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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

Must not have

Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, ulcerative colitis, inflammatory bowel disease, a partial or complete small bowel obstruction, or active peptic ulcer disease) that impairs their ability to swallow and retain MK-2206 or hydroxychloroquine tablets

Pregnant and nursing women are excluded from this study because developmental and reproductive toxicity studies of MK-2206 have not been performed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 21 days

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am fully active and can carry on all pre-disease activities without restriction.

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I can swallow tablets whole without needing to crush or chew them.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can swallow and retain medication without issues.

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I am not pregnant or nursing.

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I am HIV-positive and not on antiretroviral therapy.

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I have a liver condition like cirrhosis or chronic hepatitis.

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My heart's electrical cycle is normal and I'm not on QT-prolonging drugs.

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I do not have any severe illnesses or social situations that would interfere with the study.

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My diabetes is not under control, with high blood sugar or HbA1c levels.

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I do not have psoriasis or porphyria.

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I do not have a G-6PD deficiency.

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I am currently being treated for rheumatoid arthritis or lupus.

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I am diabetic and use insulin to control my blood sugar.

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I am not currently on any experimental treatments besides this study.

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I am not taking hydroxychloroquine for malaria.

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I have no eye damage from previous 4-aminoquinoline use.

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I do not have serious heart rhythm problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 21 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~21 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-limiting toxicity rate

Maximum tolerated dose of Akt inhibitor MK-2206

Secondary study objectives

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 • NCT01307631

30%

fatigue

19%

Rash

16%

peripheral sensory neuropathy

16%

diarrhea

14%

constipation

14%

nausea

14%

edema limbs

11%

Thromboembolic event

11%

abdominal pain

11%

hyperglycemia

anorexia

vomiting

hypomagnesemia

back pain

bone pain

urinary tract infections

pelvic pain

anemia

Acute kdiney injury

Hyperglycemia

pleuritic pain

creatinine decreased

cough

urinary frequency

creatinine increased

hematuria

bruising

nail discoloration

weight loss

hot flashes

hyponatremia

skin ulceration

vaginal hemorrhage

anxiety

insomnia

arthralgia

Fever

non-cardiac chest pain

ataxia

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Akt Inhibitor MK2206

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~4070