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Protein Kinase Inhibitor
MK2206 + Hydroxychloroquine for Advanced Cancers
Phase 1
Waitlist Available
Led By Jyoti Malhotra
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 1
Patients must be able to swallow whole tablets; nasogastric or gastrostomy (G) tube administration is not allowed; tablets must not be crushed or chewed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights
Study Summary
This trial is testing the side effects and best dose of Akt inhibitor MK2206 with hydroxychloroquine in treating patients with advanced solid tumors, melanoma, prostate or kidney cancer.
Who is the study for?
This trial is for adults with advanced solid tumors, melanoma, prostate or kidney cancer who have tried at least one standard treatment. They must be able to swallow tablets, not be pregnant or breastfeeding, and agree to use contraception. People with certain eye diseases, uncontrolled diabetes, active infections or heart problems can't join.Check my eligibility
What is being tested?
The trial tests the combination of Akt Inhibitor MK2206 and Hydroxychloroquine on tumor growth. MK2206 blocks enzymes needed for cell growth while Hydroxychloroquine aims to kill or stop tumor cells from dividing and spreading.See study design
What are the potential side effects?
Possible side effects include issues related to liver function changes, digestive disturbances like nausea or diarrhea, vision problems due to hydroxychloroquine's potential effect on the retina, fatigue and an increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active and can carry on all pre-disease activities without restriction.
Select...
I can swallow tablets whole without needing to crush or chew them.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicity rate
Maximum tolerated dose of Akt inhibitor MK-2206
Secondary outcome measures
Change in autophagy activity induced by hydroxychloroquine
Changes in expression pattern of markers Beclin1, LC3, and p62
Validation of Beclin1, LC3, and p62 as markers for autophagy
Side effects data
From 2015 Phase 2 trial • 37 Patients • NCT0130763130%
fatigue
19%
Rash
16%
peripheral sensory neuropathy
16%
diarrhea
14%
constipation
14%
nausea
14%
edema limbs
11%
Thromboembolic event
11%
abdominal pain
11%
hyperglycemia
8%
anorexia
8%
vomiting
8%
hypomagnesemia
8%
back pain
5%
bone pain
5%
urinary tract infections
5%
pelvic pain
5%
anemia
5%
Acute kdiney injury
5%
Hyperglycemia
3%
urinary frequency
3%
hematuria
3%
creatinine decreased
3%
creatinine increased
3%
pleuritic pain
3%
cough
3%
bruising
3%
nail discoloration
3%
weight loss
3%
hot flashes
3%
hyponatremia
3%
skin ulceration
3%
vaginal hemorrhage
3%
anxiety
3%
insomnia
3%
arthralgia
3%
Fever
3%
non-cardiac chest pain
3%
ataxia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Akt Inhibitor MK2206
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (Akt inhibitor MK2206, hydroxychloroquine)Experimental Treatment2 Interventions
Patients receive Akt inhibitor MK2206 PO on days 1, 8, and 15. Beginning on cycle 2, patients also receive hydroxychloroquine PO BID on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Akt Inhibitor MK2206
2011
Completed Phase 2
~560
Hydroxychloroquine
2017
Completed Phase 4
~5360
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,717 Previous Clinical Trials
40,953,252 Total Patients Enrolled
Jyoti MalhotraPrincipal InvestigatorRutgers Cancer Institute of New Jersey
5 Previous Clinical Trials
184 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active and can carry on all pre-disease activities without restriction.I can swallow and retain medication without issues.I am not pregnant or nursing.I am HIV-positive and not on antiretroviral therapy.I have a liver condition like cirrhosis or chronic hepatitis.My heart's electrical cycle is normal and I'm not on QT-prolonging drugs.I do not have any severe illnesses or social situations that would interfere with the study.I do not have active brain metastases and have not needed steroids for them in over 2 months.My diabetes is not under control, with high blood sugar or HbA1c levels.I do not have psoriasis or porphyria.I have recovered from any side effects of my previous cancer treatments.My kidney function is within the required range for the trial.I have advanced cancer and have tried at least one standard treatment or have no standard treatments available.Your platelet count is at least 100,000 per microliter within the last 7 days before starting treatment.Patients must have a way to measure or evaluate their disease according to specific criteria.I agree to use birth control during and 6 months after the study.An eye doctor has approved me for hydroxychloroquine after a screening.I can swallow tablets whole without needing to crush or chew them.I do not have a G-6PD deficiency.I am currently being treated for rheumatoid arthritis or lupus.I am diabetic and use insulin to control my blood sugar.Your bilirubin levels are normal according to the lab's standards.I am not currently on any experimental treatments besides this study.I am not taking hydroxychloroquine for malaria.I am not pregnant, am post-menopausal, or have been surgically sterilized.You cannot be allergic to a specific type of medication called 4-aminoquinoline compound.You have had allergic reactions to drugs that are similar to the ones used in this study.Your white blood cell count needs to be above a certain number.Your white blood cell count is at least 3,000 cells per microliter.I haven't fully recovered from side effects of treatments or surgeries done over 4 weeks ago.You are expected to live for at least 12 more weeks.I have no eye damage from previous 4-aminoquinoline use.I do not have serious heart rhythm problems.I am willing to change medications that affect how a liver enzyme works if needed.Your liver enzymes (AST and ALT) are not more than 2.5 times the normal level.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (Akt inhibitor MK2206, hydroxychloroquine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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