APHON CHEMOTHERAPY OVERVIEW EXAM
QUESTIONS AND ANSWERS 100%
CORRECT!!
, Pre-clinical Studies - ANSWER purpose is to determine safe starting dose for humans
Folic Acid - ANSWER Positive effect on kids w/ lymphoblastic leukemia
Clinical trials - ANSWER comparing 2+ therapeutic tx in ctl setting to evaluate effect of
intervention of specific disease/s
Clinical Trial phase 1 - ANSWER how much can you handle before breakdown?
determine max tolerated dose of drug or drug combo.
ID dose-limiting toxicities: highest dose for which incidence of dose limiting toxicities is
<33%
Clinical Trial Phase 1 Patient - ANSWER advanced disease, good organ function,
resistant to standard therapies
Clinical Trial phase 2 - ANSWER determines efficacy of new agent in tx of specific
cancer types and validate toxicity & dosage data. info r/t drug administration, acute
toxicity, & supporting care
Clinical Trial phase 2 Patient - ANSWER pt who show little to no response to prior tx
usually selected w/ normal organ function, measurable tumor size, reasonable life
expectancy & functional status.
Includes pt who have not been treated w/ investigational drug
Clinical Trial Phase 3 - ANSWER determine value of agent r/t existing tx. Measure
response, toxicity, survival & QOL
Clinical trial Phase 3 Patient - ANSWER large number of newly dx who receive tx and
observed over long period of time
Clinical Trial Phase 4 - ANSWER Occurs after agent is available in commercial market.
Efforts to decrease AE, toxicity w/ acceptable cure rate. Focuses more on long term
safety
Institutional Review Board - ANSWER Ensures the rights/welfare of humans are
protected, by signing informed consent and requires documentation of eligibility, tx,
modifications, toxicities, and outcome
QUESTIONS AND ANSWERS 100%
CORRECT!!
, Pre-clinical Studies - ANSWER purpose is to determine safe starting dose for humans
Folic Acid - ANSWER Positive effect on kids w/ lymphoblastic leukemia
Clinical trials - ANSWER comparing 2+ therapeutic tx in ctl setting to evaluate effect of
intervention of specific disease/s
Clinical Trial phase 1 - ANSWER how much can you handle before breakdown?
determine max tolerated dose of drug or drug combo.
ID dose-limiting toxicities: highest dose for which incidence of dose limiting toxicities is
<33%
Clinical Trial Phase 1 Patient - ANSWER advanced disease, good organ function,
resistant to standard therapies
Clinical Trial phase 2 - ANSWER determines efficacy of new agent in tx of specific
cancer types and validate toxicity & dosage data. info r/t drug administration, acute
toxicity, & supporting care
Clinical Trial phase 2 Patient - ANSWER pt who show little to no response to prior tx
usually selected w/ normal organ function, measurable tumor size, reasonable life
expectancy & functional status.
Includes pt who have not been treated w/ investigational drug
Clinical Trial Phase 3 - ANSWER determine value of agent r/t existing tx. Measure
response, toxicity, survival & QOL
Clinical trial Phase 3 Patient - ANSWER large number of newly dx who receive tx and
observed over long period of time
Clinical Trial Phase 4 - ANSWER Occurs after agent is available in commercial market.
Efforts to decrease AE, toxicity w/ acceptable cure rate. Focuses more on long term
safety
Institutional Review Board - ANSWER Ensures the rights/welfare of humans are
protected, by signing informed consent and requires documentation of eligibility, tx,
modifications, toxicities, and outcome
