Study of CPI-100 in Patients With Advanced Tumors

  • STATUS
    Recruiting
  • days left to enroll
    16
  • participants needed
    42
  • sponsor
    Coordination Pharmaceuticals, Inc.
Updated on 15 August 2021

Summary

This is a prospective, open-label, 2-arm, non-randomized study of CPI-100 in patients with advanced tumors. CPI-100 is administered via intravenous infusion in a 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-100 as once every two weeks (Q2W) and once every three weeks (Q3W) regimens in patients with advanced tumors

Secondary Objectives:

  • To evaluate the pharmacokinetics (PK) of CPI-100
  • To evaluate clinical response and resolution of symptoms after CPI-100 treatment
  • To characterize adverse events of CPI-100 monotherapy and CPI-100 in combination with capecitabine in patients with advanced cancers

Up to 5 dose levels of CPI-100 Q2W, 4 dose levels of Q3W regimen of CPI-100 monotherapy (Q3W Arm A) and 4 dose levels of Q3W regimen of CPI-100 in combination with capecitabine (Q3W Arm B) will be tested in a dose escalation study. 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-100 within 28 days (Q2W) or 42 days (Q3W):

  • 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)

Details
Condition Advanced Tumors
Treatment Capecitabine, CPI-100
Clinical Study IdentifierNCT03781362
SponsorCoordination Pharmaceuticals, Inc.
Last Modified on15 August 2021

Eligibility

Yes No Not Sure

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
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 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
Is pregnant or breast-feeding
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