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Metastatic Breast CancerPhase 2NCT01240941

Trial of MK-2206 + Endocrine Treatment in Patients With Hormone Receptor Positive Breast Cancer

A Phase 2 study testing MK-2206, Exemestane and Goserelin in people with Metastatic Breast Cancer, run by Vanderbilt-Ingram Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a phase II Trial of MK-2206 in combination with Endocrine Therapy in patients with Hormone Receptor Breast Cancer. After the maximum tolerated dose is determined in the phase 1b trial (under a separate NCT number), efficacy will be evaluated among 17 patients. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
MK-2206, Exemestane and Goserelin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Feb 2011to Dec 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Patient who has had chemotherapy, radiotherapy, or biological therapy within 3 weeks (6 weeks for nitrosoureas, mitomycin C or bevacizumab), 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 less than or equal to 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 active CNS metastases and/or carcinomatous meningitis. However, patients with CNS metastases who have completed a course of therapy would be eligible for the study provided they are clinically stable for at least 1 month prior to entry as defined as: (1) no evidence of new or enlarging CNS metastasis (2)off steroids that are used to minimize surrounding brain edema.
  • Patient has a primary central nervous system tumor.
  • Patient has known hypersensitivity to the components of study drug or its analogs.
Show all 22Show fewer
  • Patient has a history or current evidence of clinically significant heart disease including:
  • 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 Investigator.
  • Baseline QTc prolongation greater than 450 msec (Bazett's Formula). Medications included in Arizona CERT Lists 1 and 2 (Appendix D) must be excluded. The concomitant use of drugs that are associated with increased risk for QT prolongation should be avoided in patients with congenital long QT syndrome (Appendix D, Arizona CERT List 3). Similarly, the concomitant use of drugs that are weakly associated with QT prolongation should be generally avoided (Appendix D, Arizona CERT List 4). Arizona CERT List 3 and 4 drugs should be used at the discretion of the Investigator and restricted where applicable. Any therapy given with these drugs should be used with caution, and patients receiving these medications should be carefully monitored.
  • Patient with evidence of clinically significant bradycardia (heart rate less than 50 ), or a history of clinically significant bradyarrhythmias such as sick sinus syndrome, 2nd degree AV block (Mobitz Type 2), or patients taking beta blockers, non-dihydropyridine calcium channel blockers, or digoxin.
  • 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 defined as HbA1C greater than 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 pregnant or 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).

About this study

Official title: Phase II Trial of MK-2206 (an AKT Inhibitor) in Combination With Endocrine Therapy in Patients With Hormone Receptor Positive Breast Cancer

This is a phase II Trial of MK-2206 in combination with Endocrine Therapy in patients with Hormone Receptor Breast Cancer. After the maximum tolerated dose is determined in the phase 1b trial (under a separate NCT number), efficacy will be evaluated among 17 patients.

Being tested
MK-2206, Exemestane, Goserelin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-2206Drug

    dose to be determined on the Phase 1b trial (listed under a separate NCT number)

  • ExemestaneDrug

    25 mg orally daily

  • GoserelinDrug

    3.6 mg orally monthly

Study groups in NCT01240941
Study groupRoleWhat they receive
MK-2206ExperimentalMK-2206 maximum tolerated dose found from Phase Ib trial (under a separate NCT number) taken orally on a weekly basis
Receives: Drug: MK-2206; Drug: Exemestane; Drug: Goserelin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy endpoint: Antitumor activity of MK-2206 when combined with exemestane +/- goserelin in pre- and post-menopausal patients with hormone receptor positive metastatic breast cancer, measured by clinical benefit rate.

    Clinical benefit rate is defined as complete response + partial response + stable disease for at least 24 weeks following initiation of treatment.

    Measured: 24 weeks (6 cycles)

Secondary outcomes (2)

  1. The safety and tolerability of MK-2206 given in combination with exemestane +/- goserelin in pre- and post-menopausal patients with hormone receptor positive metastatic breast cancer.

    Measured: every four weeks (1 cycle)

  2. Characterize the effect of MK-2206 in combination with exemestane +/- goserelin based on PI3K, AKT, and PTEN mutations

    Measured: tumor blocks to be obtained prior to beginning the trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionJun 2012 (estimated)
  4. Study completionDec 2012 (estimated)

Why it stopped: Funding was not available

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01240941
Sponsor's protocol ID
VICC BRE1029
Status last verified
Aug 2013
First submitted
26 Oct 2010
Last updated
20 Aug 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK-2206, Exemestane and Goserelin in people with Metastatic Breast Cancer, run by Vanderbilt-Ingram Cancer Center.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy endpoint: Antitumor activity of MK-2206 when combined with exemestane +/- goserelin in pre- and post-menopausal patients with hormone receptor positive metastatic breast cancer, measured by clinical benefit rate. (time frame: 24 weeks (6 cycles)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01240941.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2013.

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