Cancer Drug Clinical Trials 4/7

Front 1

What is the starting dose of experimental chemo in humans?

Back 1

1/10 the TD in mouse
1/6 the highest non-toxic dose in dog or monkey

Front 2

What is the Modified Fibonacci method?

Back 2

Most commonly used dose escalation method in PHASE I trials
initial, then % above preceding dose
2n, 100
3.3n, 67
5n, 50
40
33
33
33

Front 3

Common selection criteria for entry into Phase I trial:

Back 3

At least 18y/o
Histologically confirmed dx of any malignant solid tumor
DO NOT NEED measurable disease
Life expenctancy AT LEAST 12 weeks
Karnofsky Performance status of at least 70%
Adequate organ function
No history of seizure disorder requiring active tx
NO MALIGNANCY OF CNS
No ischemic event within preceding 6mo
No other therapies, including investigational
No chemo within 4 weeks prior
CANNOT HAVE radiation tx
Female pts cannot be of childbearing potential
ONLY OTHER MEDS must be for paint control or comfort or life-threatening problems
MUST sign an informed consent form

Front 4

What is the Maximally Tolerated Dose?

Back 4

One dose below the Dose Limiting Toxicity

Front 5

When does a Phase I trial end?

Back 5

Dose Limiting Toxicities
Maximally Tolerated Dose (one below DLT)

and any hint of anti-tumor activity

Front 6

Phase II trial

Back 6

FIXED DOSE of a drug
Pure efficacy trial
Need to see at least 3/25 patients with positive response to go on to Phase III

Front 7

Phase III trial

Back 7

Drug is compared to standard of care
Or drug is added to standard of care