A Phase II Clinical Study of BBI608 in Adult Patients With Advanced Colorectal Cancer

This study is currently recruiting participants.
Verified March 2014 by Boston Biomedical, Inc
Sponsor:
Information provided by (Responsible Party):
Boston Biomedical, Inc
ClinicalTrials.gov Identifier:
NCT01776307
First received: January 21, 2013
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

This is an open label study of BBI608 in combination with cetuximab, panitumumab or capecitabine in patients with advanced colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: BBI608 and cetuximab
Drug: BBI608 and panitumumab
Drug: BBI608 and capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Study of BBI608 in Adult Patients With Advanced Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Boston Biomedical, Inc:

Primary Outcome Measures:
  • Disease Control Rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Assessment of Disease Control Rate, defined as the proportion of patients with a documented complete response, partial response and stable disease based on RECIST, in patients with advanced colorectal cancer given BBI608 in combination with cetuximab, panitumumab or capecitabine


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: From date of randomization until the date of death, assessed up to 100 months ] [ Designated as safety issue: No ]
    Assessment of Overall Survival in patients with advanced colorectal cancer given BBI608 in combination with cetuximab, panitumumab or capecitabine

  • Progression Free Survival [ Time Frame: From date of randomization until the date of first documented progression or death, whichever comes first, assessed up to 100 months ] [ Designated as safety issue: No ]
    Assessment of Progression Free Survival in patients with advanced colorectal cancer given BBI608 in combination with cetuximab, panitumumab or capecitabine by performing tumor assessments every 8 weeks.

  • Safety [ Time Frame: Adverse events will be assessed at baseline, while the participant is taking BBI608, and for 30 days after stopping therapy. The average length of this duration is expected to be approximately 4 months. ] [ Designated as safety issue: Yes ]
    Assessment of safety of BBI608 given in combination with cetuximab, panitumumab or capecitabine to patients with advanced colorectal cancer by reporting of adverse events and serious adverse events

  • Pharmacokinetics [ Time Frame: On Day 5 and Day 26 in the cetuximab combination arm; on Day 8 and 22 in the panitumumab combination arm; and on Day 8 and 21 in the capecitabine combination arm ] [ Designated as safety issue: No ]
    Observe the area under the plasma concentration versus time curve of BBI608 in combination with cetuximab, BBI608 in combination with panitumumab, and BBI608 in combination with capecitabine

  • Pharmacodynamics [ Time Frame: At baseline and at 4 hours after administration of BBI608 morning dose on Day 8 ] [ Designated as safety issue: No ]
    Pharmacodynamic assessments to analyze biomarkers in tumor tissues will be performed in patients when tumor biopsy with a minimally invasive procedure is deemed possible by Investigator.


Estimated Enrollment: 66
Study Start Date: March 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BBI608 in combination with cetuximab Drug: BBI608 and cetuximab
BBI608 is administered at 500 mg po bid continuously and cetuximab will be administered IV on day 5 at 400 mg/m2 intravenous infusion over 120 minutes as the initial dose, then weekly at 250mg/m2 over 60-minutes at subsequent cycles.
Other Name: Erbitux
Experimental: BBI608 in combination with panitumumab Drug: BBI608 and panitumumab
BBI608 is administered at 500 mg po bid continuously and panitumumab will be administered IV on day 8 and 22 of each 28 day cycle at 6 mg/kg over 60 minutes.
Other Name: Vectibix
Experimental: BBI608 in combination with capecitabine Drug: BBI608 and capecitabine
BBI608 is administered at 500 mg po bid continuously and capecitabine will be administered orally at 1000 mg/m2 bid daily on days 8-21 every three weeks.
Other Name: Xeloda

Detailed Description:

This is an open label, multi-center, Phase II study of BBI608 administered in combination with either cetuximab, or panitumumab, or capecitabine. A cycle will consist of daily and continuous oral administration of BBI608 for four weeks in combination with either cetuximab, or panitumumab, or capecitabine.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH), Good Clinical Practice(GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures.
  • A histologically or cytologically confirmed colorectal cancer that is metastatic, unresectable, or recurrent.
  • Patients must have received at least 2 regimens containing 5-Fluorouracil,oxaliplatin, or irinotecan.
  • Patients to be enrolled in the Cetuximab or Panitumumab combination arms must have colorectal cancer which is K-Ras wild-type.
  • ≥ 18 years of age.
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
  • Karnofsky performance Status ≥ 70%
  • Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI608 dose.
  • Females of childbearing potential must have a negative serum pregnancy test.
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤1.5 × upper limit of normal(ULN), or ≤ 2.5 × ULN with metastatic liver disease.
  • Hemoglobin (Hgb) ≥ 10 g/dl.
  • Total bilirubin ≤ 1.5 × ULN.
  • Creatinine ≤ 1.5 × ULN or creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
  • Absolute neutrophil count ≥ 1.5 x 10^9/L.
  • Platelets ≥ 100 x 10^9/L.
  • Life expectancy ≥ 3 months.

Exclusion Criteria:

  • Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose with the exception for a single dose radiation up to 8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days before beginning the administration of BBI608.
  • Surgery within 4 weeks prior to first dose.
  • Any known symptomatic brain metastases requiring steroids. Patients with treated brain metastases must be stable for 4 weeks after completion of that treatment, with image documentation required. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
  • Pregnant or breastfeeding
  • Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)
  • Unable or unwilling to swallow BBI608 capsules daily.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776307

Locations
United States, Ohio
The Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Sanaa Tahiri    614-293-5894    Sanaa.Tahiri@osumc.edu   
Principal Investigator: Taios Bekaii-Saab, MD         
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Melissa Kirsch, RN    215-349-5785    Melissa.kirsch@uphs.upenn.edu   
Principal Investigator: Peter O'Dwyer, MD         
United States, South Carolina
Institute for Translational Oncology Research, Greenville Hospital System Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jan Kueber, RN    864-455-3600    jkueber@ghs.org   
Principal Investigator: William J. Edenfield, MD         
Sponsors and Collaborators
Boston Biomedical, Inc
Investigators
Principal Investigator: William J. Edenfield, MD Institute for Translational Oncology Research, Greenville Hospital System
  More Information

No publications provided

Responsible Party: Boston Biomedical, Inc
ClinicalTrials.gov Identifier: NCT01776307     History of Changes
Other Study ID Numbers: BBI608-224
Study First Received: January 21, 2013
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Biomedical, Inc:
BBI608

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014