Who is sponsoring NCT01307631?

NCT01307631 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT01307631?

Interventions in NCT01307631: Akt Inhibitor MK2206, Laboratory Biomarker Analysis.

What condition does NCT01307631 study?

NCT01307631 studies Endometrial Adenocarcinoma, Endometrial Adenosquamous Carcinoma, Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma, Recurrent Uterine Corpus Carcinoma.

Is NCT01307631 still recruiting?

NCT01307631 is currently completed. Last updated 13 January 2022.

Are results published for NCT01307631?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-01-13 · How we verify

NCT01307631

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase II, 2-Stage, 2-Arm PIK3CA Mutation Stratified Trial of MK-2206 in Recurrent or Advanced Endometrial Cancer

Completed Phase 2 Results posted Last updated 13 January 2022

What this trial tests

Phase 2 trial testing Akt Inhibitor MK2206 in Endometrial Adenocarcinoma in 37 participants. Completed in 18 September 2015.

Timeline

1 March 2011

Primary endpoint
18 September 2015

18 September 2015

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	1 March 2011
Primary completion	18 September 2015
Estimated completion	18 September 2015
Sites	7 locations across United States

Drugs / interventions tested

Akt Inhibitor MK2206 — full drug profile →
Laboratory Biomarker Analysis — full drug profile →

Conditions studied

Endometrial Adenocarcinoma — all drugs for Endometrial Adenocarcinoma →
Endometrial Adenosquamous Carcinoma — all drugs for Endometrial Adenosquamous Carcinoma →
Endometrial Clear Cell Adenocarcinoma — all drugs for Endometrial Clear Cell Adenocarcinoma →
Endometrial Serous Adenocarcinoma — all drugs for Endometrial Serous Adenocarcinoma →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, female only, with Endometrial Adenocarcinoma or Endometrial Adenosquamous Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Objective Tumor Response According to RECIST
Time frame: Up to 6 months
Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in sho
Progression-free Survival According to RECIST
Time frame: From start of treatment to time of objective disease progression, assessed up to 6 months
Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions. Any pathological lymph node must have reduction in sho

Sponsor's own description

This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with recurrent or advanced endometrial cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Role of PI3K/AKT pathway in cancer: the framework of malignant behavior.
Jiang N, Dai Q, Su X, Fu J, et al · · 2020 · cited 419× · PMID 32333246 · DOI 10.1007/s11033-020-05435-1
Maximising the potential of AKT inhibitors as anti-cancer treatments.
Brown JS, Banerji U. · · 2017 · cited 184× · PMID 27919797 · DOI 10.1016/j.pharmthera.2016.12.001
The Warburg effect: evolving interpretations of an established concept.
Chen X, Qian Y, Wu S. · · 2015 · cited 177× · PMID 25277420 · DOI 10.1016/j.freeradbiomed.2014.08.027
Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6
Targeting the RAS oncogene.
Takashima A, Faller DV. · · 2013 · cited 95× · PMID 23360111 · DOI 10.1517/14728222.2013.764990
Characterization of cancer genomic heterogeneity by next-generation sequencing advances precision medicine in cancer treatment.
Zhang J, Späth SS, Marjani SL, Zhang W, et al · · 2018 · cited 90× · PMID 30687561 · DOI 10.1093/pcmedi/pby007
The genomics and genetics of endometrial cancer.
O'Hara AJ, Bell DW. · · 2012 · cited 86× · PMID 22888282 · DOI 10.2147/agg.s28953
Everolimus as second- or third-line treatment of advanced endometrial cancer: ENDORAD, a phase II trial of GINECO.
Ray-Coquard I, Favier L, Weber B, Roemer-Becuwe C, et al · · 2013 · cited 66× · PMID 23612453 · DOI 10.1038/bjc.2013.183

Verify or expand the search:

Other trials of Akt Inhibitor MK2206

Trials testing the same drug.

NCT01783171 — Dinaciclib and Akt Inhibitor MK2206 in Treating Patients With Pancreatic Cancer That Cannot Be Removed by Surgery · Phase 1 · completed
NCT01604772 — Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma · Phase 2 · completed
NCT01480154 — Akt Inhibitor MK2206 and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors, Melanoma, Prostate or Kidne · Phase 1 · active not recruiting
NCT01344031 — MK2206 in Combination With Anastrozole, Fulvestrant, or Anastrozole and Fulvestrant in Treating Postmenopausal Women Wit · Phase 1 · completed
NCT01239342 — Akt Inhibitor MK2206 or Everolimus in Treating Patients With Refractory Kidney Cancer · Phase 2 · terminated

Other recruiting trials for Endometrial Adenocarcinoma

Currently open trials in the same condition.

NCT07077876 — Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Tre · recruiting
NCT06917092 — QL1706-Based Therapy Post-PD-1/L1 Failure in Advanced Endometrial Cancer · Phase 2 · recruiting
NCT05824481 — Study of Cadonilimab (AK104) Plus Lenvatinib in Patients With Advanced Endometrial Cancer · Phase 2 · active not recruiting
NCT05548296 — A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma · Phase 2 · recruiting
NCT05112601 — Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma · Phase 2 · recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01307631 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 13 January 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01307631.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing