Study Description
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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.
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.
Breast Cancer (Bone Metastases) Study - E2352
A randomized, double-blind, stratified, multicenter trial to test the continued efficacy and safety (every 4 weeks vs. every 12 weeks) of an existing therapy in people with documented bone metastases from breast cancer.
Trial phase: Phase 3
Participation Duration: Study will require 15 visits to the study center over a period of 13 months. Visits may last approximately 2 hours.
Protocol Number: CZOL446E2352
Malignant Melanoma Study - US255
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 a Novartis study drug is safe and effective for people with metastatic acral lentiginous melanoma. An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
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
Multiple Myeloma Study - B2207
The purpose of this phase Ib, multi-center, open-label study will be to evaluate the maximum tolerated dose of a Novartis investigational drug on a continuous schedule in combination with an existing therapy in adults suffering from multiple myeloma. An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 1
Participation Duration: Participation in this study will require 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
Carcinoid Syndrome Study - C2303
This research study will compare a Novartis investigative drug to octreotide LAR to determine which offers the best relief from diarrhea or flushing symptoms in people with carcinoid syndrome, who have not found relief from other treatment(s). An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 3
Participation Duration: Participants will be asked to visit the study site 10 times over about 10 months. Each visit should take about 2 hours. During the first month, participants will be required to make 3 visits, and then one visit per month thereafter. At the end of the study, participants will have an option to continue the study (in the extension portion) for another 24 months.
Protocol Number: CSOM230C2303
Mantle Cell Lymphoma Study - N2201
The purpose of this open-label, single-arm phase II study is to evaluate the safety and efficacy of a Novartis investigational drug in people with mantle cell lymphoma where the disease has progressed despite standard therapy. An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 2
Participation Duration: Participants will be required to visit the study center twice per month during the first 3 months and, then every 28 days until treatment with the study drug is finished.
Protocol Number: CRAD001N2201
Kidney Cancer (Clear Cell Carcinoma) Study - L2201
The purpose of this randomized, open-label, multi-center phase II study is to compare the effects of combining a Novartis investigational drug with an existing therapy, when treating people with metastatic clear cell carcinoma of the kidney (Kidney Cancer). An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 2
Participation Duration: Participants will be required to visit their study site every two weeks for approximately two years. One group will be required to inject themselves three times a week and return to the study site every two weeks for an additional infusion treatment. Another group, will be required to take two tablets every day and return to the site every two weeks for an additional infusion treatment.
Protocol Number: CRAD001L2201
Lung Cancer Study CASA404A2302
The purpose of this phase III, randomized, double-blind, placebo-controlled multi-center study is to assess the effects of a Novartis investigational drug in combination with a standard therapy in second-line treatment of people with locally advanced or metastatic (Stage IIIb/IV) non-small cell lung cancer (NSCLC). An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 3
Participation Duration: This study is anticipated to last approximately 27 months. Eligible participants will be assigned into 1 of 2 possible groups: group 1 will receive the investigational drug plus standard therapy, while group 2 will receive a placebo (a dummy substance that has no effect on your body) plus standard therapy. Participants will be required to visit the study center to receive a treatment and/or evaluation every 3 weeks.
Protocol Number: CASA404A2302
Metastatic Unresectable Gastrointestinal Stromal Tumors (GIST) Study - G2301
A randomized, open-label, multi-center phase III study to evaluate the efficacy and safety of a Novartis investigational drug versus an approved therapy in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST). An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 3
Participation Duration: Participants enrolling in this study will be required to visit the study center 4 times within the first month. Follow up visits will be required every 3 months until the trial is complete (up to 10 years).
Protocol Number: CAMN107G2301
Chronic Myelogenous Leukemia (CML) Study - AUS09
A multi-center, open-label, exploratory research study for people suffering with CML in the chronic phase (CML-CP), who achieved a complete cytogenetic response (CCyR) while on an established therapy, but have a suboptimal molecular response.
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
Metastatic Breast Cancer Trial - Y2301
The purpose of this phase III study is to compare efficacy and safety of a Novartis investigational drug along with an additional therapy in treating postmenopausal women with estrogen receptor positive (ER+) locally advanced or metastatic breast cancer refractory to nonsteroidal aromatase inhibitors (NAI). An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 3
Participation Duration: The planned duration of this trial will be 24 weeks, with post assessment visits every 6 weeks until trial completion.
Protocol Number: CRAD001Y2301
Gastrointestinal Stromal Tumor (GIST) Study - US282
A non-randomized, open-label, multi-center phase II investigational study of an existing therapy in patients at significant risk for recurrence following complete resection of primary gastrointestinal stromal tumor (GIST).
Trial phase: Phase 2
Participation Duration: Participants will be required to visit the study center 3 times within the first month, and then once every 4 months until the study is completed. At the conclusion of your treatment, the study center will contact you twice a year for five years.
Protocol Number: CSTI571BUS282
Hodgkin's Lymphoma (Refractory/Relapsed) Study - NUS65
The purpose of this open-label, single-arm phase II clinical trial is to assess if a Novartis investigational drug is effective at slowing the progression of cancer in patients with refractory or relapsed classical Hodgkin's lymphoma. An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 2
Participation Duration: Participants will be asked to visit the study center once every 14 days during the first three months of treatment, and then once every 28 days until treatment is complete.
Protocol Number: CRAD001NUS65
HER2 Positive Breast Cancer Trial - J2301
The purpose of this randomized, phase III, double-blind, placebo-controlled, multicenter study is to evaluate the safety and efficacy of combining a Novartis investigational drug with standard chemotherapy medicines in women with HER2 positive (HER2+) locally advanced or metastatic breast cancer. An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 3
Participation Duration: Participants will be asked to visit a study center 4 times a month for a period of 6 months or until the disease progresses
Protocol Number: CRAD001J2301
Diffuse Large B-Cell Lymphoma (DLBCL) Study - N2301
A randomized, double-blind, placebo-controlled, multicenter research study that will test how safe and effective a Novartis investigational drug is at slowing or preventing the recurrence of diffuse large B-cell lymphoma compared to placebo. An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 3
Participation Duration: The planned treatment duration for this trial is 1 year, and post treatment assessments will be required for a minimum of 5 years.
Protocol Number: CRAD001N2301
HER2 Advanced or Metastatic Breast Cancer Trial - W2301
The purpose of this randomized, phase III, double-blind, placebo-controlled multicenter study is to evaluate if adding a Novartis investigational drug to an existing combination therapy offers a more positive “progression-free” result in pretreated women with HER2/Neu Over-Expressing Locally Advanced or Metastatic Breast Cancer. An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 3
Participation Duration: Participants will be asked to visit the study center Once a week for a period of 6-9 months or until the disease has progressed.
Protocol Number: CRAD001W2301
Advanced Gastric Cancer Study - R2301
The purpose of this randomized, double-blind, multi-center, phase III study is to assess the safety and efficacy of a Novartis investigational drug in patients with advanced gastric cancer which has progressed after one or two lines of prior chemotherapy. An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 3
Participation Duration: All patients will take two 5mg tablets of an investigative drug or matching placebo once daily in the morning. There is no set number of days for participation duration. Instead, patients will be treated with study drug until disease progression, unacceptable toxicity, or until the patient withdraws consent.
Protocol Number: CRAD001R2301
Kidney Cancer (Renal Cell Carcinoma) Study - L2202
An open-label, multicenter phase II study to compare the efficacy and safety of a Novartis investigational drug as first-line followed by second-line approved therapy versus the approved therapy as first-line followed by a second-line Novartis investigational drug in the treatment of patients with metastatic renal cell carcinoma. An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 2
Participation Duration: Participants will be required to visit the study center 2 times during each 42 day treatment cycle. Participation duration will last until disease progression, unacceptable toxicity, or discontinuation from treatment for any other reason.
Protocol Number: CRAD001L2202
Liver Cancer Study CRAD001O2301 - DNU
The purpose of this study is to measure the safety and effectiveness of a Novartis investigational drug in patients with advanced liver cancer.
This study drug is an investigational drug, which means it is being tested and is not approved for the treatment of people with liver cancer in the United States by the U.S. Food and Drug Administration (FDA).
Trial phase: Phase 3
Participation Duration: Participants will be required to visit the study center every 3 weeks for as long as they are receiving the study drug.
Protocol Number: CRAD001O2301- DNU
Multiple Myeloma (Refractory/Relapsed) Study - D2308
The purpose of this prospective, multinational, randomized, double-blind, placebo-controlled, parallel group Phase III study is to compare the results in progression-free survival of 2 combination therapies in people with previously treated multiple myeloma whose disease has recurred or progressed. An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 3
Participation Duration: Participation in this study will require going to the doctors office or clinic 5 times in the first two weeks and then 4 times per cycle every study treatment cycle (each study cycle is 21 days long). Each visit is 1 - 4 hours.
Protocol Number: CLBH589D2308
Chronic Myelogenous Leukemia (CML) - AUS17
The purpose of this study is to assess changes in chronic low-grade non-hematologic adverse events experienced by people with Philadelphia Chromosome positive (PH+) Chronic Myelogenous Leukemia in chronic phase when given a Novartis investigational drug after switching therapy. 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 4
Participation Duration: Participation in this study will include 12 visits to your doctor's office/clinic or study center for about 1.5 years.
Protocol Number: CAMN107AUS17
Myelofibrosis Study - BUS58
This Novartis study will assess the safety and efficacy of a Novartis investigational drug as a single agent in the treatment of Primary Myelofibrosis, Post-Polycythemia Vera and Post-Essential Thrombocythemia. There will be two cohorts - patients with JAK2 mutation and patients without JAK2 mutation. An "investigational drug" is a drug that is being clinically tested and is not approved for sale or use in the United States by the Food and Drug Administration (FDA), for the indication in which it is being studied.
Trial phase: Phase 2
Participation Duration: Participation in this study requires you to come to the doctor's office/clinic for a screening visit and then weekly for the first 4 weeks that you take the study drug treatment. Thereafter, you will be asked to come to the clinic two times every cycle for the next two cycles and once per cycle for the remainder of the trial.
Protocol Number: CLBH589BUS58
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