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Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer (INVICTAN®-3)

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 3

Conditions

Colorectal Neoplasms

Treatments

Drug: Avastin
Drug: BI 695502

Study type

Interventional

Funder types

Industry

Identifiers

NCT02776683
2015-003718-25 (EudraCT Number)
1302.3

Details and patient eligibility

About

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).

Enrollment

123 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

123 participants in 1 patient group

All patients
Experimental group
Treatment:
Drug: Avastin
Drug: BI 695502

Trial documents
2

Trial contacts and locations

46

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Data sourced from clinicaltrials.gov

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