Study of CPI-100 in Patients With Advanced Tumors

Advanced Tumors Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03781362
• Other study ID #: CPI-CL18-001
• Status: Completed
• Phase: Phase 1
• Start date: December 21, 2018
• Est. completion date: June 21, 2022

Study information

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

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 21, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Tumors

Intervention

Drug:
• CPI-100
CPI-100 will be administered via intravenous infusion on Day 1 of a 14-Day cycle
• Capecitabine
Capecitabine will be administered 1000 mg/m2 orally twice a day for 2 weeks followed by a 7-day rest period

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	South Texas Accelerated Research Therapeutics	Grand Rapids	Michigan
United States	South Texas Accelerated Research Therapeutics	San Antonio	Texas

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 CTCAE5	28 Days
Secondary	Clinical Benefit	• To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%)	through study completion, an average of 4 months
Secondary	Adverse Effect	• To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE	through study completion, an average of 4 months
Secondary	Maximum Plasma Concentration (Cmax)	• To evaluate maximum plasma concentration (Cmax) of CPI-100 in patients tested	8 Days
Secondary	Area Under the Curve (AUC)	• To evaluate area under the curve (AUC) of CPI-100 in patients tested	8 Days