Description:
This is a prospective, open-label, single arm, non-randomized study of CPI-300 in patients
with advanced tumors. CPI-300 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).
Title
- Brief Title: Phase I Study of CPI-300 in Patients With Advanced Tumors
- Official Title: A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-300 Via Intravenous Infusion in Patients With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
CPI-300CL21-01
- NCT ID:
NCT04808453
Conditions
Interventions
Drug | Synonyms | Arms |
---|
CPI-300 | | CPI-300 |
Purpose
This is a prospective, open-label, single arm, non-randomized study of CPI-300 in patients
with advanced tumors. CPI-300 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
Up to 6 dose levels of CPI-300 will be tested. 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-300 within 28 days:
- 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)
Blood samples will be drawn to determine drug blood concentrations for pharmacokinetic
assessment.
Trial Arms
Name | Type | Description | Interventions |
---|
CPI-300 | Experimental | Dose Escalation Group: CPI-300 will be administered via intravenous infusion once every 2 weeks for up to 6 dose levels using an accelerated titration method followed by a conventional 3 + 3 study design | |
Eligibility Criteria
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
- Have an ECOG performance status of 0-1
- Have adequate bone marrow reserve, liver and renal function
- 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 chronic diarrhea
- 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
- 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:
angina pectoris, coronary artery disease or cerebrovascular accident, transient
ischemic attack, cardiac failure with known ejection fraction less than 40%, or
cardiac arrhythmia requiring medical therapy
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Safety |
Time Frame: | 28 days |
Safety Issue: | |
Description: | To determine the maximum tolerated dose (MTD), which is defined as the highest dose level at which number of patients reporting a dose limiting toxicity (DLT) is less than or equal to 33% |
Secondary Outcome Measures
Measure: | Clinical Benefit |
Time Frame: | 28 Days and additional CPI-300 treatments till disease progression or intolerability |
Safety Issue: | |
Description: | To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%) |
Measure: | Adverse Effect |
Time Frame: | 28 Days and additional CPI-300 treatment till disease progression or intolerability |
Safety Issue: | |
Description: | To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE |
Measure: | Maximum Plasma Concentration (Cmax) |
Time Frame: | 8 Days |
Safety Issue: | |
Description: | To evaluate maximum plasma concentration (Cmax) of CPI-300 in patients tested |
Measure: | Area Under the Curve (AUC) |
Time Frame: | 8 Days |
Safety Issue: | |
Description: | To evaluate area under the curve (AUC) of CPI-300 in patients tested |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Coordination Pharmaceuticals, Inc. |
Trial Keywords
Last Updated
August 2, 2021