A Phase I, First-in-Human, Dose Escalation Trial of MSC2363318A, a Dual p70S6K/Akt Inhibitor, in Subjects With Advanced Malignancies Save

Date Added
March 14th, 2017
PRO Number
Pro00060912
Researcher
Sara Giordano

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Keywords
Cancer, Men's Health, Women's Health
Summary

MSC2363318A is an investigational drug that is being evaluated for the treatment of subjects with advanced malignancies. Investigational means that it has not been approved by the Food and Drug Administration (FDA), and is still being tested for safety and effectiveness. This study will be divided into 2 parts. MUSC will participate in Part 2. The investigational drug will be given as a monotherapy, in combination with Tamoxifen (an FDA approved drug) and will be given in combination with Trastuzumab (also an FDA approved drug). The study is sponsored by EMD Serono. The investigator in charge of this study is Dr. Sara Giordano. The study is being done at 12 sites nationally. Approximately 64 people will take part, and 5 will take part at MUSC. In order to be eligible, subjects must be older than 18, have advanced maliginancies and specific genetic mutations.
The duration of the study will depend on how the subjects cancer responds to the medication and how it is tolerated.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
8438137372
hcc-clinical-trials@musc.edu

A Phase I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus + Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor Save

Date Added
September 13th, 2016
PRO Number
Pro00058989
Researcher
Sara Giordano

Silhouette
Keywords
Cancer, Cancer/Breast, Drug Studies, Men's Health, Women's Health
Summary

The purpose of this study is to find out if the drug ribociclib (LEE011), when taken with standard treatment, everolimus (Afinitor®) and exemestane (Aromasin®), is safe and beneficial in men and postmenopausal women who have advanced breast cancer that has recently become resistant to anti-estrogen therapy (meaning that your tumor progressed while on or being recently treated with anti-estrogen treatment). Participants in this study will remain on this study until his/her disease gets worse, or he/she no longer wish to participate.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB) Save

Date Added
May 24th, 2016
PRO Number
Pro00054909
Researcher
Sara Giordano

Silhouette
Keywords
Cancer, Cancer/Breast, Drug Studies, Women's Health
Summary

The purpose of this study is to test study treatments that combine an investigational drug (ONT-380) with two approved drugs (capecitabine and trastuzumab) in subjects with advanced breast cancer to find out what effects, good or bad, it may have on you and your disease.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

A Multistage, Phase II Study Evaluating the Safety and Efficacy of Cobimetinib Plus Paclitaxel, Cobimetinib plus Atezolizumab plus Paclitaxel, or Cobimetinib plus Atezolizumab plus NAB-Paclitaxel as First-Line Treatment for Patients with Metastatic Triple-Negative Breast Cancer Save

Date Added
April 14th, 2015
PRO Number
Pro00041847
Researcher
Sara Giordano

Silhouette
Keywords
Cancer, Cancer/Breast
Summary

This study is for patients who have been diagnosed with metastatic triple-negative breast cancer. The investigational drugs in this study are cobimentinib in combination with paclitaxel. The purpose of this study is to estimate the clinical benefit of cobimetinib and paclitaxel relative to placebo and paclitaxel, as
measured by investigator-assessed progression-free survival (PFS). The study will be conducted in two stages. The first stage is a safety run-in stage, which is designed as an early test of the combination of cobimetinib and paclitaxel. In this stage the combination will be given to approximately 12 subjects to evaluate any side effects of the combination. The second stage is the expansion stage where approximately 100 subjects will be given either cobimetinib paclitaxel or placebo paclitaxel (placebo is an inactive substance that looks like cobimetinib). Participants can expect to be in this study for approximately 12 months.

Institution
MUSC
Recruitment Contact
Jean Dangerfield
843-792-9321
dangerfj@musc.edu

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of EVEROLIMUS in Patients with High-Risk, Hormone Receptor-Positive AND HER2/neu Negative Breast Cancer Save

Date Added
January 16th, 2013
PRO Number
Pro00022260
Researcher
Sara Giordano

Silhouette
Keywords
Cancer, Cancer/Breast
Summary

This study is for women or men with hormone responsive breast cancer that has already been removed by surgery and have completed any required chemotherapy or radiation. The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for breast cancer patients. In this study subjects will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.
It is expected that subjects will be enrolled in this study for approximately 54 weeks or until side effects become too great, or until cancer returns. After subjects are finished with study treatment, they will return to the clinic every six months for the first 2 years and then yearly for the next 10 years.

Institution
MUSC
Recruitment Contact
Marietta Gustilo
843-792-2584
gustilom@musc.edu

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