Study of CPI-200 in Patients With Advanced Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumor
• Interventions: Drug: CPI-200

• Registration Number: NCT03953742
• Lead Sponsor: 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)

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

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-17
• Study Start: 2019-07-01
• Status Verified: 2022-02
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-15
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CPI-200	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

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD)	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

Name	Time	Method
Maximum Plasma Concentration (Cmax)	8 Days	• To evaluate maximum plasma concentration (Cmax) of CPI-200 in patients tested
Rate of Adverse Effect	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
Area Under the Curve (AUC)	8 Days	• To evaluate area under the curve (AUC) of CPI-200 in patients tested
Rate of Clinical Benefit	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

Trial Locations

Locations (1)

South Texas Accelerated Research Therapeutics (START Midwest); 🇺🇸 Grand Rapids, Michigan, United States