CompletedPhase 1

A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers

United States26 participantsStarted 2011-03

Plain-language summary

This is a Phase 1 study during which patients with advanced cancer will receive investigational study drug ARRY-382. Patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in this study.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: * A histologically or cytologically confirmed diagnosis of advanced or metastatic solid cancer refractory to standard treatment, for which no standard therapy is available or for which the patient refuses standard therapy. * Measurable disease or evaluable, nonmeasurable disease. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2. * Hemoglobin ≥ 9.0 g/dL, ANC \> 1500/uL and platelet count ≥ 100,000/uL. * AST/serum glutamic oxaloacetic transaminase (SGOT) and ALT/serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 × the upper limit of normal (ULN). * Bilirubin ≤ ULN. * Serum creatinine ≤ 1.5 × ULN. * Potassium, magnesium and calcium (corrected calcium when serum albumin levels are abnormal) within the normal range. * Additional criteria exist. Key Exclusion Criteria: * 12-lead ECG demonstrating a mean QTcF \> 450 msec (triplicate assessment) at the Screening Visit or history/evidence of long QT syndrome. * History of acute coronary syndromes, including unstable angina, coronary angioplasty, or stenting, within the past 24 weeks. * Use of concomitant medications that prolong the QT/QTc interval, as assessed by the Investigator, within 14 days prior to first dose of study drug. * Use of concomitant medication that is a strong CYP3A inhibitor or inducer within 14 days prior to first dose of study drug. * Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system. * Un…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests and electrocardiograms.

Timeframe: Safety will be characterized for the duration of time that each patient stays on study; estimated one year.

Establish the maximum tolerated dose (MTD) of study drug.

Timeframe: The MTD will be based on Cycle 1 (28 days).

Characterize the plasma pharmacokinetics (PK) of study drug and its metabolites.

Timeframe: Safety will be characterized for the duration of time that each patient stays on study; estimated one year.

Trial details

NCT IDNCT01316822

SponsorArray Biopharma, now a wholly owned subsidiary of Pfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-10

View on ClinicalTrials.gov More Metastatic Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests and electrocardiograms.

Timeframe: Safety will be characterized for the duration of time that each patient stays on study; estimated one year.

Establish the maximum tolerated dose (MTD) of study drug.

Timeframe: The MTD will be based on Cycle 1 (28 days).

Characterize the plasma pharmacokinetics (PK) of study drug and its metabolites.

Timeframe: Safety will be characterized for the duration of time that each patient stays on study; estimated one year.