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Phase I Study of CPI-300 in Patients With Advanced Tumors (CPI-300)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04808453
Recruitment Status : Recruiting
First Posted : March 22, 2021
Last Update Posted : July 20, 2022
Information provided by (Responsible Party):
Coordination Pharmaceuticals, Inc.

Brief Summary:
This is a prospective, open-label, single arm, non-randomized study of CPI-300 in patients with advanced tumors. CPI-300 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD).

Condition or disease Intervention/treatment Phase
Advanced Tumors Drug: CPI-300 Phase 1

Detailed Description:

Up to 6 dose levels of CPI-300 will be tested. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intravenous injection of CPI-300 within 28 days:

  • Grade 4 or greater treatment related adverse events
  • Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (including nausea, vomiting or diarrhea lasting more than 72 hours)

Blood samples will be drawn to determine drug blood concentrations for pharmacokinetic assessment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: accelerated titration method followed by a conventional 3 + 3 dose escalation study design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-300 Via Intravenous Infusion in Patients With Advanced Solid Tumors
Actual Study Start Date : June 15, 2021
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : December 15, 2022

Arm Intervention/treatment
Experimental: CPI-300
Dose Escalation Group: CPI-300 will be administered via intravenous infusion once every 2 weeks for up to 6 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design
Drug: CPI-300
CPI-300 will be administered via intravenous infusion on Day 1 of a 14-Day cycle

Primary Outcome Measures :
  1. Safety [ Time Frame: 28 days ]
    To determine the maximum tolerated dose (MTD), which is defined as the highest dose level at which number of patients reporting a dose limiting toxicity (DLT) is less than or equal to 33%

Secondary Outcome Measures :
  1. Clinical Benefit [ Time Frame: 28 Days and additional CPI-300 treatments till disease progression or intolerability ]
    To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%)

  2. Adverse Effect [ Time Frame: 28 Days and additional CPI-300 treatment till disease progression or intolerability ]
    To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE

  3. Maximum Plasma Concentration (Cmax) [ Time Frame: 8 Days ]
    To evaluate maximum plasma concentration (Cmax) of CPI-300 in patients tested

  4. Area Under the Curve (AUC) [ Time Frame: 8 Days ]
    To evaluate area under the curve (AUC) of CPI-300 in patients tested

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have a histologically or cytologically confirmed diagnosis of advanced solid tumor
  • Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy
  • Have an ECOG performance status of 0-1
  • Have adequate bone marrow reserve, liver and renal function
  • Be reasonably recovered from preceding major surgery or no major surgery within 4 weeks prior to the start of Day 1 treatment
  • Have a negative pregnancy test for females with child bearing age at screening and should not be breast feeding
  • Be willing to abstain from sexual activity or practice physical barrier contraception from study entry to 6 months after the last day of treatment

Exclusion Criteria:

  • Have peripheral neuropathy of Grade 3 or Grade 4 at screening
  • Have peripheral sensory neuropathy of Grade 2 or greater at screening
  • Have an interval from previous neurotoxic drugs less than 3 months unless reasonably recovered from all grades of neurotoxicity to grade 1 or lower as judged by the investigator
  • Have known hypersensitivity to chemotherapeutic agents
  • Have chronic diarrhea
  • Have a history of thrombocytopenia with complications including hemorrhage or bleeding > Grade 2 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe
  • Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia
  • Received investigational agents or systemic anticancer agents (other than neurotoxic compounds) within 5 half lives or 28 days, whichever is shorter, prior to Day 1 of treatment
  • Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions
  • Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia requiring medical therapy
  • Have other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study
  • Is pregnant or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04808453

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Contact: Ze-Qi Xu, Ph.D (630)415-5601

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United States, Arizona
Honor Health Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Patricia Shannon    480-323-1350   
Principal Investigator: Erkut Borazanci, MD         
United States, Florida
Florida Cancer Specialists Recruiting
Lake Mary, Florida, United States, 32746
Contact: Jessica Keville   
Principal Investigator: Shekeab Jauhari, MD         
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Ashley Campbell    216-844-6088   
Principal Investigator: Afshin Dowlati, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Eris Steele    615-329-7305   
Principal Investigator: Howard Burris, MD         
Sponsors and Collaborators
Coordination Pharmaceuticals, Inc.
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Responsible Party: Coordination Pharmaceuticals, Inc. Identifier: NCT04808453    
Other Study ID Numbers: CPI-300CL21-01
First Posted: March 22, 2021    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Coordination Pharmaceuticals, Inc.:
Intravenous Infusion