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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2020-05-06

Brief Summary

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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.

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Detailed Description

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Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CCX872-B

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

Group Type EXPERIMENTAL

CCX872-B

Intervention Type DRUG

Tablets (oral administration)

Interventions

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CCX872-B

Tablets (oral administration)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No