Phase 2
Completed N=158
A Study of Ramucirumab or Icrucumab in Colorectal Cancer
Source: ClinicalTrials.gov NCT01111604 ↗Enrolled (actual)
158
Serious AEs
26.8%
Results posted
Aug 2019
Primary outcomePrimary: Progression-Free Survival (PFS) — 18.4; 21.4; 15.9 Weeks
Summary
The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-Free Survival (PFS) |
18.4; 21.4; 15.9 | — |
| SECONDARY Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR]) |
14; 3.8; 3.8 | — |
| SECONDARY Overall Survival (OS) |
53.6; 41.7; 42.0 | — |
| SECONDARY Duration of Response (DoR) |
35.6; NA; NA | — |
| SECONDARY Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5 |
NA; 201 | — |
| SECONDARY Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5 |
53.6; 146 | — |
| SECONDARY Maximum Concentration (Cmax) at Day 8 |
— | — |
| SECONDARY Maximum Concentration (Cmax) at Day 15 |
— | — |
| SECONDARY Minimum Concentration (Cmin) at Day 1 |
— | — |
| SECONDARY Minimum Concentration (Cmin) at Day 4 |
— | — |
| SECONDARY Minimum Concentration (Cmin) at Day 8 |
— | — |
| SECONDARY Minimum Concentration (Cmin) at Day 15 |
— | — |
| SECONDARY Number of Participants With Serum Ramucirumab Antibody Assessment |
— | — |
| SECONDARY Serum Anti-Icrucumab Antibody Assessment |
— | — |
| SECONDARY Number of Participants With Adverse Events |
49; 52; 52; 11; 18; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI or CAPIRI [capecitabine + irinotecan], with or without bevacizumab)
- Age ≥ 18 years
- Life expectancy of ≥ 6 months
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry
- Agrees to adequate contraception during the study period and for 12 weeks after the last dose of study medication
- Provided signed informed consent
Exclusion Criteria
- Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the last dose of oxaliplatin was administered > 12 months prior to randomization)
- Has documented and/or symptomatic brain or leptomeningeal metastases
- Has an ongoing or active infection, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders
- On chronic non-topical corticosteroid treatment. A participant discontinuing such treatment > 3 months prior to randomization is eligible
- Has uncontrolled or poorly controlled hypertension on a standard regimen of antihypertensive therapy
- Has a concurrent active malignancy. A participant with previous history of malignancy is eligible, provided that he/she has been disease free for > 3 years
- If female, is pregnant (confirmed by serum beta human chorionic gonadotropin [βHCG] test) or lactating
- Has received a prior autologous or allogeneic organ or tissue transplantation
- Has undergone major surgery within 28 days prior to randomization
- Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization
- Has an elective or planned major surgery to be performed during the course of the trial
- Has a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention in the 12 months prior to randomization
Data sourced from ClinicalTrials.gov (NCT01111604). 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.