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

• Sponsor: ChemoCentryx (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02345408
• Collaborator: (none)
• Enrollment: 54
• Locations: 6
• Arm: 1
• Duration (Months): 63.1
• Patients Per Site: 9
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer	Drug: CCX872-B	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: N/A
• 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: Feb 1, 2015
• Actual Primary Completion Date: May 6, 2020
• Actual Study Completion Date: May 6, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. progression-free survival [24 weeks]

2. subject incidence of Grade 3 or 4 adverse events [24 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Saint Louis	Missouri	United States
2		Rochester	New York	United States
3		Amsterdam		Netherlands
4		Nijmegen		Netherlands
5	Netherland	Rotterdam		Netherlands
6		Sittard		Netherlands

Sponsors and Collaborators

• ChemoCentryx

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ChemoCentryx
• ClinicalTrials.gov Identifier: NCT02345408
• Other Study ID Numbers: CL002_872
• First Posted: Jan 26, 2015
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2022

• Additional relevant MeSH terms: Adenocarcinoma

Study Results

No Results Posted as of Mar 15, 2022