Advanced Solid TumorPhase 1NCT03953742
Study of CPI-200 in Patients With Advanced Tumors
A Phase 1 study testing CPI-200 in people with Advanced Solid Tumor, run by Coordination Pharmaceuticals, Inc. at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- CPI-200
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 15 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
South Texas Accelerated Research Therapeutics (START Midwest)
Grand Rapids, Michigan, 49546
About this study
Official title: A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-200 Via Intravenous Infusion in Patients With Advanced Solid Tumors
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)
Read the detailed description
Primary Objectives:
- To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-200 in patients with advanced tumors
Secondary Objectives:
- To evaluate the pharmacokinetics (PK) of CPI-200
- To evaluate clinical response and resolution of symptoms after CPI-200 treatment
- To characterize adverse events of CPI-200 in patients with advanced cancers
Up to 7 dose levels of CPI-200 will be tested using an accelerated titration method followed by a conventional 3 + 3 dose escalation study design. 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-200 within 21 days:
- All Grade 4 or greater adverse events as determined by CTCAEv5 criteria, excluding toxicities clearly related to disease progression or inter-current illness
- Any Grade 3 or greater non-hematologic, non-dermatologic toxicity with the exception of Grade 3 nausea, vomiting or diarrhea if lasting less than 72 hours, alopecia, or Grade 3 fatigue if lasting less than 7 days as determined by CTCAEv5 criteria
- Grade 3 thrombocytopenia in the presence of bleeding
- Grade 3 or greater febrile neutropenia
- Any hematologic or non-hematologic adverse events or abnormal laboratory value(s) related to CPI-200 that result(s) in permanent study discontinuation of study treatment
- Conditions
- Advanced Solid Tumor
- Being tested
- CPI-200
- Keywords
- Intravenous infusion, Phase 1, CPI-200
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI-200Drug
CPI-200 will be administered via intravenous infusion on Day 1 of a 21-Day cycle
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: CPI-200 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days
Secondary outcomes (4)
Rate of Clinical Benefit
- To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%) of participants
Measured: through study completion, an average of 4 months
Rate of Adverse Effect
- To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE, which will be reported as % of participants
Measured: through study completion, an average of 4 months
Maximum Plasma Concentration (Cmax)
- To evaluate maximum plasma concentration (Cmax) of CPI-200 in patients tested
Measured: 8 Days
Area Under the Curve (AUC)
- To evaluate area under the curve (AUC) of CPI-200 in patients tested
Measured: 8 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start1 Jul 2019
- Primary completion1 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Accelerated titration method followed by a conventional 3 + 3 study design
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordination Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953742
- Sponsor's protocol ID
- CPI-200CL01
- Status last verified
- Feb 2022
- First submitted
- 15 May 2019
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared due to confidentiality agreements.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of CPI-200 Via Intravenous Infusion in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03953742
- Acronym / sponsor ID
- CPI-200CL01
- Conditions
- Advanced Solid Tumor
- Keywords
- Intravenous infusion, Phase 1, CPI-200
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Coordination Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
Primary Objectives:
- To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-200 in patients with advanced tumors
Secondary Objectives:
- To evaluate the pharmacokinetics (PK) of CPI-200
- To evaluate clinical response and resolution of symptoms after CPI-200 treatment
- To characterize adverse events of CPI-200 in patients with advanced cancers
Up to 7 dose levels of CPI-200 will be tested using an accelerated titration method followed by a conventional 3 + 3 dose escalation study design. 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-200 within 21 days:
- All Grade 4 or greater adverse events as determined by CTCAEv5 criteria, excluding toxicities clearly related to disease progression or inter-current illness
- Any Grade 3 or greater non-hematologic, non-dermatologic toxicity with the exception of Grade 3 nausea, vomiting or diarrhea if lasting less than 72 hours, alopecia, or Grade 3 fatigue if lasting less than 7 days as determined by CTCAEv5 criteria
- Grade 3 thrombocytopenia in the presence of bleeding
- Grade 3 or greater febrile neutropenia
- Any hematologic or non-hematologic adverse events or abnormal laboratory value(s) related to CPI-200 that result(s) in permanent study discontinuation of study treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Accelerated titration method followed by a conventional 3 + 3 study design
| Arm | Type | Receives |
|---|---|---|
| CPI-200 | Experimental | Drug: CPI-200Dose 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPI-200CPI-200 will be administered via intravenous infusion on Day 1 of a 21-Day cycle | Drug | CPI-200 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 21 days
• 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
4 secondary outcomes
Rate of Clinical Benefit
Time frame: through study completion, an average of 4 months
Rate of Adverse Effect
Time frame: through study completion, an average of 4 months
Maximum Plasma Concentration (Cmax)
Time frame: 8 Days
Area Under the Curve (AUC)
Time frame: 8 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: No. The data will not be shared due to confidentiality agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPI-200 in people with Advanced Solid Tumor, run by Coordination Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022; AzTrials last refreshed its copy on 7 Nov 2026.