NCT00710736

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2008

Typical duration for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

2.8 years

First QC Date

July 2, 2008

Last Update Submit

October 2, 2020

Conditions

Advanced Cancer

Outcome Measures

Primary Outcomes (3)

  • 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 (2)

  • 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.

    Duration of study

Study Arms (1)

ARRY-334543 + capecitabine

EXPERIMENTAL
Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oralDrug: Capecitabine, 5-fluorouracil prodrug; oral

Interventions

ARRY-334543, EGFR/ErbB2 inhibitor; oralDRUG

multiple dose, escalating

ARRY-334543 + capecitabine
Capecitabine, 5-fluorouracil prodrug; oralDRUG

multiple dose, single schedule

ARRY-334543 + capecitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

British Columbia Cancer Agency- Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Interventions

ARRY-334543Capecitabine

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 4, 2008

Study Start

June 1, 2008

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

October 6, 2020

Record last verified: 2020-10

Locations

CA(2)US(2)