NCT00881946

A Phase I, Open-Label, Two-Stage Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Oral AKT Inhibitor GSK2110183 in Subjects With Any Hematologic Malignancy

Completed Phase 1/Phase 2 Last updated 3 April 2012

What this trial tests

Phase 1/Phase 2 trial testing GSK21110183 in Hematologic Malignancies in 73 participants. Completed in 1 March 2012.

Timeline

1 July 2009

Primary endpoint
1 March 2012

1 March 2012

Quick facts

Lead sponsor	Accenture
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	73
Start date	1 July 2009
Primary completion	1 March 2012
Estimated completion	1 March 2012
Sites	4 locations across Australia, Canada, South Korea

Drugs / interventions tested

• GSK21110183 — full drug profile →

Conditions studied

• Hematologic Malignancies — all drugs for Hematologic Malignancies →

Sponsor

Accenture — full company profile →

Who can join

18 and older, any sex, with Hematologic Malignancies. 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.

• Physical exam
  Time frame: Screening, Days -3, 8, At the start of each additional Cycle
• Electrocardiogram (ECG)
  Time frame: Days -3, -2, -1, 8, 15, At the start of each additional Cycle
• Vital signs
  Time frame: Screening, Days -3, -2, -1, 8, 15, At the start of each additional Cycle
• Transthoracic Echocardiogram (TTE)/Multiple Gated Acquisition (MUGA) Scans
  Time frame: Screening, Additionally as needed
• Clinical Laboratory assessments
  Time frame: Screening, Days -3, 1, 8, 15, At the start of each additional Cycle
• ECOG Peformance Status
  Time frame: Screening, Days -3, 8, At the start of each additional Cycle

Sponsor's own description

The purpose of this study is to characterize the safety and tolerability of repeat doses of compound GSK2110183 in subjects with hematologic cancer.

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. The Akt pathway in oncology therapy and beyond (Review).
   Nitulescu GM, Van De Venter M, Nitulescu G, Ungurianu A, et al · · 2018 · cited 273× · PMID 30334567 · DOI 10.3892/ijo.2018.4597
3. 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
4. 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
5. The novel AKT inhibitor afuresertib shows favorable safety, pharmacokinetics, and clinical activity in multiple myeloma.
   Spencer A, Yoon SS, Harrison SJ, Morris SR, et al · · 2014 · cited 102× · PMID 25075128 · DOI 10.1182/blood-2014-03-559963
6. Targeting PI3K/Akt/mTOR in AML: Rationale and Clinical Evidence.
   Darici S, Alkhaldi H, Horne G, Jørgensen HG, et al · · 2020 · cited 87× · PMID 32932888 · DOI 10.3390/jcm9092934
7. Targeting the PI3K/mTOR Pathway in Pediatric Hematologic Malignancies.
   Tasian SK, Teachey DT, Rheingold SR. · · 2014 · cited 86× · PMID 24904824 · DOI 10.3389/fonc.2014.00108
8. Targeting mTOR signaling pathways and related negative feedback loops for the treatment of acute myeloid leukemia.
   Carneiro BA, Kaplan JB, Altman JK, Giles FJ, et al · · 2015 · cited 33× · PMID 25801978 · DOI 10.1080/15384047.2015.1026510