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

NCT ID: NCT01240941

Last Updated: 2013-08-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-12-31

Brief 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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MK-2206

MK-2206 maximum tolerated dose found from Phase Ib trial (under a separate NCT number) taken orally on a weekly basis

Group Type: EXPERIMENTAL

MK-2206

Intervention Type: DRUG

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

Exemestane

Intervention Type: DRUG

25 mg orally daily

Goserelin

Intervention Type: DRUG

3.6 mg orally monthly

Interventions

MK-2206

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

Intervention Type: DRUG

Exemestane

25 mg orally daily

Intervention Type: DRUG

Goserelin

3.6 mg orally monthly

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

1. 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.

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

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

4. 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.

5. Patient has a primary central nervous system tumor.

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

7. 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.

8. 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.

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

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

11. Patient with poorly controlled diabetes defined as HbA1C greater than 8%.

12. 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.

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

14. 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.

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

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

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

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Vandana Abramson

Assistant Professor of Medicine, Medical Oncologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vandana Abramson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Countries

United States

Other Identifiers

VICC BRE1029

Identifier Type: -

Identifier Source: org_study_id