Study of CPI-100 in Patients With Advanced Tumors

NCT03781362 | Completed Phase 1 FDA Drug

• 1 other identifier: CPI-CL18-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Advanced Tumors

Keywords

Intravenous infusion

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 CTCAE5

  28 Days

Secondary Outcomes (4)

• Clinical Benefit

  through study completion, an average of 4 months

• 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 (2)

CPI-100 Monotherapy

EXPERIMENTAL

Dose Escalation Groups: CPI-100 will be administered via intravenous infusion once every 2 weeks (Q2W) for up to 5 dose levels and once every 3 weeks (Q3W Arm A) for up to 4 dose levels in a 3 + 3 dose escalation study Dose Expansion Group: Maximum tolerated dose or the recommended Phase 2 dose (RP2D) from dose escalation group

Drug: CPI-100

CPI-100 Combination with Capecitabine

EXPERIMENTAL

CPI-100 will be administered via intravenous infusion once every 3 weeks in combination with oral capecitabine for up to 4 dose levels in a dose escalation study (Q3W Arm B)

Drug: CPI-100; Drug: Capecitabine

Interventions

CPI-100 DRUG

CPI-100 will be administered via intravenous infusion on Day 1 of a 14-Day cycle

CPI-100 Combination with Capecitabine; CPI-100 Monotherapy

Capecitabine DRUG

Capecitabine will be administered 1000 mg/m2 orally twice a day for 2 weeks followed by a 7-day rest period

CPI-100 Combination with Capecitabine

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordination Pharmaceuticals, Inc.: lead

Study Sites (3)

South Texas Accelerated Research Therapeutics

Grand Rapids, Michigan, 49546, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

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

Model Details: 3 + 3 dose escalation study design

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: December 21, 2018
• Primary Completion: June 21, 2022
• Study Completion: June 21, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)