NCT01258998

Phase II Study of MK-2206 in Patients With Relapsed Lymphoma

Completed Phase 2 Results posted Last updated 14 October 2020

What this trial tests

Phase 2 trial testing Akt inhibitor MK2206 in Adult Nasal Type Extranodal NK/T-cell Lymphoma in 60 participants. Completed in 1 August 2015.

Timeline

1 December 2010

Primary endpoint
1 July 2014

1 August 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	60
Start date	1 December 2010
Primary completion	1 July 2014
Estimated completion	1 August 2015
Sites	1 location across United States

Drugs / interventions tested

• Akt inhibitor MK2206 — full drug profile →
• laboratory biomarker analysis — full drug profile →

Conditions studied

• Adult Nasal Type Extranodal NK/T-cell Lymphoma — all drugs for Adult Nasal Type Extranodal NK/T-cell Lymphoma →
• Anaplastic Large Cell Lymphoma — all drugs for Anaplastic Large Cell Lymphoma →
• Angioimmunoblastic T-cell Lymphoma — all drugs for Angioimmunoblastic T-cell Lymphoma →
• B-cell Adult Acute Lymphoblastic Leukemia — all drugs for B-cell Adult Acute Lymphoblastic Leukemia →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Adult Nasal Type Extranodal NK/T-cell Lymphoma or Anaplastic Large Cell Lymphoma. 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 Response Rate (ORR)
  Time frame: 4 months
  Complete Response (CR) Disappearance of all evidence of disease(a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative (b) Variably FDG-avid or PET negative; regression to normal size on CT Not palpable, nodules disappeared Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immuno histochemistry should be negative. Partial Response (PR) Regressi

Sponsor's own description

This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating patients with relapsed lymphoma. 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. 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
2. 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
3. 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
4. Phase II study of an AKT inhibitor MK2206 in patients with relapsed or refractory lymphoma.
   Oki Y, Fanale M, Romaguera J, Fayad L, et al · · 2015 · cited 71× · PMID 26213141 · DOI 10.1111/bjh.13603
5. Signaling Pathway Mediating Myeloma Cell Growth and Survival.
   Hideshima T, Anderson KC. · · 2021 · cited 57× · PMID 33435632 · DOI 10.3390/cancers13020216
6. Therapeutic options in peripheral T cell lymphoma.
   Zhang Y, Xu W, Liu H, Li J. · · 2016 · cited 31× · PMID 27071634 · DOI 10.1186/s13045-016-0267-0
7. Altered pathways and targeted therapy in double hit lymphoma.
   Zhuang Y, Che J, Wu M, Guo Y, et al · · 2022 · cited 26× · PMID 35303910 · DOI 10.1186/s13045-022-01249-9
8. CounterAKTing HIV: Toward a "Block and Clear" Strategy?
   Pasquereau S, Herbein G. · · 2022 · cited 24× · PMID 35186800 · DOI 10.3389/fcimb.2022.827717