Clinical Trials
A clinical trial is a research study that involves volunteers to test new drugs, treatments and diagnostic tools to help doctors better understand how to diagnose, treat and prevent diseases or conditions.
Clinical trials are vital in studying all aspects of medicine with the goal of helping patients live longer, healthier lives. In the United States, the Food and Drug Administration (FDA) requires all new drugs and other treatments to be tested in clinical trials before being approved. Clinical trials show us what works in medicine and healthcare.
Types of Clinical Trials
Cancer Treatment Trials
Tests new drugs or new combination of drugs. These trials also test new approaches to surgery or giving radiation therapy.
Cancer Prevention Trials
Focus on the use of different medications or change in diet and exercise to determine if the risk of developing cancer decreases or stop it from recurring.
Diagnostic Trials
They find new ways to understand a particular disease or condition.
Screening Trials
Test the best way to detect cancer earlier.
Quality of Life Trials
Cancer can affect people’s health for years, so doctors explore ways to better manage and improve comfort for people who are living with cancer through supportive care trials. Doctors are always looking for ways to make people with cancer feel better.
Participate in a Clinical Trial
The best way to find a clinical trial is to first speak with your doctor and ask about trials that may be appropriate for your cancer type and stage. We have a Research Team here at Millennium Physicians, offering clinical trials that are available to our patients with cancer. If your doctor recommended a clinical trial that you are eligible to participate in and have additional questions, please feel free to contact our research staff for further assistance. They are always happy to explain details of a particular study including the trial’s purpose, how long it will take, what to expect, all potential risks and benefits and information on the privacy of your medical records.
Every clinical trial has its own protocol that determines the eligibility criteria needed in order to participate in that study. Following eligibility criteria helps the doctor and clinical trial research team keep you safe, makes sure the trial treatment is right for you and ensures that researchers learn the information they need. No treatment or procedure, even one already in common use, is entirely without risk. But ask yourself, do the benefits of the new treatment outweigh the possible risks?
It is important to share information about your health with the research team during and after the treatment. They are interested in all the details of your health during the clinical trial. Our highly experienced and compassionate physicians and staff focus on patient safety and care.
Phases of Clinical Trials
On average, a new cancer drug has been studied for at least 6 years before it even makes it to clinical trials. Phases are the stages a clinical trial must go through before they are released to the general public. Every new treatment is tested in 3 or more phases of clinical trials to determine drug dose, safety and effectiveness. The main phases are Phase I, Phase II and Phase III. The different phases give doctors different information about the treatment being studied.
A person does not go through each phase of a clinical trial. You can join a clinical trial at any phase. You can always leave a clinical trial at any time for any reason. If you decide to leave the study, talk to your doctor first to go over the affects it may have on your health and what other treatment options are available for you.
The most critical phase due to the development of a new drug or treatment. The main goal is to determine how well it works against a particular type of cancer, along with safety, best uses, dosage, frequency of dosage and identify side effects.
Before you decide whether a clinical trial is right for you, make sure you know the facts. Clinical trials offer a lot of hope for many people with cancer. Nearly all of the cancer-fighting drugs and treatments currently available to patients exist because they were thoroughly tested in clinical trials. The best way to ensure you are making the right choice, is taking the time to get as much information as you need to help make that decision.
Below is a list of available clinical trials and cancer research opportunities through Millennium Physicians. Please talk with your doctor to discuss the treatment options available to you and their likely impact on your disease and quality of life.
Available Trials
Condition or Disease: Non-Small Cell Lung Cancer
Description: The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for their patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR).
Phase: III
Study Drug: Tegrisso + Alimta/Carbo
Sponsor: AstraZeneca
Condition or Disease: RET-fusion Non Small Cell Lung Cancer
Description: This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcome when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for patients with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease. Patients who have centrally confirmed progressive disease on the control arm have the option to crossover to pralsetinib.
Phase: III
Study Drug: Pralsetinib
Sponsor: Blueprint Medicines Corporation
Condition or Disease: Small Cell Lung Cancer
Description: This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing antitumor efficacy when administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line treatment for patients with newly diagnosed extensive-stage SCLC.
Phase: II
Study Drug: Atezolizumab + Trilaciclib
Sponsor: G1 Therapeutics, Inc.
Condition or Disease: Neoplasms
Description: This is a Phase 2, multicenter, open-label, multi-cohort study to assess safety and efficacy of CC-90011 in combination with nivolumab in subjects with small cell lung cancer or squamous non-small cell lung cancer who have progressed after 1 or 2 lines of therapies.
Phase: II
Study Drug: CC90011 + Nivolumab
Sponsor: Celgene
Condition or Disease: Metastatic Non-Small Cell Lung Cancer
Description: This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb). The primary hypotheses of this study are that pembrolizumab + lenvatinib (compared with docetaxel) prolongs: 1) overall survival (OS); and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR).
Phase: III
Study Drug: Pembro + Lenvatinib
Sponsor: Merck Sharp & Dohme Corp.
Condition or Disease: Non-Small Cell Lung Cancer
Description: The aim of this study is to determine if the Investigational Medicinal Product Tedopi (OSE2101) is more effective than standard treatment in treating patients with stage IIIB NSCLC unsuitable for radiotherapy or metastatic NSCLC in second- or third-line treatment.
Phase: III
Study Drug: OSE2101 vs Docetaxel or Pemetrexed
Sponsor: OSE Immunotherapeutics
Condition or Disease: Non-Small Cell Lung Cancer
Description: This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy in combination with checkpoint inhibitor therapy.
Phase: III
Study Drug: Sitravatinib (TAM-TKI)
Sponsor: Mirati Therapeutics Inc.
Condition or Disease: Non-Small Cell Lung Cancer
Description: This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of major pathological response.
Phase: III
Study Drug: Durvalumab Neo/Adjuvant
Sponsor: AstraZeneca
Condition or Disease: Colorectal Cancer
Description: The BESPOKE CRC study will prospectively enroll patients who have undergone surgery for stage II or III colorectal cancer (CRC) and who have residual formalin-fixed paraffin-embedded (FFPE) tissue available will provide FFPE and whole blood samples. Patients will receive SIGNATERA™ test results and may be recommended for adjuvant chemotherapy or observation by their treating clinician. Patients will be followed for up to two years with periodic whole blood collection. The study also has a control arm that will consist of matched Stage II or Stage III CRC cases that have a minimum of least 2 years clinical follow-up data.
Study Drug: CT DNA
Sponsor: Natera, Inc.
Condition or Disease: Gastric Cancer
Description: DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or durvalumab in HER2-positive advanced/metastatic gastric/gastroesophageal junction (GEJ) adenocarcinoma patients.
Phase: II
Study Drug: DS8201
Sponsor: AstraZeneca
Condition or Disease: Hepatocellular Carcinoma
Description: A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.
Phase: III
Study Drug: Durvalumab + Avastin
Sponsor: AstraZeneca
Condition or Disease: Hepatocellular Carcinoma
Description: A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma
Phase: III
Study Drug: Durvalumab + TACE/Avastin
Sponsor: AstraZeneca
Condition or Disease: Breast Cancer
Description: This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
Phase: III
Study Drug: Trastuzumab deruxtecan (DS-8201a) + Ado-trastuzumab emtansine (T-DM1)
Sponsor: Daiichi Sankyo, Inc.
Condition or Disease: Breast Cancer
Description: QT interval prolongation and neutropenia are considered to be important identified risks for ribociclib (Kisqali® Prescribing Information, Investigator Brochure). The approved dosing regimen of ribociclib is 600 mg daily (QD) on a 3 weeks on/1 week off schedule.
Phase: II
Study Drug: Ribociclib
Sponsor: Novartis Pharmaceuticals
Condition or Disease: Triple Negative Breast Neoplasms
Description: Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)
Phase: III
Study Drug: Capivasertib + Paclitaxel vs Paclitaxel
Sponsor: AstraZeneca
Condition or Disease: Multiple Myeloma
Description: The purpose of this study is to compare the efficacy (rate of very good partial response [VGPR] or better as best response as defined by the International Myeloma Working Group [IMWG] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab intravenous (Dara-IV) to evaluate daratumumab retreatment.
Phase: II
Study Drug: Daratumumab SQ
Sponsor: Janssen Research & Development, LLC
Condition or Disease: Multiple Myeloma
Description: The purpose of this study is to determine the progression-free survival (PFS) at 2 years for MM participants previously receiving a bortezomib-based induction regimen to IRD
Phase: IV
Study Drug: Ninlaro
Sponsor: Takeda
Condition or Disease: Prostate Cancer
Description: The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone.
Phase: III
Study Drug: Radium-223 and Docetaxel vs. Docetaxel
Sponsor: Memorial Sloan Kettering Cancer Center
Contact
Members of our clinical trials study team can tell you more about the types of research taking place at Millennium Physicians locations. If you have questions about a specific study, please contact our staff. If you would like assistance searching for clinical studies that match your interest, please contact your doctor.
Locations
North Houston
522 Timberdale Ln.
Houston, TX 77090
Shenandoah
The Woodlands
Phone