A Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

Date Added
May 10th, 2022
PRO Number
Pro00119953
Researcher
Theodore Gourdin

List of Studies


Keywords
Bladder, Cancer, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Prostate, Women's Health
Summary

This study is for patients that have already received standard treatments for their cancer and their cancer has gotten worse or returned after their last treatment. The purpose of this study is to learn about the effects of the study drug XL092 when given alone, in combination with atezolizumab, and in combination with avelumab by testing its safety, the ability of your body to accept the drug(s), to measure the drug(s) and/or its break-down products levels in your blood, and how your body reacts to the drug(s). This research study will be the first time XL092 alone or in combination with atezolizumab will be given to people. The study drugs in this research have not been approved by the United States Food and Drug Administration (FDA). There are two parts in this study, a Dose Escalation part and a Cohort Expansion part. The first part of the study was the Dose Escalation phase, when different participants were given different doses of the study drug until the safest, most effective dose was found; this part of the study has been completed. The study is now enrolling to the Cohort Expansion part of this study, where the dose that has been determined to be safe will be given to more participants with different types of cancer. The Dose Escalation part of this study has stopped and the safe dose has been found. This study is now enrolling to the Cohort Expansion part of this study, where the safe dose of the study drug found in the Dose Escalation part will be given to more participants with different types of cancer. Participants will either be assigned to the treatment group that will receive XL092 alone or the treatment group that XL092 in combination with atezolizumab. Which treatment group they are assigned depends on the type of cancer they have. TXL092 is in tablet form taken by mouth. Avelumab will be given as an intravenous (IV) infusion once every 2 weeks at the study site. Atezolizumab will be given as an intravenous (IV) infusion once every 3 weeks at the study site. Total study duration is expected to be about 6 months but participants could be in the study for up to 2 years.

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

A PHASE III CLINICAL TRIAL EVALUATING DEESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I, HORMONE SENSITIVE, HER2-NEGATIVE, ONCOTYPE RECURRENCE SCORE ≤ 18 BREAST CANCER

Date Added
August 29th, 2021
PRO Number
Pro00113932
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Breast
Summary

This study is for men and women with breast cancer. The purpose of this study is to compare the usual treatment of breast radiation and hormonal drugs after lumpectomy to using hormonal drugs alone.

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

Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Date Added
January 19th, 2021
PRO Number
Pro00106552
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer/Breast
Summary

This study is for patients who have low risk breast cancer as indicated by their Oncotype DX Recurrence Score. The purpose of this study is to compare any good and bad effects of not giving regional radiotherapy to using regional radiotherapy.

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

FDG PET to Assess Therapeutic Response in Patients With Bone-Dominant Metastatic Breast Cancer, FEATURE

Date Added
December 22nd, 2020
PRO Number
Pro00106499
Researcher
Frank Brescia

List of Studies


Keywords
Cancer/Breast
Summary

This study is for patients with metastatic breast cancerDoctors are doing this study because they want to find out if FDG-PET/CT imaging is better or worse than the usual approach for monitoring metastatic breast cancer, which is in the bone or mostly in the bone.

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

Tomosynthesis Mammographic Imaging Screening Trial (TMIST)

Date Added
December 21st, 2017
PRO Number
Pro00073365
Researcher
Sarah Marrison

List of Studies


Keywords
Cancer/Breast
Summary

This study is for women being screened for breast cancer. The main purpose of this study is to determine whether screening for breast cancer with tomosynthesis mammography is superior to digital mammography for breast cancer screening.

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

Date Added
January 16th, 2013
PRO Number
Pro00022260
Researcher
Frank Brescia

List of Studies


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

A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

Date Added
August 7th, 2012
PRO Number
Pro00017993
Researcher
Frank Brescia

List of Studies


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

This study is being done for the following reasons:
•This study is being done to find out if a combination of just two chemotherapy drugs, docetaxel and cyclophosphamide, is as good as using different combinations of the chemotherapy drugs doxorubicin and cyclophosphamide, given with either docetaxel or paclitaxel, in treating your type of breast cancer. All of these drugs are used in standard combinations of chemotherapy for breast cancer.
•The researchers also want to learn about the side effects of the combinations of drugs used in this study. Side effect information will also be studied to see if there are any differences between the two-drug and three-drug chemotherapy combinations.
•In order to learn more about cancer tumors, this study includes special research tests that will be done on tumor tissue that was removed during your breast cancer surgery. Information about this study requirement will be explained to you in more detail later in this consent form.

Institution
MUSC
Recruitment Contact
Katherine Halloran
843-792-7035
halloran@musc.edu

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer

Date Added
January 10th, 2012
PRO Number
Pro00015069
Researcher
Megan Ruppel

List of Studies

Keywords
Cancer, Cancer/Breast
Summary

The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation for the tumor in your breast to the standard approach of continued treatment with the medication which is working to control your tumor.

Institution
MUSC
Recruitment Contact
Katherine Halloran
843-792-7035
halloran@musc.edu



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