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Phase 1b Study of CCX872-B in Patients With Pancreatic Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02345408
Recruitment Status : Active, not recruiting
First Posted : January 26, 2015
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx

Tracking Information
First Submitted Date  ICMJE January 20, 2015
First Posted Date  ICMJE January 26, 2015
Last Update Posted Date August 16, 2019
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
  • progression-free survival [ Time Frame: 24 weeks ]
  • subject incidence of Grade 3 or 4 adverse events [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1b Study of CCX872-B in Patients With Pancreatic Adenocarcinoma
Official Title  ICMJE An Open-label Phase 1b Study to Evaluate the Safety and Efficacy of CCX872-B in Patients With Pancreatic Adenocarcinoma
Brief Summary This is an open-label phase 1-b study to evaluate the safety and efficacy of CCX872-B in patients with pancreatic adenocarcinoma also receiving FOLFIRINOX chemotherapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE Drug: CCX872-B
Tablets (oral administration)
Study Arms  ICMJE Experimental: CCX872-B
150 mg once or twice daily given orally for at least 12 weeks
Intervention: Drug: CCX872-B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 20, 2015)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed non-resectable pancreatic adenocarcinoma with or without metastases
  • Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
  • Anticipated life expectancy ≥ 12 weeks
  • Radiographically measurable disease acc. to RECIST 1.1
  • Use of adequate contraception (as described in protocol)
  • Ability to provide written informed consent and comply with study requirements

Exclusion Criteria:

  • Received other cancer treatment or investigational drug within 4 weeks prior to screening
  • Women who are pregnant or breastfeeding
  • Had major surgery within 4 weeks of first dose of study drug
  • Inadequate liver, renal or bone marrow function within 2 weeks of first dose
  • Serious concurrent illness, altered medical status or any uncontrolled medical condition
  • Any infection requiring antibiotic or anti-viral treatment within 4 weeks of screening
  • Known active HIV, HBV or HCV infection
  • Inability to swallow tablets
  • History or presence of any medical condition or disease which, in the opinion of the investigator, may place the subject at unacceptable risk for study participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02345408
Other Study ID Numbers  ICMJE CL002_872
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ChemoCentryx
Study Sponsor  ICMJE ChemoCentryx
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ChemoCentryx
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP