A new DRUG TRIALS SNAPSHOT is now available.
Ga-68-DOTATOC is a drug for the detection of specific types of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs).
NETs are rare tumors that develop in certain hormone-producing cells of the body’s neuro-endocrine system
Ga-68-DOTATOC is injected into a vein (intravenous) in preparation for an imaging test (called positron emission tomography scan or PET scan) to help detect the tumor.
See more Drug Trials Snapshots or contact us with questions at Snapshots@fda.hhs.gov.
Drug Trials Snapshots: Ga-68-DOTATOC
Ga-68-DOTATOC
UHC – PET Imaging Center
Approval date: August 21, 2019
UHC – PET Imaging Center
Approval date: August 21, 2019
DRUG TRIALS SNAPSHOT SUMMARY:
What is the drug for?
Ga-68-DOTATOC is a drug for the detection of specific types of tumors called somatostatin receptor positive neuro-endocrine tumors (NETs).
NETs are rare tumors that develop in certain hormone-producing cells of the body’s neuro-endocrine system.
How is this drug used?
Ga-68-DOTATOC is injected into a vein (intravenous) in preparation for an imaging test (called positron emission tomography scan or PET scan) to help detect the tumor.
What are the benefits of this drug?
Ga-68-DOTATOC shows the sites of NETs. In Trials 1 and 2, Ga-68-DOTATOC correctly identified NETS about 90%-92% of the time.
Were there any differences in how well the drug worked in clinical trials among sex, race and age?
- Sex: Ga-68-DOTATOC worked similarly in males and females.
- Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in how Ga-68-DOTATOC worked among races could not be determined.
- Age: Ga-68-DOTATOC worked similarly in patients younger and older than 65 years of age.
What are the possible side effects?
Ga-68-DOTATOC is a radioactive drug which may increase the risk of lifetime radiation exposure.
The most common adverse reactions were nausea, itching, and flushing.
Were there any differences in side effects among sex, race and age?
- Sex: The occurrence of side effects was similar among males and females.
- Race: The majority of patients were White. The number of patients in other races was limited; therefore, differences in the occurrence of side effects among races could not be determined.
- Age: The occurrence of side effects was similar in patients 18 to 64 years of age and those greater than 65 years of age. The number of patients less than 18 years of age was limited; therefore, differences in the occurrence of side effects among patients less than 18 years of age could not be determined.
WHO WAS IN THE CLINICAL TRIALS?
Who participated in the clinical trials?
The FDA approved Ga-68-DOTATOC based on evidence from three clinical trials (Trial 1/NCT#1619865, Trial 2/NCT#1869725, Trial 3/NCT#2441062) of 334 known or suspected neuro-endocrine tumors. The trials were conducted in the United States.
Table 9 summarizes demographics for the patients used to evaluate the benefits of Ga-68-DOTATOC in trials 1 and 2 (efficacy population).
The figure below summarizes how many males and females were used to evaluate safety in trials 1, 2, and 3 (safety population).
Figure 1. Baseline Demographics by Sex (safety population)
FDA Review
Figure 2 and Table 1 summarize the percentage of patients by race used to evaluate safety in the clinical trials.
Figure 2. Baseline Demographics by Race (safety population)
FDA Review
Table 1. Demographics of Trials by Race (safety population)
| Race | Number of Patients | Percentage of Patients |
|---|---|---|
| White | 314 | 94% |
| Black or African American | 5 | 2% |
| Asian | 4 | 1% |
| American Indian or Alaska Native | 1 | Less than 1% |
| Other | 7 | 2% |
| Missing | 3 | 1% |
FDA Review
Figure 3 summarizes the percentage of patients by age group in the clinical trials used to evaluate safety.
Figure 3. Baseline Demographics by Age
FDA Review
How were the trials designed?
The benefit and safety of Ga-68-DOTATOC in detecting neuro-endocrine tumors was evaluated in three clinical trials. Patients had known or suspected neuroendocrine tumors. All patients received a single intravenous dose of Ga-68 DOTATOC. Images were read by two readers. In all trials, the image readers did not know whether the patients had neuroendocrine tumors.
In Trials 1 and 2, the benefit of Ga-68-DOTATOC was assessed by comparing the accuracy of Ga-68-DOTATOC images to detect neuroendocrine tumors in patients whose NETs status was known using a tumor biopsy or other imaging techniques.
Patients in Trial 3 were primarily evaluated for side effects.
GLOSSARY
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.
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