Phase 2
Completed N=21
Akt Inhibitor MK2206 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Source: ClinicalTrials.gov NCT01349933 ↗Enrolled (actual)
21
Serious AEs
47.6%
Results posted
Jan 2015
Primary outcomePrimary: Proportion of Patients Alive and Progression-free — 9; 12 participants
Summary
This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with recurrent or metastatic head and neck cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Alive and Progression-free |
9; 12 | — |
| PRIMARY Confirmed Response Rate Defined to be a CR or PR Noted as the Objective Status on 2 Consecutive Evaluations at Least 4 Weeks Apart |
0; 4.8 | — |
| SECONDARY Adverse Events Associated With the Agent Graded Based on CTCAE Version 4.0 |
13; 0 | — |
| SECONDARY Overall Survival |
10.0 | — |
| SECONDARY Progression-free Survival |
3.5 | — |
| SECONDARY Best Response (Complete Response vs Partial Response vs Stable Disease vs Progression) |
11; 1; 0; 9 | — |
| SECONDARY Duration of Response |
— | — |
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically confirmed non-keratinizing nasopharyngeal carcinoma that has recurred at locoregional and/or distant sites, and is not amenable to potentially curative radiotherapy or surgery
- Measurable disease according to the RECIST criteria
- Progressed = = 9 g/dL
- ANC >= 1,500/μL
- Platelet count >= 100,000/μL
- Total bilirubin = = 60 mL/min/1.73 m^2
- Ability to understand and the willingness to sign a written informed consent document
- Willingness to donate blood for mandatory correlative research studies
- Negative (serum) pregnancy test done = 150 mg/dL (HbA1c 8.3 mmol/L), or a random glucose level of >180mg/dL (> 10 mmol/L) is considered to have inadequately controlled diabetes and are not eligible for this study; however, such patients can become eligible in the future if their fasting glucose levels improve with medical treatment
- QTc prolongation (defined as a QTc interval > 450 msec for males and >470 msec for females) or other significant ECG abnormalities; NOTE: patients with clinically significant cardiac conduction abnormalities should be excluded, these include left bundle branch block (LBBB), 2nd or 3rd degree AV block, bifascicular block, sick sinus syndrome, Wolff-Parkinson-white syndrome, sinus bradycardia ( = grade 2 adverse events (excluding alopecia) due to agents (chemotherapy or radiotherapy) administered > 4 weeks prior to registration based on Common Terminology Criteria for Adverse Events (CTCAE version 4.0) =< grade 1
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- NOTE: because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with MK-2206, breastfeeding should be discontinued if the mother is treated with MK-2206; women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
- HIV-positive patients on combination antiretroviral therapy; NOTE: HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with MK-2206; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy
- Recent major surgery =< 4 weeks prior to registration (excluding the placement of vascular access), or minor surgery =< 2 weeks prior to registration
- Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption) that impairs patients ability to swallow MK-2206 tablets
Data sourced from ClinicalTrials.gov (NCT01349933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.