Study of CPI-200 in Patients With Advanced Tumors

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953742
• Other study ID #: CPI-200CL01
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2019
• Est. completion date: February 15, 2022

Study information

• Verified date: February 2022
• Source: Coordination Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 15, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor

Intervention

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

Locations

Country	Name	City	State
United States	South Texas Accelerated Research Therapeutics (START Midwest)	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Coordination Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD)	• 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	21 days
Secondary	Rate of Clinical Benefit	• To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%) of participants	through study completion, an average of 4 months
Secondary	Rate of Adverse Effect	• To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE, which will be reported as % of participants	through study completion, an average of 4 months
Secondary	Maximum Plasma Concentration (Cmax)	• To evaluate maximum plasma concentration (Cmax) of CPI-200 in patients tested	8 Days
Secondary	Area Under the Curve (AUC)	• To evaluate area under the curve (AUC) of CPI-200 in patients tested	8 Days