Stopping rules employing response rates, time to progression, and early progressive disease for phase II oncology trials

Table 1 TTP and RR Thresholds Generated with fixed N while varying H _nul and H _alt (1-beta = 0.8, alpha = 0.05, censoring 0.05, n₁ = 15, n₂ = 15)

Response		Time to Progression		Stage 1 Drug Rejection		Stage 2 Drug Acceptance		Power	Alpha Error	EN_nul /PES_nul	EN_alt /PES_alt
r _nul	r _alt	ttp _nul	ttp _alt	r ₁	epd	r ₁+r ₂	ttp
0.05	0.2	3	6	≤ 0	≥ 5	≥ 5	≥ 5.25	0.815	0.035	26.8/0.21	29.7/0.02
0.05	0.2	3	7	≤ 0	≥ 5	≥ 5	≥ 6	0.828	0.02	26.8/0.22	29.8/0.01
0.05	0.2	4	7	≤ -1	≥ 16	≥ 5	≥ 6.25	0.821	0.074	30/0	30/0
0.05	0.2	4	8	≤ 0	≥ 4	≥ 5	≥ 7	0.812	0.035	26.8/0.21	29.6/0.02
0.05	0.2	5	8	≤ 0	≥ 9	≥ 5	≥ 7	0.825	0.15	29.99†/ 0.0002	29.99†/ 0.0005
0.05	0.2	6	9	≤ 0	≥ 10	≥ 5	≥ 8	0.816	0.2	29.99/ 0.00001	29.99/ 0.0001
0.1	0.3	3	7	≤ 2	≥ 5	≥ 7	≥ 6	0.854	0.03	24.4/0.37	29.5/0.03
0.1	0.3	4	7	≤ 2	≥ 4	≥ 7	≥ 6	0.829	0.09	28.9/0.38	24.4/0.07
0.1	0.3	4	8	≤ 1	≥ 4	≥ 7	≥ 6.75	0.86	0.055	26.2/0.25	29.6/0.03
0.2	0.4	5	8	≤ 1	≥ 7	≥ 10	≥ 6.75	0.867	0.23	29.97/ 0.002	29.99/ 0.0004
0.2	0.4	5	9	≤ 3	≥ 3	≥ 10	≥ 7.5	0.813	0.13	24.6/0.36	28.6/0.09
0.3	0.5	5	8	≤ 4	≥ 3	≥ 12	≥ 6.75	0.828	0.29	25.7/0.28	28.4/0.1
0.3	0.5	6	9	≤ 4	≥ 3	≥ 12	≥ 7.5	0.843	0.35	26.7/0.22	28.7/0.09

†Truncated, not rounded, value.
EN_nul = expected number of patients accrued if a drug meets the criteria of the null hypothesis
EN_alt = expected number of patients accrued if a drug meets the criteria of the alternate hypothesis
PES_nul = probability of stopping the trial after stage I if a drug meets the criteria of the null hypothesis
PES_alt = probability of stopping the trial after stage I if a drug meets the criteria of the alternate hypothesis

ISSN: 1471-2288