Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer
- Registration Number
- NCT02776683
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 123
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All patients BI 695502 - All patients Avastin -
- Primary Outcome Measures
Name Time Method Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs) in the Specified Categories Selected for Primary Endpoint Assessment From baseline up to 18 weeks after the last dose of trial medication prior to the Switch Visit. Maximum duration of up to 32 treatment cycles + safety follow up (up to 82 weeks overall). The primary safety endpoint of the trial was patients with any of the following selected adverse events (AEs):
* Infusion reactions (anaphylactic/hypersensitivity/infusion-related reactions),
* Thromboembolic events (arterial or venous),
* Gastrointestinal perforations,
* Hypertension,
* Proteinuria,
* Pulmonary hemorrhage
* All hemorrhages (including pulmonary hemorrhages)
* Wound-healing complications/abscess/fistulas
* Posterior reversible encephalopathy syndrome
* Ovarian failure. All AEs with an onset between start of treatment and end of the residual effect period (REP), a period of 18 weeks after the last dose of trial medication were considered for the primary safety analysis. Confidence interval was calculated using Wilson score method.
- Secondary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Time as Assessed by Central Imaging Review Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks). PFS was defined as the time from first administration of trial medication until disease progression as assessed by central imaging review or death due to any cause. Disease progression was assessed according to RECIST 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. PFS was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method.
Duration of Response (DOR) as Assessed by Central Imaging Review Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks). DOR was the time from first documented Complete Response (CR) (CR is disappearance of all target lesions) or Partial Response (PR) (PR is at least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters) until time of progression as assessed by central imaging review per Response evaluation criteria in solid tumors (RECIST) 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. DOR was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method.
Time to Progression (TTP) as Assessed by Central Imaging Review Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks). TTP was defined as the time from first administration of trial medication to the date of tumor progression as assessed by central imaging review per RECIST 1.1 (RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment.). TTP was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method.
Objective Response (OR) Rate as Assessed by Central Imaging Review Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks). OR rate was defined as the percentage of patients who achieved at least one visit response of CR (CR is disappearance of all target lesions) or PR (PR is at least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters) after the start of treatment. The response criteria evaluation was carried out according to RECIST 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Confidence interval was calculated using Wilson score method. The definition for OR (CR/PR) extends until disease progression/ death/ unacceptable toxicity/ end of the trial, whichever occurred earlier. However for "Duration of response" this censoring does not apply. Hence the apparent discrepancy.
OR = CR + PR.Overall Survival (OS) Time From date of first dose of trial medication until last date of trial medication + 18 weeks (REP), up to a maximum of 32 treatment cycles + safety follow up (up to 82 weeks overall). OS was defined as the time from first administration of trial medication until death from any cause. OS was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method.
Trial Locations
- Locations (41)
Sumy Regional Oncology Center
🇺🇦Sumy, Ukraine
The Oncology Institute of Hope and Innovation
🇺🇸Anaheim, California, United States
Oncology Hematology Care
🇺🇸Cincinnati, Ohio, United States
Jananese Foundation for Cancer Research
🇯🇵Tokyo, Koto-ku, Japan
Tyler Hematology-Oncology, PA
🇺🇸Tyler, Texas, United States
Mayo Clinic-Arizona
🇺🇸Phoenix, Arizona, United States
Pacific Cancer Medical Center, Inc.
🇺🇸Anaheim, California, United States
Ashland Bellefonte Cancer Center
🇺🇸Ashland, Kentucky, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
Willamette Valley Cancer Institute and Research Center
🇺🇸Springfield, Oregon, United States
Texas Oncology, P.A.
🇺🇸Tyler, Texas, United States
Texas Oncology, PA,
🇺🇸Amarillo, Texas, United States
Oncology Consultants, P.A.
🇺🇸Houston, Texas, United States
Texas Oncology, PA
🇺🇸Mesquite, Texas, United States
Texas Oncology-San Antonio Northeast
🇺🇸San Antonio, Texas, United States
Texas Oncology San Antonio Medical Center
🇺🇸San Antonio, Texas, United States
Texas Oncology, P.A., Deke Slayton Cancer Center
🇺🇸Webster, Texas, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Chiba Cancer Center
🇯🇵Chiba, Chiba, Japan
National Hospital Organization Shikoku Cancer Center
🇯🇵Ehime, Matsuyama, Japan
Kagawa University Hospital
🇯🇵Kagawa, Kita-gun, Japan
Hokkaido University Hospital
🇯🇵Hokkaido, Sapporo, Japan
Osaka University Hospital
🇯🇵Osaka, Suita, Japan
Japan Organization of Occupational Health and Safety Kansai Rosai Hospital
🇯🇵Hyogo, Amagasaki, Japan
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
Hospital Duran i Reynals
🇪🇸L'Hospitalet de Llobregat, Spain
CI Chernivtsi RC Oncological Dispensary Bukovinian SMU
🇺🇦Chernivtsi, Ukraine
Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council
🇺🇦Dnipropetrovsk, Ukraine
Regional Clinical Oncological Dispensary, Ivano-Frankivsk
🇺🇦Ivano-Frankivsk, Ukraine
CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent.
🇺🇦Lviv, Ukraine
Vinnytsia Regional Clinical Oncological Dispensary
🇺🇦Vinnytsia, Ukraine
Northwest Cancer Specialists PC
🇺🇸Portland, Oregon, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
National Institute of Cancer
🇺🇦Kyiv, Ukraine
Poltava Regional Clinical Oncological Dispensary, Poltava
🇺🇦Poltava, Ukraine
CI of PH Kharkiv CCH #2
🇺🇦Kharkiv, Ukraine
Treatment-Diagnostic CTR of Private Enterprise, Kirovohrad
🇺🇦Kirovohrad, Ukraine
CI Kryvyi Rih Oncological Dispensary of DRC
🇺🇦Kryvyi Rih, Dnipropetrovsk, Ukraine