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Study of CPI-200 in Patients With Advanced Tumors

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ClinicalTrials.gov Identifier: NCT03953742
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Coordination Pharmaceuticals, Inc.

Brief 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)

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: CPI-200 Phase 1

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Accelerated titration method followed by a conventional 3 + 3 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-200 Via Intravenous Infusion in Patients With Advanced Solid Tumors
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 24, 2020
Estimated Study Completion Date : June 24, 2021

Arm Intervention/treatment
Experimental: CPI-200

Dose Escalation Group: CPI-200 will be administered via intravenous infusion once every 3 weeks for up to 7 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design

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

Drug: CPI-200
CPI-200 will be administered via intravenous infusion on Day 1 of a 21-Day cycle




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: 21 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 CTCAE


Secondary Outcome Measures :
  1. Rate of 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 (%) of participants

  2. Rate of 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, which will be reported as % of participants

  3. Maximum Plasma Concentration (Cmax) [ Time Frame: 8 Days ]
    • To evaluate maximum plasma concentration (Cmax) of CPI-200 in patients tested

  4. Area Under the Curve (AUC) [ Time Frame: 8 Days ]
    • To evaluate area under the curve (AUC) of CPI-200 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
Criteria

Inclusion Criteria:

  • 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

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): NCT03953742


Contacts
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Contact: Ze-Qi Xu, Ph.D. 630-415-5601 zq@coordinationpharma.com

Locations
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United States, Michigan
South Texas Accelerated Research Therapeutics (START Midwest) Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Katie Robinson, BSN, RN, OCN, CMSRN    616-389-1739    katie.robinson@startmidwest.com   
Principal Investigator: Manish R Sharma, M.D.         
Sponsors and Collaborators
Coordination Pharmaceuticals, Inc.

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Responsible Party: Coordination Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03953742     History of Changes
Other Study ID Numbers: CPI-200CL01
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: May 2019
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
Phase 1
CPI-200