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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CCX872-B
Sponsored by
ChemoCentryx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Netherland

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CCX872-B

Arm Description

150 mg once or twice daily given orally for at least 12 weeks

Outcomes

Primary Outcome Measures

progression-free survival
subject incidence of Grade 3 or 4 adverse events

Secondary Outcome Measures

Full Information

First Posted
January 20, 2015
Last Updated
March 14, 2022
Sponsor
ChemoCentryx
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1. Study Identification

Unique Protocol Identification Number
NCT02345408
Brief Title
Phase 1b Study of CCX872-B in Patients With Pancreatic Adenocarcinoma
Official Title
An Open-label Phase 1b Study to Evaluate the Safety and Efficacy of CCX872-B in Patients With Pancreatic Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
May 6, 2020 (Actual)
Study Completion Date
May 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ChemoCentryx

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CCX872-B
Arm Type
Experimental
Arm Description
150 mg once or twice daily given orally for at least 12 weeks
Intervention Type
Drug
Intervention Name(s)
CCX872-B
Intervention Description
Tablets (oral administration)
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
24 weeks
Title
subject incidence of Grade 3 or 4 adverse events
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Saint Louis
State/Province
Missouri
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Amsterdam
Country
Netherlands
City
Nijmegen
Country
Netherlands
Facility Name
Netherland
City
Rotterdam
Country
Netherlands
City
Sittard
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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