Phase 2
Completed N=232
EMD 525797 in Combination With Cetuximab and Irinotecan in K-ras Wild Type Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT01008475 ↗Enrolled (actual)
232
Serious AEs
43.9%
Results posted
Mar 2016
Primary outcomePrimary: Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity) — 0; 0; 0; 0 subjects
Summary
The purpose of this study is to assess the safety and clinical activity of the experimental drug EMD 525797 (study drug), a monoclonal antibody targeting alfa integrins, in combination with irinotecan and cetuximab in K-ras wildtype metastatic colorectal cancer patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Part: Number of Subjects Experiencing DLTs (Dose Limiting Toxicity) |
0; 0; 0; 0 | — |
| PRIMARY Randomized Part: Progression Free Survival (PFS) |
5.6; 5.4; 5.6 | — |
| SECONDARY Overall Survival (OS) Time |
11.6; 15.0; 14.4 | — |
| SECONDARY Time to Progression (TTP) |
5.8; 5.6; 6.5 | — |
| SECONDARY Number of Subjects With Tumor Response |
2; 1; 0; 17; 19; 18 | — |
| SECONDARY Time to Treatment Failure (TTF) |
5.2; 4.3; 4.8 | — |
Eligibility Criteria
Inclusion Criteria
Subjects with histologically confirmed kras wildtype (WT) colorectal carcinoma (CRC) with documented distant metastasis
- Prior oxaliplatin/fluoropyrimidine-containing regimen for the first-line treatment of metastatic disease
- Failed an oxaliplatin regimen for metastatic colorectal carcinoma (mCRC). Failure is defined as either progressive disease (PD) (clinical or radiologic) within 6 months of the last dose of any agent of an oxaliplatin-based regimen or intolerance to an oxaliplatin regimen. Intolerance to an oxaliplatin regimen is defined as discontinuation due to any of the following: severe allergic reaction, persistent severe neurotoxicity, or delayed recovery from toxicity preventing retreatment
- At least 1 radiographically documented measurable lesion in a previously non irradiated area according to Response Evaluation Criteria In Solid Tumors (RECIST, Version 1.0), i.e., this lesion must be adequately measurable in at least 1 dimension (longest diameter to be recorded) as greater than or equal to (>=) 2 centimeter (cm) by conventional techniques or >=1 cm by spiral computed tomography (CT) scan
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or Karnofsky performance status (KPS) >= 80 percent (%)
- Absolute Neutrophil Count (ANC) >=1.5 x 10^9/Liter
- Platelets >=100 x 10^9/Liter
- Hemoglobin >=9 gram per deciliter (g/dL) (without transfusions)
- Bilirubin less than or equal to ( =50 milliliter per minute (mL/min)
- International Nationalized Ratio (INR), and partial thromboplastin time (PTT) within normal limits
- Sodium and potassium within normal limits or =160 millimeter of mercury (mmHg) and/or diastolic blood pressure >=100 mmHg under resting conditions
- History of coagulation disorder associated with bleeding or recurrent thrombotic events
- History of recent peptic ulcer disease (endoscopically proven gastric, duodenal or esophageal ulcer) within 6 months of trial treatment start
- Chronic inflammatory bowel disease, or acute/chronic ileus
- Active infection (requiring i.v. antibiotics), including active tuberculosis, active or chronic Hepatitis B or C, or ongoing HIV infection
Data sourced from ClinicalTrials.gov (NCT01008475). 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.