Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01011933
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date September 2009
Completion date January 2016

See also
  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