NCT01277757

Phase II Trial of AKT Inhibitor MK2206 in Patients With Advanced Breast Cancer Who Have Tumors With a PIK3CA Mutation, or an AKT Mutation, and/or PTEN Loss/PTEN Mutation

Completed Phase 2 Results posted Last updated 28 November 2018

What this trial tests

Phase 2 trial testing Akt Inhibitor MK2206 in Recurrent Breast Carcinoma in 30 participants. Completed in 1 August 2014.

Timeline

1 March 2011

Primary endpoint
1 August 2014

1 August 2014

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	30
Start date	1 March 2011
Primary completion	1 August 2014
Estimated completion	1 August 2014
Sites	5 locations across United States

Drugs / interventions tested

• Akt Inhibitor MK2206 — full drug profile →
• Laboratory Biomarker Analysis — full drug profile →
• Pharmacological Study — full drug profile →

Conditions studied

• Recurrent Breast Carcinoma — all drugs for Recurrent Breast Carcinoma →
• Stage IIIB Breast Cancer — all drugs for Stage IIIB Breast Cancer →
• Stage IIIC Breast Cancer — all drugs for Stage IIIC Breast Cancer →
• Stage IV Breast Cancer — all drugs for Stage IV Breast Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Recurrent Breast Carcinoma or Stage IIIB Breast Cancer. 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.

• Number of Participants With Response Defined Using Response Evaluation Criteria In Solid Tumors (RECIST)
  Time frame: Up to 3 weeks after completion of study treatment, for up to 1 year
  Number of participants with response defined by RECIST version 1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD
• Number of Participants With Objective Response
  Time frame: 4 weeks following beginning treatment, repeat confirmation 4-6 weeks following response, up to 1 year
  Only those participants who have measurable disease present at baseline, have received at least four doses of MK2206, and have had their disease re-evaluated will be considered evaluable for response. Response classified according the RECIST definitions, and re-evaluated for response every 12 weeks. (Note: Participants who exhibit objective disease progression prior to receiving four doses of ther

Sponsor's own description

This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with breast cancer cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. 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):

1. Small molecules in targeted cancer therapy: advances, challenges, and future perspectives.
   Zhong L, Li Y, Xiong L, Wang W, et al · · 2021 · cited 1003× · PMID 34054126 · DOI 10.1038/s41392-021-00572-w
2. The PI3K/AKT/mTOR pathway in breast cancer: targets, trials and biomarkers.
   Paplomata E, O'Regan R. · · 2014 · cited 425× · PMID 25057302 · DOI 10.1177/1758834014530023
3. 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
4. Deregulation of the EGFR/PI3K/PTEN/Akt/mTORC1 pathway in breast cancer: possibilities for therapeutic intervention.
   Davis NM, Sokolosky M, Stadelman K, Abrams SL, et al · · 2014 · cited 186× · PMID 25051360 · DOI 10.18632/oncotarget.2209
5. 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
6. 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
7. The genomic landscape of breast cancer as a therapeutic roadmap.
   Ellis MJ, Perou CM. · · 2013 · cited 167× · PMID 23319768 · DOI 10.1158/2159-8290.cd-12-0462
8. Phase II trial of AKT inhibitor MK-2206 in patients with advanced breast cancer who have tumors with PIK3CA or AKT mutations, and/or PTEN loss/PTEN mutation.
   Xing Y, Lin NU, Maurer MA, Chen H, et al · · 2019 · cited 165× · PMID 31277699 · DOI 10.1186/s13058-019-1154-8