Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors
A Multi-Center, Open Label, Phase 1/2 Study of CP-383, in Patients With Advanced or Metastatic Solid Tumors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
The goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383. The main questions if aims to answer are: * Does CP-383 slow or stop the growth of cancer in patients with advanced cancer * What medical problems do participants have when taking CP-383 Researchers will test CP-383 in all kinds of cancers at various dose levels to determine what the best dose is to study further. Researchers will also see if certain cancers that have gene mutations respond better to CP-383 Participants will: * Take CP-383 every day by mouth until the researcher learns whether CP-383 is helping slow or reduce the cancer growth * Visit the clinic weekly for the first 6 weeks for checkups and tests * Visit the clinic every 3 weeks thereafter for checkups and tests
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * Measurable or non measurable cancer that the research can assess for changes * Not eligible or able to take existing standard therapies for cancer * Availability of a part of a tumor for laboratory testing or willing to have a safe biopsy taken from a tumor * Diagnosed with locally advanced, recurrent or metastatic incurable disease * Part 1: any solid tumor (with the exception of brain cancer) that has progressed, standard therapy is no longer or has not helped the cancer, or is too toxic and for whom a clinical trial is an option for continued treatment * Part 1: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer, non-small cell lung cancer, pancreatic cancer, bladder cancer - some of these will have a specific gene mutation in the cancer * Part 1: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer * Part 2: specific advanced, metastatic tumor types will also be enrolled: colorectal cancer, small cell lung cancer, head and neck cancer - some of these will have a specific gene mutation in the cancer \_ Part 2: selected solid tumor cancer types (with the exception of brain cancers) that have a specific gene mutation in the cancer * Adequate blood and urine lab tests * Women and men of childbearing potential with adequate contraception * Provides written informed consent * Willing to comply with the requirements of the protocol Exclusion Criteria: * Inability to swallow pills * Known history of HIV, HCV, HBV unless cured, controlled with undetectable viral load * Active tumor in the brain * Clinically significant liver disease * Significant gastrointestinal diseases * History of other cancer within past 5 years with certain exceptions for cancers that are likely cured * Significant cardiac disease * Other diseases that are not well controlled that could make taking the drug unsafe * pregnant or lactating females * Exposure to certain anti-cancer or other drugs within a certain period before the start of study drug
Study sites (13)
CO
- Sarah Cannon Research Institute at HealthONE · Denver, CO 80218HealthOne Denver · Study contact · 720-754-2610 · cann.ddudenvergeneral@sarahcannon.comGerald Falchook, MD · Principal investigatorMore trials in Denver
FL
- Florida Cancer Specialists-Lake Nona · Orlando, FL 32827Elizabeth Gilmore · Study contact · 904-380-2410 · elizabeth.griffith@scri.comCesar Perez, MD · Principal investigatorMore trials in Orlando
MI
- START Midwest · Grand Rapids, MI 49546Colleen Armstrong · Study contact · 616-389-1905 · colleen.armstrong@startresearch.comSreenivasa Chandana, MD · Principal investigatorMore trials in Grand Rapids
MO
- Washington University · St Louis, MO 63110Sara Mitchum · Study contact · 314-273-8602 · saram@wustl.eduNikolaos Trikalinos, MD · Principal investigatorMore trials in St Louis
NC
- Carolina BioOncology Institute · Huntersville, NC 28078Hannah Wall · Study contact · 980-441-1148 · hwall@carolinabiooncology.orgNeel Gandhi, MD · Principal investigatorMore trials in Huntersville
NE
- Nebraska Cancer Specialists · Omaha, NE 68130Ashley Servais · Study contact · 402-955-2691 · aservais@nebraskacancer.comRalph Hauke, MD · Principal investigatorMore trials in Omaha
OH
- Cleveland Clinic · Cleveland, OH 44195Taussig Research · Study contact · 216-444-7923 · TaussigResearch@ccf.orgAlex Adjei, MD · Principal investigatorMore trials in Cleveland
- Taylor Cancer Research Center · Maumee, OH 43537Stephanie Ambrose, RN, BSN, CCRC · Study contact · 567-402-4502 ext. 7502 · SAmbrose@tcrcpt.orgMore trials in Maumee
PA
- University of Pennsylvania · Philadelphia, PA 19104Roger Cohen, MD · Study contact · 215-662-4469 · roger.cohen@pennmedicine.upenn.eduRoger Cohen, MD · Principal investigatorMore trials in Philadelphia
TX
- NEXT Oncology - Dallas · Dallas, TX 75039Mofopefoluwa Akinwale · Study contact · 972-893-8800 · fakinwale@nextoncology.comMichael Song, MD, PhD, PharmD · Principal investigatorMore trials in Dallas
- START San Antonio · San Antonio, TX 78229Isabel Jimenez · Study contact · 210-593-5265 · isabel.jimenez@startresearch.comKyriakos P. Papadopoulos, MD · Principal investigatorMore trials in San Antonio
UT
- START Mountain Region · West Valley City, UT 84119Marie Asay · Study contact · 801-907-4770 · marie.asay@startresearch.comWilliam McKean, MD, PhD · Principal investigatorMore trials in West Valley City
VA
- NEXT Virginia · Fairfax, VA 22031Maybelle De La Rosa · Study contact · 703-783-4518 · mdelarosa@nextoncology.comAlexander Spira, MD · Principal investigatorMore trials in Fairfax