial Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02208375 -
mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian
|
Phase 1/Phase 2 | |
| Completed |
NCT03716414 -
Evaluation of the Efficacy for Sentinel Lymph Node Policy in High-risk Endometrial Carcinoma
|
||
| Withdrawn |
NCT03836157 -
Mirvetuximab Soravtansine (IMGN853) and Bevacizumab in Patients With Endometrial Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT06399757 -
A Study to Investigate APL-5125 in Adults With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT00095979 -
Ixabepilone in Treating Patients With Recurrent or Persistent Endometrial Cancer
|
Phase 2 | |
| Completed |
NCT00072176 -
Temsirolimus in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03460483 -
Universal Endometrial Cancer DNA Sequencing for Detection of Lynch Syndrome and Personalized Care
|
N/A |