Phase 2
Completed N=125
A Phase 2 Study of LY2495655 in Participants With Pancreatic Cancer
Source: ClinicalTrials.gov NCT01505530 ↗Enrolled (actual)
125
Serious AEs
65.3%
Results posted
Jun 2018
Primary outcomePrimary: Overall Survival (OS) — 8.02; 9.82; 10.45 months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
8.02; 9.82; 10.45 | — |
| SECONDARY Progression Free Survival (PFS) |
4.90; 6.87; 8.21 | — |
| SECONDARY Percentage of Participants With Tumor Response Rate (RR) |
22; 25.6; 26.8 | — |
| SECONDARY Duration of Response |
5.86; 8.02; 9.20 | — |
| SECONDARY Change in Lean Body Mass |
43742.92; 44307.12; 42870.99; 42629.79; 44250.67; 42282.45 | — |
| SECONDARY Change in Physical Performance Measures Using Hand Grip Strength |
28.59; 29.00; 27.46; 25.90; 26.70; 25.26 | — |
| SECONDARY Change in Physical Performance Measures Using the Time Up and Go (TUG) Test |
10.70; 10.16; 10.04; 9.19; 10.15; 10.64 | — |
| SECONDARY Change in Physical Performance Measures Using the 6 Minute Walk Test |
351.49; 382.49; 381.62; 368.08; 361.53; 376.31 | — |
| SECONDARY Change in Physical Performance Measures Using Stair Climbing Time (StC) |
211.25; 206.92; 178.25; 203.24; 203.70; 170.49 | — |
| SECONDARY Change in Patient Reported Outcomes (PRO) |
— | — |
| SECONDARY Change in Pain Scale Physical Functioning |
6.62; 6.81; 5.89; 4.48; 5.63; 5.04 | — |
| SECONDARY Number of Participants With Anti-LY2495655 Antibodies |
0; 1; 1 | — |
Eligibility Criteria
Inclusion:
- Unresectable or metastatic pancreas cancer; participants with previous radical surgery for pancreas cancer are eligible after progression is documented
- Participants may have received previous adjuvant treatment with gemcitabine with or without radiotherapy for pancreas cancer
- ECOG (Eastern Cooperative Oncology Group) Performance status ≤ 2
- Adequate organ function
- Have an estimated life expectancy of at least 12 weeks and in the judgment of the investigator, will be able to complete at least 2 cycles of treatment
- Ability to perform the indicated functional performance measures at baseline
Exclusion:
- Prior systemic therapy for unresectable/metastatic pancreas cancer
- Any medical or psychiatric condition, orthopedic or neuromuscular conditions that could limit participation or confound study results
- Currently taking medications that are considered both muscle building and performance enhancing (for example, androgen therapies, or anabolic steroids)
Data sourced from ClinicalTrials.gov (NCT01505530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.