Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478862
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-17
Brief Title:
Promitil Treatment of Patients With Solid Tumors Associated With Deleterious Mutations Who Have Progressed After Therapy
Sponsor:
Lipomedix Pharmaceuticals Inc
Organization:
Lipomedix Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 2A Multicenter Open Label Study of Promitil for the Treatment of Patients With Solid Tumors Associated With Deleterious Mutations Who Have Progressed After First Line Therapy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This multicenter Phase 2a study was designed to evaluate the safety tolerability and efficacy of Promitil in patients with recurrent ovarian cancer and inoperable locally advanced or metastatic pancreatic cancer which bears deleterious germline or somatic mutations in BRCA1 BRCA2 or HRD homologous recombination deficiency -related genes
Based on reported preclinical and clinical efficacy of Mitomycin C in BRCA-mutated tumors and together with the demonstrated improved safety profile of Promitil in humans it is expected that this liposomal formulation will have a favorable therapeutic index and significant clinical antitumor activity in patients with tumors bearing BRCA 12 andor PALB2 mutations
Based on reported preclinical and clinical efficacy of Mitomycin C in BRCA-mutated tumors and together with the demonstrated improved safety profile of Promitil in humans it is expected that this liposomal formulation will have a favorable therapeutic index and significant clinical antitumor activity in patients with tumors bearing BRCA 12 andor PALB2 mutations
Detailed Description:
The study will include a Screening Treatment Phase and Long-Term Follow-up LTFU Phase Upon signing the informed consent form all subjects will undergo screening procedures to assess eligibility within 21 days prior to receiving study drug Eligible subjects will be intravenously IV administered 20 mgkg Promitil on Day 1 of each 28-day cycle for up to 6 cycles Subjects who complete the 6-cycle Treatment Phase have the option to continue to receive Promitil until disease progression death unacceptable toxicity or withdrawal of consent During the 6-month Treatment Phase safety assessments will be conducted at each study visit Days 1 2 7 and 14 of Cycle 1 Day 1 of Cycle 2 and Cycles 4 and beyond and Days 1 2 and 7 of Cycle 3 Safety will be assessed by measurement of weight physical examinations vital signs ECG recordings blood chemistry hematologic and urinalysis parameters and review of Adverse and Serious Adverse events SAEs and concomitant medications Response will be assessed by CTMRIPET-CT scans and biomarker levels with imaging conducted every 8 weeks every 2 treatment cyclesFor patients who stopped receiving Promitil for any reason other than disease progression response will continue to be assessed every 12 weeks until disease progression death or withdrawal of consent but no later than 1 year from first dose of Promitil Once study treatment ends all subjects will be followed up long-term with survival status assessed every 3 months for up to 1 year or until death the earlier of the two
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None