Phase 3
Completed N=123
Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer
Source: ClinicalTrials.gov NCT02776683 ↗Enrolled (actual)
123
Serious AEs
26.8%
Results posted
Nov 2019
Primary outcomePrimary: Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs) in the Specified Categories Selected for Primary Endpoint Assessment — 58.5; 18.7; 12.2; 2.4 Percentage of participants (%)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The objective of this trial is to evaluate the safety and tolerability of BI 695502 in combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy (when applicable). As well as to evaluate the following efficacy parameters: Progression-free survival (PFS), objective response rate (proportion of patients with complete response [CR] plus partial response [PR]), overall survival (OS), duration of response (DOR), time to progression (TTP).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs) in the Specified Categories Selected for Primary Endpoint Assessment |
58.5; 18.7; 12.2; 2.4; 28.5; 9.8 | — |
| SECONDARY Duration of Response (DOR) as Assessed by Central Imaging Review |
9.1 | — |
| SECONDARY Time to Progression (TTP) as Assessed by Central Imaging Review |
11.1 | — |
| SECONDARY Objective Response (OR) Rate as Assessed by Central Imaging Review |
61.0 | — |
| SECONDARY Overall Survival (OS) Time |
19.4 | — |
| SECONDARY Progression-Free Survival (PFS) Time as Assessed by Central Imaging Review |
10.5 | — |
Eligibility Criteria
Inclusion criteria
- Males and females aged >=18 years (for Japan only: Age >=20 years at time of signing Informed Consent Form) with histologically confirmed metastatic colorectal cancer (mCRC).
- Metastatic disease not amenable to surgical curative treatment and eligible to receive therapy with mFOLFOX6 (Leucovorin/5-Fluorouracil/Oxaliplatin) + bevacizumab.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate hepatic, renal and bone marrow function.
- Further inclusion criteria apply.
Exclusion criteria
- Prior systemic therapy for metastatic disease
- Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular endothelial growth factor (VEGF) or VEGF receptors, including Avastin® or Avastin® biosimilar
- Previous malignancy other than Colorectal cancer (CRC) in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix
- Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 6 weeks prior to start of study treatment
- Any unresolved toxicity > Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy)
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- A thrombotic or hemorrhagic event <=6 months prior to screening (includes hemoptysis, Gastrointestinal (GI) bleeding, hematemesis, central nervous system hemorrhage, epistaxis, vaginal bleeding, cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and coronary artery disease)
- Further exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02776683). 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.