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A Phase II Clinical And Translational Study Of MK-2206 In Patients With Metastatic KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer

Phase 2
18 Years
Not Enrolling
Colon Cancer, Rectal Cancer

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Trial Information

A Phase II Clinical And Translational Study Of MK-2206 In Patients With Metastatic KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer

Inclusion Criteria:

- Patient must have metastatic colorectal cancer that has been histologically or
cytologically-confirmed at MSKCC and has failed to respond to appropriate standard
therapy regimens. There is no limit on the number of prior treatment regimens

- Patient is male or female and ≥18 years of age on the day of signing informed

- Patient must have performance status of 0 or 1 on the ECOG Performance Scale.

- Patient must have adequate organ function as indicated by the following laboratory

- Absolute neutrophil count (ANC) ≥1,500 /μL

- Platelets ≥100,000 /μL

- Hemoglobin ≥9 g/dL

- Serum creatinine or calculated creatinine clearance ≤1.5 x upper limit of normal
(ULN) OR ≥60 mL/min for patients with creatinine levels >1.5 x institutional ULN

- Serum total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ ULN for patients with total
bilirubin levels >1.5 x ULN

- AST (SGOT) and ALT (SGPT) ≤3 x ULN or ≤5 x ULN in patients with known liver

- Prothrombin time (PT)/INR ≤1.5 x ULN

- Partial thromboplastin time (PTT)≤1.5 x ULN

- Fasting serum glucose ≤120 mg/dl

- HBA1C ≤8%

- Potassium in normal range

- The patient has a tumor that has wild type KRAS (absence of mutations at codons 12 or
13), and mutant PIK3CA (presence of mutations in exons 20 or 9).

- Female patient of childbearing potential who are not surgically sterilized must have
a negative serum or urine pregnancy test β-hCG within 72 hours prior to receiving the
first dose of study medication.

- Patient, or the patient's legal representative, has voluntarily agreed to participate
by giving written informed consent.

- Patient is able to swallow capsules and has no surgical or anatomical condition that
will preclude the patient from swallowing and absorbing oral medications on an
ongoing basis.

Exclusion Criteria:

- Patient who has had chemotherapy, radiotherapy, or biological therapy within 3 weeks
(6 weeks for nitrosoureas or mitomycin C), or who has not recovered from the adverse
events due to previous agents administered more than 4 weeks prior to Study Day 1. If
the patient has residual toxicity from prior treatment, toxicity must be ≤ Grade 1.

- Patients must be at least 4 weeks post major surgical procedure, and all surgical
wounds must be fully healed.

- Patient is currently participating or has participated in a study with an
investigational compound or device within 30 days of Study Day 1.

- Patient has known CNS metastases and/or carcinomatous meningitis.

- Patient has a primary central nervous system tumor.

- Patient has known hypersensitivity to the components of study drug or its analogs.

- Patient has a history or current evidence of clinically significant heart disease

- Clinically significant congestive heart failure, unstable angina pectoris,

- Clinically significant cardiac arrhythmia,

- History or current evidence of a myocardial infarction during the last 6 months,
and/or a current ECG tracing that is abnormal in the opinion of the treating

- QTc prolongation ≥450 msec (Bazett's Formula), Patient with evidence of clinically
significant bradycardia (HR <50), or a history of clinically significant
bradyarrhythmias such as sick sinus syndrome, 2nd degree AV block (Mobitz Type 2).

- Patient with uncontrolled hypertension (i.e., > 160/90 mHg SiBP). Patients who are
controlled on antihypertensive medication will be allowed to enter the study.

- Patient at significant risk for hypokalemia (e.g., patients on high dose diuretics,
or with recurrent diarrhea)

- Patient with poorly controlled diabetes (HBA1C >8%)

- Patient has a history or current evidence of any condition, therapy, or lab
abnormality that might confound the results of the study, interfere with the
patient's participation for the full duration of the study, or is not in the best
interest of the patient to participate, in the opinion of the treating Investigator.

- Patient has known psychiatric or substance abuse disorders that would interfere with
cooperation with the requirements of the trial

- Patient is, at the time of signing informed consent, a regular user (including
―recreational use‖) of any illicit drugs or had a recent history (within the last
year) of drug or alcohol abuse.

- Patient is breastfeeding or expecting to conceive or father children within the
projected duration of the study.

- Patient is known to be Human Immunodeficiency Virus (HIV)-positive

- Patient has known history of Hepatitis B or C or active Hepatitis A.

- Patient has symptomatic ascites or pleural effusion. A patient who is clinically
stable following treatment for these conditions is eligible.

- Patient is receiving treatment with oral corticosteroids (note: inhaled
corticosteroids are permitted).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the overall objective response rate (ORR)

Outcome Description:

in patients with metastatic colorectal cancer with known PIK3CA mutations and wild type KRAS, to single agent MK-2206.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Leonard Saltz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

August 2012

Related Keywords:

  • Colon Cancer
  • Rectal Cancer
  • MK-2206
  • colon
  • rectal
  • 10-068
  • Colonic Neoplasms
  • Rectal Neoplasms
  • Colorectal Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021