Description:
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).
Title
- Brief Title: Study of CPI-100 in Patients With Advanced Tumors
- 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 IDs
- ORG STUDY ID:
CPI-CL18-001
- NCT ID:
NCT03781362
Conditions
Interventions
Drug | Synonyms | Arms |
---|
CPI-100 | | CPI-100 Combination with Capecitabine |
Capecitabine | | CPI-100 Combination with Capecitabine |
Purpose
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).
Detailed 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)
Trial Arms
Name | Type | Description | Interventions |
---|
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 | |
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) | |
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
- 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Maximum Tolerated Dose (MTD) |
Time Frame: | 28 Days |
Safety Issue: | |
Description: | • 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 |
Secondary Outcome Measures
Measure: | Clinical Benefit |
Time Frame: | through study completion, an average of 4 months |
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: | through study completion, an average of 4 months |
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-100 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-100 in patients tested |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Coordination Pharmaceuticals, Inc. |
Trial Keywords
Last Updated
August 4, 2021