Study of CPI-200 in Patients With Advanced Tumors

  • STATUS
    Recruiting
  • End date
    Jun 24, 2021
  • participants needed
    27
  • sponsor
    Coordination Pharmaceuticals, Inc.
Updated on 23 July 2020
renal function
metastasis

Summary

This is a prospective, open-label, single arm, non-randomized study of CPI-200 in patients with advanced tumors. CPI-200 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)

Description

Primary Objectives:

To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-200 in patients with advanced tumors

Secondary Objectives:

  • To evaluate the pharmacokinetics (PK) of CPI-200
  • To evaluate clinical response and resolution of symptoms after CPI-200 treatment
  • To characterize adverse events of CPI-200 in patients with advanced cancers

Up to 7 dose levels of CPI-200 will be tested using an accelerated titration method followed by a conventional 3 + 3 dose escalation study design. 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-200 within 21 days:

  • All Grade 4 or greater adverse events as determined by CTCAEv5 criteria, excluding toxicities clearly related to disease progression or inter-current illness
  • Any Grade 3 or greater non-hematologic, non-dermatologic toxicity with the exception of Grade 3 nausea, vomiting or diarrhea if lasting less than 72 hours, alopecia, or Grade 3 fatigue if lasting less than 7 days as determined by CTCAEv5 criteria
  • Grade 3 thrombocytopenia in the presence of bleeding
  • Grade 3 or greater febrile neutropenia
  • Any hematologic or non-hematologic adverse events or abnormal laboratory value(s) related to CPI-200 that result(s) in permanent study discontinuation of study treatment

Details
Treatment CPI-200
Clinical Study IdentifierNCT03953742
SponsorCoordination Pharmaceuticals, Inc.
Last Modified on23 July 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Advanced Solid Tumor?
Age >18 years
Males and females
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 a life expectancy of at least 12 weeks (in the opinion of the investigator)
Have adequate bone marrow reserve, liver and renal function
Be reasonably recovered from preceding major surgery and 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 3 months after the last day of treatment

Exclusion Criteria

Have peripheral sensory neuropathy of Grade 2 or greater at screening
Have known hypersensitivity to chemotherapeutic agents
Have 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: unstable angina, myocardial infarction or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%
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
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