NCT00833326

Brief Summary

This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and docetaxel (with prophylactic growth factor support). Patients will receive increasing doses of study drug in combination with docetaxel 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 will be enrolled in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

3 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

January 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

1.5 years

First QC Date

January 29, 2009

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 docetaxel.

    Duration of study

  • Characterize the safety profile of study drug in combination with docetaxel in terms of adverse events, clinical laboratory tests and electrocardiograms.

    Duration of study

  • Characterize the pharmacokinetics (PK) of study drug and docetaxel.

    Duration of study

Secondary Outcomes (1)

  • Assess the efficacy of the study drug in combination with docetaxel in terms of tumor response.

    Duration of study

Study Arms (1)

ARRY-334543 + docetaxel + prophylactic growth factors

EXPERIMENTAL
Drug: ARRY-334543, EGFR/ErbB2 inhibitor; oralDrug: Docetaxel, mitotic inhibitor; intravenousDrug: Prophylactic growth factors; subcutaneous

Interventions

ARRY-334543, EGFR/ErbB2 inhibitor; oralDRUG

multiple dose, escalating

ARRY-334543 + docetaxel + prophylactic growth factors
Docetaxel, mitotic inhibitor; intravenousDRUG

multiple dose, single schedule

ARRY-334543 + docetaxel + prophylactic growth factors
Prophylactic growth factors; subcutaneousDRUG

standard of care

ARRY-334543 + docetaxel + prophylactic growth factors

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 solid tumor suitable for treatment with docetaxel.
  • Tumor recurred or progressed following at least one line of chemotherapy, except if no standard of care exists or if the patient refuses standard of care treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
  • Must be able to take and retain oral medications.
  • Other 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 prior to study start).
  • Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
  • Requiring intravenous (IV) alimentation.
  • Pregnancy or lactation.
  • Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
  • Anti-ErbB1 and/or ErbB2 targeted therapy or anticancer hormonal therapy within 14 days prior to first dose of study drug.
  • History of hypersensitivity to or intolerance of docetaxel.
  • Other criteria exist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Mayo Cancer Center

Rochester, Minnesota, 55905, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Interventions

ARRY-334543DocetaxelAntimitotic AgentsInjections, Subcutaneous

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesMitosis ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesAntineoplastic AgentsTherapeutic UsesInjectionsDrug Administration RoutesDrug TherapyTherapeutics

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

January 29, 2009

First Posted

February 2, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

October 6, 2020

Record last verified: 2020-10

Locations

US(3)