Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04608045|
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : October 30, 2020
The expansion study is a Phase I, multicenter, open label feasibility trial to characterize the pharmacologic activity of IV CPX-POM in bladder tumor tissues obtained from patients with MIBC (Stage ≥T2, N0-N1, M0) who will be scheduled for RC with bilateral (standard or extended) pelvic lymph node dissection (PLND).
The Dose Escalation study was a Phase I, multicenter, open label, dose escalation study to evaluate the DLTs and MTD and to determine the recommended Phase 2 dose (RP2D) of CPX-POM administered IV in patients with any histologically- or cytologically-confirmed solid tumor type and was completed.
|Condition or disease||Intervention/treatment||Phase|
|Advanced Solid Tumor||Drug: CPX-POM||Phase 1|
The expansion cohort of this study will be conducted at up to 3 study sites. It will be an open-label feasibility trial to characterize the pharmacologic activity of IV CPX-POM in bladder tumor tissues obtained from patients with MIBC (Stage ≥T2, N0-N1,M0) who will be scheduled for RC with bilateral (standard or extended) pelvic lymph node dissection (PLND). Approximately half of the patients enrolled will be cisplatin eligible and half will be chemotherapy eligible and scheduled to receive neoadjuvant chemotherapy with gemcitabine + cisplatin. Neoadjuvant treatment with CPX-POM, whether alone or in combination with gemcitabine +cisplatin, will start within 8 weeks of transurethral resection of the bladder tumor (TURBT) that showed muscularis propria invasion.
Approximately 12 patients will be enrolled. Patients who are cisplatin eligible will be treated with two 21-day treatment cycles of CPX-POM (Cycle 1, Days 1-5 treatment, rest days 6-21; Cycle 2, Days 22-26 treatment, rest days 27-43) before a planned RC. Chemotherapy-eligible patients who are scheduled to receive neoadjuvant chemotherapy (gemcitabine + cisplatin in three 21-day treatment cycles) will be treated in addition with three 21-day treatment cycles of CPX-POM (Cycle 1, Days 1-5 treatment, rest days 6-21; Cycle 2, Days 22-26 treatment, rest days 27-42; Cycle 3, Days 43-47, rest days 48-63), i.e. concurrently with the prescribed chemotherapy. The cisplatin + gemcitabine dosing regimen for chemotherapy-eligible patients in the Expansion Cohort will be administered per the institution's standard of care. After each infusion of CPX-POM, patients will remain in the clinic for at least a 1-hour observation period. On Day 1 of Cycle 1, single blood and clean catch urine samples will be collected prior to the first CPX-POM infusion.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1, First-in-Human, Safety, Dose Tolerance, Pharmacokinetics, and Pharmacodynamics Study of CPX-POM in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
|Experimental: CPX-POM, 900 mg/m2 by 20 minute IV infusion||
- determine disease response following 2 or 3 CPX-POM treatment cycles by assessing the complete and partial pathologic response rate at the time of radical cystectomy (RC) [ Time Frame: 56 days ]Tumors will be assessed in a standard manner and given grade/stage according to the American Joint Commission on Cancer (AJCC) criteria. Efficacy will be assessed based on pathologic criteria and evidence of pharmacologic activity in the target tissue.
- Number of Participant with any Serious Adverse Events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE version 4.03) [ Time Frame: 56 days ]Incidence of Serious Adverse Events in subjects receiving CPX-POM.
- Number of Participant with any Adverse Events (AEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE version 4.03) [ Time Frame: 56 days ]Incidence of Adverse Events in subjects receiving CPX-POM.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04608045
|United States, Kansas|
|University of Kansas Medical Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Christina M Hopkins 913-588-2566 firstname.lastname@example.org|
|Principal Investigator: John A Taylor III, MD, MSc|
|Principal Investigator:||John A Taylor III, MD, MSc||University of Kansas Medical Center|