Study Description
Screening
Study Centers
Contact/Consent
Oncology
Novartis Oncology shares a common mission: discover and develop innovative medicines to fight cancer. Innovative medicine begins with research. Our research approach is focused on discoveries within the study of genetics in cells and rational drug design. Drug design involves identifying the structure of a tumor and developing medicine that will specifically target it. Once a promising medicine has been identified, we work with leading investigators and patient volunteers in countries around the world to study the safety and efficacy of the agent.
Novartis is seeking people to participate in a clinical trial(s) testing the safety
and effectiveness of Novartis products. Novartis recommends that you consult your
doctor before participating in a clinical trial.
How to use this system:
The purpose of this system is to help connect interested study participants with clinical
research centers. The following is a brief outline explaining the main steps involved in
using this system. Please note that every step in this process is optional.
1. Select a clinical trial that you feel best suits your (or the participant's)
health condition.
2. Answer the screening questions to see if you (or the participant) meet
the preliminary qualifications for
the study. The answers to these questions
are not retained by this system.
3. Select a study center to contact for additional information about the
clinical trial.
4. Set up an account and agree to the terms of use for this system.
5. Submit your information to the study center you selected.
6. The study center may contact you and may ask more questions about your
(or the participant's) eligibility
for the study. The study center may invite you
(and the participant if applicable) to travel to the study center
for additional screening tests. Novartis cannot guarantee that you
will be contacted by the study center.
7. If you are eligible to participate in the study, then you will be required
to sign an
informed consent before enrolling in the study. An informed consent
is provided to you to help you understand the clinical trial, the nature of
the medical treatment (if any),
procedures and known risks involved, before you agree to participate in the study.
For more information about clinical trial participation, click here. Also, for additional information
about how Novartis helps to protect the privacy of the personal information that you provide to us, please
see the Novartis Privacy Policy.
Please review the details of the clinical trial(s) listed below and click on the one that you feel best suits
your (or the participant's) condition.
Ovarian Cancer Study CEPO906A2303
Novartis Oncology is conducting a clinical research study to find out if the study drug patupilone is safe, prolongs survival, and has any additional beneficial effects in patients with ovarian, primary fallopian, or primary peritoneal cancer who did not respond to chemotherapy or whose disease came back after chemotherapy. Pegylated liposomal doxorubicin is chemotherapy approved by the FDA for use in ovarian, primary fallopian, or primary peritoneal cancer and is a standard treatment for this type of cancer at this stage of the disease. Because we do not know which medicine is best, we need to make a comparison of the two products: pegylated liposomal doxorubicin and patupilone. Study patients may get either 10 mg/m2 patupilone once every three weeks or 50 mg/m2 of pegylated liposomal doxorubicin once every four weeks, intravenously (directly into a vein). Study patients will have a 50% chance of being assigned to receive either the study drug patupilone or pegylated liposomal doxorubicin. Patients are assigned to a particular treatment by an automatic system. Patients or doctors will not have a choice of which medication the patient will receive. The study drug, Patupilone, is a medicine which has not been approved by the FDA (US Food and Drug Administration) or the EMEA (European Medicines Agency).
Trial phase: Phase 3
Participation Duration: 1 hour visit to study site, every 3-4 wks for treatment and evaluations. After completion of study treatment, you will be asked to come to the study site every 3 months to see how you’re doing and follow the progress of your disease.
Protocol Number: CEPO906A2303
Breast Cancer Study CZOL446E2352
Novartis Oncology is conducting a study to find out if zoledronic acid is safe and effective for women who have been taking zoledronic acid for the past year and have breast cancer that has spread to the bone. The reason for this study is to find out whether zoledronic acid continues to decrease skeletal-related events (like breaking bones) after 9-20 doses during the previous 10 to 15 months. If it does continue to decrease them, then the study will examine which dose is better between treatment once a month or once every three months. If you agree to join this study you will be assigned randomly to one of three treatment groups which includes a treatment discontinuation group where participants will be required to have an infusion that contains no medicine. The study drug will be given to participants by intravenous infusion. Zoledronic acid is currently approved in the United States for cancer participants with Hypercalcemia of Malignancy (high calcium in the blood from cancer) and for treatment of cancer participants with multiple myeloma (a blood cancer). Zoledronic acid has also been approved for participants with confirmed bone mestastases (cancer that has spread to the bone) from other solid tumors (like breast cancer) to prevent skeletal related events. The FDA approval in the United States for participants with bone metastases is for zoledronic acid to be used for 12 months. This study will also look at how safe zoledronic acid is after one year.
Trial phase: Phase 3
Participation Duration: 15 visits to the study center over the 13 months, and the visits should last about 2 hours.
Protocol Number: CZOL446E2352
Malignant Melanoma Study CSTI571BUS255
Novartis Oncology is supporting a clinical study that is being sponsored and conducted by Dr. F. Stephen Hodi of the Dana-Farber Cancer Institute, to find out if the study drug imatinib mesylate (Gleevec®) is safe and effective for people, 18 years of age or older, who have metastatic acral lentiginous melanoma which is a form of skin cancer that commonly appears as a dark patch on the palms, soles, fingers, toes, under fingernails or toenails, or mucous membranes. Gleevec® has been approved for the treatment of certain types of cancers, however it is not approved for metastatic acral lentiginous melanoma.
Trial phase: Phase 2
Participation Duration: Participants will be asked to visit the study center a predetermined number of times over the course of a one year period.
Protocol Number: CSTI571BUS255
T-Cell Lymphoma Study CLBH589B2201
Novartis Oncology is conducting a clinical research study to compare the safety and effectiveness of an investigational drug for participants who are 18 years of age and older that have Cutaneous T-cell Lymphoma (CTCL), which is a rare disease where certain cells of the lymph system (T-lymphocytes) become cancerous and affect the skin. An “investigational drug”, means that it is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
Trial phase: Phase 2
Participation Duration: Participants will be required to take the investigational drug orally, once a day on Mondays, Wednesdays and Fridays.
Protocol Number: CLBH589B2201
Metastatic Colorectal Cancer Study CRAD001C2242
The purpose of this clinical research study is to determine the safety and effectiveness of an investigational drug in treating participants between the ages of 18 through 65 who have metastatic colorectal cancer. Participants will be assigned to one of three groups, each receiving a different dose of the investigation drug. In addition, every participant will receive infusions of cetuximab and irinotecan. Both cetuximab and irinotecan have been approved for treatment of metastatic colorectal cancer. An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
Trial phase: Phase 1
Participation Duration: Participants will be asked to take 6 to 14 tablets of the study medication once a week. Participants will also receive infusions once a week.
Protocol Number: CRAD001C2242
Acromegaly Study CSOM230C2305
The purpose of this clinical research study is to determine the most safe and effective dose of an investigational drug for participants who are at least 18 years old and have active acromegaly. An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
Trial phase: Phase 3
Participation Duration: Participants will be asked to visit the study center 18 times over 12 months to receive treatment once a month.
Protocol Number: CSOM230C2305
Cushing’s Disease Study CSOM230B2305
The purpose of this clinical research study is to evaluae the safety and efficacy of an investigational drug for participants 18 years of age and older who have ACTH-dependent Cushing’s disease. An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
Trial phase: Phase 3
Participation Duration: Participants will be required to inject themselves twice a day with the study medication and will be asked to visit the study center 17 times over 1 year.
Protocol Number: CSOM230B2305
Brain Metastases from Lung Cancer Study CEPO906A2227
Novartis Oncology is conducting a clinical research study to find out if the study drug, patupilone, is an effective and safe treatment for people who are 18 years or older and have non-small cell lung cancer that has spread to the brain, and that is recurrent in the brain after treatment. The research study is an open-label study, which means that everyone participating in the study will receive the study drug patupilone once every 3 weeks. Patupilone is given by intravenous infusion (directly into a vein) lasting approximately 20 minutes. Patients may remain in the study as long as they and the study doctor think it is in their best interest to participate. The study drug, patupilone, is an investigational drug which has not been approved by the FDA (US Food and Drug Administration) or the EMEA (European Medicines Agency) for the treatment of people with your medical condition.
Trial phase: Phase 2
Participation Duration: Study site visits approx. 2 times a month. The first visits at cycles 1 and 3 may require overnight stays. A final study visit must be performed 28 days after last administration of study drug for all patients regardless of reason for discontinuation.
Protocol Number: CEPO906A2227
Prostate Cancer Study CEPO906A2229
Novartis Oncology is conducting a clinical research study to evaluate the difference in effectiveness and safety between the study drug patupilone plus prednisone and the drug docetaxel, in people who have hormone refractory prostate cancer. The reason for this study is to find out which of these two medicines gives better relief of prostate cancer. Patupilone is a medicine which has not been approved by the FDA (US Food and Drug Administration) for the treatment of people with prostate cancer. Docetaxel is a medication approved by the FDA to treat breast cancer, non-small cell lung cancer and prostate cancer.
Trial phase: Phase 2
Participation Duration: Participants will visit the study site approximately once every three weeks for treatment and evaluations for 20 weeks. Each visit should take about 1-3 hours. If a participant has been discontinued from treatment for a reason other than progression of disease, they are required to visit the study site every three weeks for disease evaluation and every six weeks for radiological scans until progression of disease is documented.
Protocol Number: CEPO906A2229
RADIANT-3: Advanced Pancreatic Neuroendocrine Tumors (Islet Cell Tumors) Study CRAD001C2324
The purpose of this clinical research study is to determine if an investigational drug is safe and effective in people who have advanced pancreatic neuroendocrine tumors. This cancer is also known as islet cell carcinoma. The purpose of this clinical research study is to learn if the investigational drug can shrink or slow the growth of the tumors. In order to determine the safety and effectiveness of the investigational drug, the study doctor will monitor the physical state and well being of participants, evaluate changes in the size of their tumors, and perform laboratory tests. An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
Trial phase: Phase 3
Participation Duration: Participants will be asked to take 2 tablets (5 mg each) orally, once a day for a set number of days
Protocol Number: CRAD001C2324
HER2-positive Metastatic Breast Cancer Study CLBH589C2204
The purpose of this clinical trial is to find out if the study drug LBH589 is safe and has beneficial effects when in given in combination with trastuzumab (Herceptin®) in people who have HER2-positive Metastatic Breast Cancer who are no longer responding to the trastuzumab (Herceptin®) treatment or other treatments they have already been given. An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
Trial phase: Phase 2
Participation Duration: Participants will be asked to visit the study doctor’s office or clinic from 1 to 4 times every week for the first two months. Participants will only be asked to come to the doctor’s office once a week starting with the third month of the study. Each visit should take about 1-3 hours; however, on some days participants will be in the office for approximately 8 hours.
Protocol Number: CLBH589C2204
Advanced Non-small Cell Lung Cancer Study CASA404A2301
The purpose of this study is to determine if adding the study drug ASA404 to standard chemotherapy makes the cancer treatment more effective in patients with newly diagnosed advanced non-small cell lung cancer. The standard chemotherapy regimen that all patients receive in this study is paclitaxel plus carboplatin. Participants will also receive either ASA404 or a placebo (half will receive ASA404, half will receive placebo). The study drug ASA404 is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
Trial phase: Phase 3
Participation Duration: Participants will receive a maximum of 6 cycles of study treatment. Each treatment cycle is 21 days (3 weeks) long. Participants will return to their doctor’s office every 3 weeks so that their condition can be monitored. The number of treatment cycles for each participant depends on how they respond to treatment and whether they suffer from any side effects.
Protocol Number: CASA404A2301
Multiple Myeloma Study CLBH589B2206
The purpose of this clinical trial is to find out the effects, both positive and negative, of a study drug called LBH589 when administered together with oral lenalidomide and dexamethasone to people who have a form of bone marrow cancer called Multiple Myeloma that has not responded to prior treatments. The study drug LBH589 is being tested as part of this study and is currently not available for purchase on the market in any country.
Trial phase: Phase 1
Participation Duration: Participants will be required to take 3 drugs over a 28 day period. They will take oral LBH589 once-a-day on Monday, Wednesday, and Friday each week. In addition, they will take lenalidomide once-a-day, and dexamethasone once-a-day on specific days during the 28 day treatment cycle. Participants will be asked to come to the clinic one to four times each week. Each of these visits should take about 1-3 hours, but there are a few visits that may take up to 8 hours.
Protocol Number: CLBH589B2206
Multiple Myeloma Study CLBH589B2207
The purpose of this clinical trial is to find out the effects, both positive and negative, of a study drug called LBH589 when administered together with bortezomib to people who have a form of bone marrow cancer called Multiple Myeloma that has not responded to prior treatments. The study drug LBH589 is being tested as part of this study and is currently not available for purchase on the market in any country.
Trial phase: Phase 1
Participation Duration: Participants will take oral LBH589 once-a-day on Monday, Wednesday, and Friday each week. In addition, participants will receive an injection of bortezomib twice weekly for 2 weeks. Participants will be asked to come to the clinic for five visits in the first week of the study, with the frequency of visits reducing thereafter for the length of participation in the study. Each of these visits should take about 1-3 hours, but there are a few visits that may take up to 8 hours.
Protocol Number: CLBH589B2207
Prostate Cancer Study CLBH589C2208
The purpose of this clinical trial is to find out the effects, both good and bad, of a study drug called panobinostat (LBH589) when given to people that have hormone refractory prostate cancer (HRPC) that is no longer responding to treatments that have already been given. The study drug Panobinostat (LBH589) is a medicine which has not been approved by FDA or other Health Authorities for the treatment of any medical conditions. Panobinostat (LBH589) is being tested in this study but is currently not “on the market” (available for you to buy) in any country.
Trial phase: Phase 2
Participation Duration: Participants will be asked to visit the doctor’s office or clinic from 1 to 2 times every week for the first three weeks for treatment and evaluations. They will be asked to visit the doctor’s office once a week on treatment days starting in the fourth week of the study unless they experience any side effects from the study medications. Each visit should take about 1-3 hours; however, on day 1 of the first cycle, participants will be in the office for 9 to 10 hours.
Protocol Number: CLBH589C2208
Chronic Myelogenous Leukemia (CML) Study CAMN107AUS09
The purpose of this clinical trial is to determine if the study drug, nilotinib (Tasigna®), is safe and has beneficial effects in people who have chronic myelogenous leukemia (CML) in the chronic phase and a suboptimal molecular response to imatinib (Gleevec®). Nilotinib (Tasigna®), is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic-phase and accelerated-phase Philadelphia chromosome positive (Ph+) CML in adult patients who are resistant or intolerant to prior treatment including imatinib (Gleevec®).
Trial phase: Phase 2
Participation Duration: Participants will be taking the study drug daily for up to 5 years on this study. They will be required to return to the study doctor’s office at regular intervals so that their condition can be monitored and routine blood tests and safety evaluation can be carried out.
Protocol Number: CAMN107AUS09
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