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Trial record 1 of 1 for:    NCT03781362
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Study of CPI-100 in Patients With Advanced Tumors

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ClinicalTrials.gov Identifier: NCT03781362
Recruitment Status : Completed
First Posted : December 19, 2018
Last Update Posted : July 20, 2022
Information provided by (Responsible Party):
Coordination Pharmaceuticals, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Advanced Tumors Drug: CPI-100 Drug: Capecitabine Phase 1

Detailed 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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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-100 Via Intravenous Infusion in Patients With Advanced Solid Tumors
Actual Study Start Date : December 21, 2018
Actual Primary Completion Date : June 21, 2022
Actual Study Completion Date : June 21, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: CPI-100 Monotherapy

Dose Escalation Groups:

CPI-100 will be administered via intravenous infusion once every 2 weeks (Q2W) for up to 5 dose levels and once every 3 weeks (Q3W Arm A) for up to 4 dose levels in a 3 + 3 dose escalation study

Dose Expansion Group: Maximum tolerated dose or the recommended Phase 2 dose (RP2D) from dose escalation group

Drug: CPI-100
CPI-100 will be administered via intravenous infusion on Day 1 of a 14-Day cycle

Experimental: CPI-100 Combination with Capecitabine
CPI-100 will be administered via intravenous infusion once every 3 weeks in combination with oral capecitabine for up to 4 dose levels in a dose escalation study (Q3W Arm B)
Drug: CPI-100
CPI-100 will be administered via intravenous infusion on Day 1 of a 14-Day cycle

Drug: Capecitabine
Capecitabine will be administered 1000 mg/m2 orally twice a day for 2 weeks followed by a 7-day rest period

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 28 Days ]
    • To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy as assessed by CTCAE5

Secondary Outcome Measures :
  1. Clinical Benefit [ Time Frame: through study completion, an average of 4 months ]
    • To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%)

  2. Adverse Effect [ Time Frame: through study completion, an average of 4 months ]
    • 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-100 in patients tested

  4. Area Under the Curve (AUC) [ Time Frame: 8 Days ]
    • To evaluate area under the curve (AUC) of CPI-100 in patients tested

Information from the National Library of Medicine

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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
  • 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

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 ClinicalTrials.gov identifier (NCT number): NCT03781362

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United States, Michigan
South Texas Accelerated Research Therapeutics
Grand Rapids, Michigan, United States, 49546
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Texas
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Coordination Pharmaceuticals, Inc.
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Responsible Party: Coordination Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03781362    
Other Study ID Numbers: CPI-CL18-001
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will not be shared due to confidentiality agreements

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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
Additional relevant MeSH terms:
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Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents