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

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ClinicalTrials.gov Identifier: NCT02345408
Recruitment Status : Active, not recruiting
First Posted : January 26, 2015
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
ChemoCentryx

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: CCX872-B Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase 1b Study to Evaluate the Safety and Efficacy of CCX872-B in Patients With Pancreatic Adenocarcinoma
Study Start Date : February 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: CCX872-B
150 mg once or twice daily given orally for at least 12 weeks
Drug: CCX872-B
Tablets (oral administration)




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 24 weeks ]
  2. subject incidence of Grade 3 or 4 adverse events [ Time Frame: 24 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345408


Locations
United States, Missouri
Saint Louis, Missouri, United States
United States, New York
Rochester, New York, United States
Netherlands
Amsterdam, Netherlands
Nijmegen, Netherlands
Rotterdam, Netherlands
Sittard, Netherlands
Sponsors and Collaborators
ChemoCentryx

Responsible Party: ChemoCentryx
ClinicalTrials.gov Identifier: NCT02345408     History of Changes
Other Study ID Numbers: CL002_872
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: July 18, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases