Study of CPI-200 in Patients With Advanced Tumors

NCT03953742 | Completed Phase 1 FDA Drug

• 1 other identifier: CPI-200CL01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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)

Conditions

Advanced Solid Tumor

Keywords

Intravenous infusion; Phase 1; CPI-200

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Rate of Clinical Benefit

  through study completion, an average of 4 months

• Rate of Adverse Effect

  through study completion, an average of 4 months

• Maximum Plasma Concentration (Cmax)

  8 Days

• Area Under the Curve (AUC)

  8 Days

Study Arms (1)

CPI-200

EXPERIMENTAL

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

Interventions

CPI-200 DRUG

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

CPI-200

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordination Pharmaceuticals, Inc.: lead

Study Sites (1)

South Texas Accelerated Research Therapeutics (START Midwest)

Grand Rapids, Michigan, 49546, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Accelerated titration method followed by a conventional 3 + 3 study design

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 17, 2019
• Study Start: July 1, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 15, 2022
• Last Updated: February 24, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)