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NCT Number: NCT00862524

A Study of ARRY-334543 and Gemcitabine in Patients With Advanced Cancer and Pancreatic Cancer

This is a 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and gemcitabine.

The study has 2 parts. In the first part of the study, Phase 1, patients with advanced/metastatic solid tumors will receive increasing doses of study drug in combination with gemcitabine 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 24 patients from the US will be enrolled in Part 1 (Completed).

In the second part of the study, Phase 2, patients with metastatic pancreatic cancer will receive the best dose of study drug, in combination with gemcitabine, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).

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Key information

Conditions

Advanced Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Pinnacle Oncology/Hematology, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria (Part 1):

  • Histologically or cytologically confirmed diagnosis of a solid tumor suitable for treatment with gemcitabine.
  • No more than 3 prior anticancer regimens for advanced disease.
  • Measurable or evaluable, nonmeasurable disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Able to take and retain oral medications.
  • Additional criteria exist.

Key Exclusion Criteria (Part 1):

  • Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days).
  • Treatment with prior chemotherapy within 21 days of first dose of study drug.
  • Requiring IV alimentation.
  • Pregnancy or lactation.
  • Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
  • History of being unable to tolerate gemcitabine or any of its components.
  • Additional criteria exist.

Treatment and study plan

ARRY-334543, EGFR/ErbB2 inhibitor; oral

Drug

multiple dose, escalating

Gemcitabine, nucleoside analogue; intravenous

Drug

multiple dose, single schedule

Primary outcomes

  1. Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine.

    Time frame: Part 1

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

    Time frame: Part 1

  3. Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite.

    Time frame: Part 1

  4. Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks.

    Time frame: Part 2

Secondary outcomes

  1. Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response.

    Time frame: Part 1

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

    Time frame: Part 2

Sponsors and collaborators

Lead sponsor

Array BioPharma

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 17, 2009
Registry last updated
Oct 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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