A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

This phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial in participants with locally advanced/inoperable or metastatic pancreatic cancer, and will investigate 2 different doses of LY2495655 in combination with standard of care chemotherapy.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Overall Survival (OS) [Baseline to Death from Any Cause (Up to 23 months)]. Median, months (90% Confidence Interval). 300 mg LY2495655 + Chemotherapy (n=41): 8.02 (5.95 to 10.02); 100 mg LY2495655 + Chemotherapy (n=43): 9.82 (5.85 to 13.54); Placebo + Chemotherapy (n=41): 10.45 (8.38 to 14.49).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Progression Free Survival (PFS) [Baseline to Disease Progression or Death from Any Cause (Up to 16 months)]. Median, months (90% Confidence Interval). 300 mg LY2495655 + Chemotherapy (n=41): 4.90 (3.32 to 6.01); 100 mg LY2495655 + Chemotherapy (n=43): 6.87 (5.36 to 7.89); Placebo + Chemotherapy (n=41): 8.21 (4.99 to 9.36).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Percentage of Participants With Tumor Response Rate (RR) [Baseline to Disease Progression (Up to 11 months)]. Number, percentage of participants. 300 mg LY2495655 + Chemotherapy (n=41): 22; 100 mg LY2495655 + Chemotherapy (n=43): 25.6; Placebo + Chemotherapy (n=41): 26.8.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Duration of Response [First CR or PR to Disease Progression (Up to 11 months)]. Median, months (90% Confidence Interval). 300 mg LY2495655 + Chemotherapy (n=41): 5.86 (3.91 to 5.98); 100 mg LY2495655 + Chemotherapy (n=43): 8.02 (3.09 to 9.63); Placebo + Chemotherapy (n=41): 9.20 (9.03 to 10.45).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Lean Body Mass [Baseline, Cycles 3, 5, 7, 9 and 11; Day 1]. Mean, grams (g) (Standard Deviation). Baseline: 300 mg LY2495655 + Chemotherapy (n=41): 43742.92 (10460.69); 100 mg LY2495655 + Chemotherapy (n=42): 44307.12 (9853.15); Placebo + Chemotherapy (n=41): 42870.99 (8971.73). Cycle 3: 300 mg LY2495655 + Chemotherapy (n=41): 42629.79 (10263.53); 100 mg LY2495655 + Chemotherapy (n=42): 44250.67 (11600.33); Placebo + Chemotherapy (n=41): 42282.45 (8523.35). Cycle 5: 300 mg LY2495655 + Chemotherapy (n=41): 43121.85 (11249.28); 100 mg LY2495655 + Chemotherapy (n=42): 45697.82 (12035.96); Placebo + Chemotherapy (n=41): 43041.45 (7649.44). Cycle 7: 300 mg LY2495655 + Chemotherapy (n=41): 44407.02 (11685.15); 100 mg LY2495655 + Chemotherapy (n=42): 45486.34 (11424.00); Placebo + Chemotherapy (n=41): 45997.59 (9429.50). Cycle 9: 300 mg LY2495655 + Chemotherapy (n=41): 46879.22 (12316.64); 100 mg LY2495655 + Chemotherapy (n=42): 43656.49 (12335.08); Placebo + Chemotherapy (n=41): 43405.26 (7217.48). Cycle 11: 300 mg LY2495655 + Chemotherapy (n=41): 46155.53 (9984.09); 100 mg LY2495655 + Chemotherapy (n=42): 433316.42 (11436.93); Placebo + Chemotherapy (n=41): 45667.63 (8100.86).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Physical Performance Measures Using Hand Grip Strength [Baseline, Cycles 2, 4, 6, 8 and 10; Day 1]. Mean, kilogram (kg) (Standard Deviation). Baseline: 300 mg LY2495655 + Chemotherapy (n=41): 28.59 (11.99); 100 mg LY2495655 + Chemotherapy (n=42): 29.00 (11.35); Placebo + Chemotherapy (n=41): 27.46 (12.54). Cycle 2: 300 mg LY2495655 + Chemotherapy (n=41): 25.90 (13.49); 100 mg LY2495655 + Chemotherapy (n=42): 26.70 (12.27); Placebo + Chemotherapy (n=41): 25.26 (11.80). Cycle 4: 300 mg LY2495655 + Chemotherapy (n=41): 25.56 (13.67); 100 mg LY2495655 + Chemotherapy (n=42): 24.47 (10.46); Placebo + Chemotherapy (n=41): 28.02 (13.10). Cycle 6: 300 mg LY2495655 + Chemotherapy (n=41): 26.58 (9.65); 100 mg LY2495655 + Chemotherapy (n=42): 26.32 (14.33); Placebo + Chemotherapy (n=41): 27.43 (14.01). Cycle 8: 300 mg LY2495655 + Chemotherapy (n=41): 27.89 (11.46); 100 mg LY2495655 + Chemotherapy (n=42): 26.22 (14.92); Placebo + Chemotherapy (n=41): 25.44 (12.05). Cycle 10: 300 mg LY2495655 + Chemotherapy (n=41): 25.13 (13.15); 100 mg LY2495655 + Chemotherapy (n=42): 29.23 (14.81); Placebo + Chemotherapy (n=41): 33.27 (14.25).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Physical Performance Measures Using the Time Up and Go (TUG) Test [Baseline, Cycles 2, 4, 6, 8 and 10; Day 1]. Mean, seconds (Standard Deviation). Baseline: 300 mg LY2495655 + Chemotherapy (n=41): 10.70 (5.06); 100 mg LY2495655 + Chemotherapy (n=42): 10.16 (4.53); Placebo + Chemotherapy (n=41): 10.04 (4.04). Cycle 2: 300 mg LY2495655 + Chemotherapy (n=41): 9.19 (2.60); 100 mg LY2495655 + Chemotherapy (n=42): 10.15 (3.93); Placebo + Chemotherapy (n=41): 10.64 (4.46). Cycle 4: 300 mg LY2495655 + Chemotherapy (n=41): 9.33 (3.23); 100 mg LY2495655 + Chemotherapy (n=42): 12.19 (8.96); Placebo + Chemotherapy (n=41): 9.18 (2.60). Cycle 6: 300 mg LY2495655 + Chemotherapy (n=41): 10.14 (2.02); 100 mg LY2495655 + Chemotherapy (n=42): 8.84 (2.94); Placebo + Chemotherapy (n=41): 9.77 (3.96). Cycle 8: 300 mg LY2495655 + Chemotherapy (n=41): 9.28 (2.51); 100 mg LY2495655 + Chemotherapy (n=42): 7.26 (2.13); Placebo + Chemotherapy (n=41): 9.03 (4.30). Cycle 10: 300 mg LY2495655 + Chemotherapy (n=41): 10.56 (1.40); 100 mg LY2495655 + Chemotherapy (n=42): 7.75 (2.38); Placebo + Chemotherapy (n=41): 9.76 (5.75).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Physical Performance Measures Using the 6 Minute Walk Test [Baseline, Cycles 2, 4, 6, 8 and 10; Day 1]. Mean, meter (Standard Deviation). Baseline: 300 mg LY2495655 + Chemotherapy (n=41): 351.49 (115.18); 100 mg LY2495655 + Chemotherapy (n=42): 382.49 (131.41); Placebo + Chemotherapy (n=41): 381.62 (94.68). Cycle 2: 300 mg LY2495655 + Chemotherapy (n=41): 368.08 (137.65); 100 mg LY2495655 + Chemotherapy (n=42): 361.53 (143.70); Placebo + Chemotherapy (n=41): 376.31 (107.25). Cycle 4: 300 mg LY2495655 + Chemotherapy (n=41): 379.90 (208.66); 100 mg LY2495655 + Chemotherapy (n=42): 323.79 (140.26); Placebo + Chemotherapy (n=41): 386.48 (126.56). Cycle 6: 300 mg LY2495655 + Chemotherapy (n=41): 354.20 (104.74); 100 mg LY2495655 + Chemotherapy (n=42): 416.30 (102.49); Placebo + Chemotherapy (n=41): 376.45 (132.05). Cycle 8: 300 mg LY2495655 + Chemotherapy (n=41): 365.00 (75.71); 100 mg LY2495655 + Chemotherapy (n=42): 347.32 (203.49); Placebo + Chemotherapy (n=41): 392.13 (113.43). Cycle 10: 300 mg LY2495655 + Chemotherapy (n=41): 308.19 (57.23); 100 mg LY2495655 + Chemotherapy (n=42): 372.15 (172.40); Placebo + Chemotherapy (n=41): 391.41 (143.18).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Physical Performance Measures Using Stair Climbing Time (StC) [Baseline, Cycles 3, 5, 7, 9 and 11; Day 1]. Mean, joule/second (Standard Deviation). Baseline: 300 mg LY2495655 + Chemotherapy (n=41): 211.25 (129.57); 100 mg LY2495655 + Chemotherapy (n=42): 206.92 (110.52); Placebo + Chemotherapy (n=41): 178.25 (65.18). Cycle 3: 300 mg LY2495655 + Chemotherapy (n=41): 203.24 (113.76); 100 mg LY2495655 + Chemotherapy (n=42): 203.70 (87.82); Placebo + Chemotherapy (n=41): 170.49 (76.52). Cycle 5: 300 mg LY2495655 + Chemotherapy (n=41): 230.23 (135.31); 100 mg LY2495655 + Chemotherapy (n=42): 211.99 (93.00); Placebo + Chemotherapy (n=41): 186.55 (95.20). Cycle 7: 300 mg LY2495655 + Chemotherapy (n=41): 198.24 (83.19); 100 mg LY2495655 + Chemotherapy (n=42): 235.82 (111.95); Placebo + Chemotherapy (n=41): 200.79 (130.74). Cycle 9: 300 mg LY2495655 + Chemotherapy (n=41): 217.82 (131.34); 100 mg LY2495655 + Chemotherapy (n=42): 197.49 (102.51); Placebo + Chemotherapy (n=41): 160.59 (87.60). Cycle 11: 300 mg LY2495655 + Chemotherapy (n=41): 193.24 (96.70); 100 mg LY2495655 + Chemotherapy (n=42): 221.59 (107.49); Placebo + Chemotherapy (n=41): 188.78 (188.78).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Patient Reported Outcomes (PRO) [Baseline, Cycles 2, 4, 6, 8 and 10; Day 1].

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Change in Pain Scale Physical Functioning [Baseline, Cycles 2, 4, 6, 8 and 10; Day 1]. Mean, units on a scale (Standard Deviation). Baseline: 300 mg LY2495655 + Chemotherapy (n=41): 6.62 (2.23); 100 mg LY2495655 + Chemotherapy (n=43): 6.81 (2.55); Placebo + Chemotherapy (n=41): 5.89 (2.54). Cycle 2: 300 mg LY2495655 + Chemotherapy (n=41): 4.48 (2.09); 100 mg LY2495655 + Chemotherapy (n=43): 5.63 (2.81); Placebo + Chemotherapy (n=41): 5.04 (2.03). Cycle 4: 300 mg LY2495655 + Chemotherapy (n=41): 5.33 (1.91); 100 mg LY2495655 + Chemotherapy (n=43): 4.78 (2.02); Placebo + Chemotherapy (n=41): 4.83 (2.50). Cycle 6: 300 mg LY2495655 + Chemotherapy (n=41): 4.38 (1.51); 100 mg LY2495655 + Chemotherapy (n=43): 4.65 (2.29); Placebo + Chemotherapy (n=41): 4.25 (1.91). Cycle 8: 300 mg LY2495655 + Chemotherapy (n=41): 4.14 (1.46); 100 mg LY2495655 + Chemotherapy (n=43): 5.85 (2.44); Placebo + Chemotherapy (n=41): 5.00 (2.26). Cycle 10: 300 mg LY2495655 + Chemotherapy (n=41): 4.57 (2.57); 100 mg LY2495655 + Chemotherapy (n=43): 5.58 (2.87); Placebo + Chemotherapy (n=41): 3.55 (1.92).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Anti-LY2495655 Antibodies [Cycle 1, Day 1 and Day 29 (Pre-Dose); Cycle 6 Day 1]. Count Of Participants, Participants. 300 mg LY2495655 + Chemotherapy (n=41): 0; 100 mg LY2495655 + Chemotherapy (n=43): 1; Placebo + Chemotherapy (n=41): 1.