A Study of ARRY-334543 and Capecitabine in Patients With... | NCT00710736

Studies
A Study of ARRY-334543 and Capecitabine in Patients With Advanced Cancer

NCT00710736

Sponsor

Array Biopharma, now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Oct 6, 2020Actual

Enrollment

29Actual

Phase

Phase 1

Conditions

Advanced Cancer

Interventions

ARRY-334543, EGFR/ErbB2 inhibitor; oral
Capecitabine, 5-fluorouracil prodrug; oral

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Jul 2, 2008

First Submission Date that Met QC Criteria

Jul 2, 2008

First Posted Date

Jul 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2020

Last Update Posted Date

Oct 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and capecitabine. Patients will receive increasing doses of study drug in combination with capecitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 30 patients from the US and Canada will be enrolled in this study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARRY-334543 + capecitabine	Experimental		Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oral Drug: Capecitabine, 5-fluorouracil prodrug; oral

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARRY-334543, EGFR/ErbB2 inhibitor; oral	Drug	multiple dose, escalating	ARRY-334543 + capecitabine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Establish the maximum tolerated dose (MTD) of study drug in combination with capecitabine.		Duration of study
Characterize the safety profile of study drug in combination with capecitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.		Duration of study
Characterize the pharmacokinetics (PK) of study drug and capecitabine.		Duration of study

Secondary Outcomes

Measure	Description	Time Frame
Assess the efficacy of the study drug in combination with capecitabine in terms of tumor response and changes in serological tumor markers.		Duration of study
Assess potential predictive biomarkers of clinical activity for the study drug in combination with capecitabine.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Histologically or cytologically confirmed diagnosis of any advanced/metastatic cancer suitable for treatment with capecitabine. Pancreatic cancer is not allowed and patients with gastric or gastroesophageal junction (GEJ) cancer are only eligible if prior treatment did not include a total gastrectomy.
Target lesions may be in a previously irradiated field only if progression of the lesion has been clearly documented.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
Must be able to take and retain oral medications.
Additional criteria exist.

Key Exclusion Criteria:

Active concomitant malignancies.
Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days).
Known dihydropyrimidine dehydrogenase (DPD) deficiency.
Requiring intravenous (IV) alimentation.
Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
Pregnancy or lactation.
Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
Anti-EGFR and/or ErbB2 small molecule targeted therapy or hormonal anticancer therapy within 14 days prior to first dose of study drug.
History of any hypersensitivity to or intolerance of capecitabine or any of its components, or to fluorouracil or any fluoropyrimidine therapy.
Additional criteria exist.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado Cancer Center		Aurora	Colorado	80045	United States
Roswell Park Cancer Institute

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines