Phase 2 N=9 Treatment

Dual mTOR Inhibitor MLN0128 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients

Metastatic Castration-Resistant Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02091531 ↗

Enrolled (actual)

Serious AEs

66.7%

Results posted

Oct 2019

Primary outcome: Primary: Median Time on Treatment — 11 weeks

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: MLN0128 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Time on Treatment	11	—
SECONDARY Median PSA Rise at End of Treatment as Compared to Baseline	159	—
SECONDARY Best Response	8; 1	—

Summary

This is a phase II study which will test the study drug MLN0128 in patients with castration resistant prostate cancer who have received chemotherapy in the past. Phase II clinical trials test how well an investigational drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it. MLN0128 is not approved by the FDA. The purpose of this study is to see what effects (good and bad) the study drug MLN0128 has on the patient and the cancer. MLN0128 is a drug that belongs to a class of drugs called "mTOR kinase inhibitors". A protein, called "mTOR" inside the cells in the body, plays a role in controlling how cells grow. In some cancer cells, mTOR may be over-active. This over-activity may cause some cancer cells to grow out of control. Research has shown that mTOR inhibitors can block this overactivity and may help stop or slow down the growth of some types of cancer cells.

Eligibility Criteria

To be included in this study, patients should have histologically confirmed castration resistant metastatic prostate cancer with evidence of disease progression. Patients must have been in a castrate state either by orchiectomy or by GnRH analogues. In detail, they should meet all of the following criteria

Inclusion Criteria

Histologically confirmed prostate cancer with progressive metastatic disease based on any of the following: i) a rise in PSA, ii) transaxial imaging, or iii) radionuclide bone scan.
PSA - a minimum of 3 consecutive rising levels, with an interval of ≥

1 week between each determination. The last determination must have a minimal value of ≥ 2 ng/mL and be determined within two weeks prior to enrollment.

Measurable Disease - patients showing new or progressive soft tissue masses on CT or MRI scans as defined by the PCWG2 criteria21
Radionuclide bone scan - at least two new metastatic lesions.
Detectable metastases by bone scan, CT-scan or MRI.
Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone (GnRH) analogue or inhibitor, or orchiectomy (i.e., surgical or medical castration).

For patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trial.

Castrate levels of serum testosterone 180 mmHg, diastolic blood pressure > 95 mmHg) b. Grade 3 or higher valvular disease c. Grade 3 or higher atrial fibrillation d. Grade 3 or higher bradycardia e. Endocarditis f. Pulmonary embolism g. Recent cerebrovascular accident within 6 months prior to enrollment
A requirement for positive inotropic support (excluding digoxin) or serious uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation) within 1 year prior to screening
A pacemaker or implantable cardiac defibrillator
Known history of infection with human immunodeficiency virus (HIV), based on medical history (screening labs to rule out HIV infection are not required);
Any other condition that, in the opinion of the Investigator, would impair the patient's ability to comply with study procedures.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02091531). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.