Promitil Treatment of Patients With Solid Tumors Associated With Deleterious Mutations Who Have P… (NCT06478862) | Clinical Trial Compass
TerminatedPhase 2
Promitil Treatment of Patients With Solid Tumors Associated With Deleterious Mutations Who Have Progressed After Therapy
Stopped: Sponsor decision
Israel19 participantsStarted 2024-06-13
Plain-language 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 1/2 and/or PALB2 mutations.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 18 years of age or older on day of consent
. Patient with either one of the following histologically or cytologically confirmed, deemed incurable malignancies:
. Recurrent ovarian cancer
. Inoperable, locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
. Patient with PDAC measurable by RECIST 1.1. Previously irradiated lesions may be considered measurable if there has been demonstrated progression in these lesions. Ovarian cancer patients can have either measurable or non-measurable lesions (i.e., ovarian cancer patients with mostly ascites or pleural effusion are eligible)
. Tumor with a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2 or HRD-related genes as determined by a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited laboratory. Note: Patients with positive HRD score can be eligible regardless of any evidence for germline or somatic mutations
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patient received at least 1 line of chemotherapy for advanced pancreatic adenocarcinoma or ovarian cancer. Prior neoadjuvant and adjuvant chemotherapy are allowed, and platinum re-challenge is allowed for ovarian cancer patients for whom it is felt to be in their best interests, as determined by the Investigator. Prior PARP inhibitor, hormonal, biological, or immunological therapy are allowed. Palliative radiation therapy is allowed, provided it was/will be completed ≥2 weeks prior starting trial therapy
. Capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
Exclusion criteria
. Uncontrolled intercurrent illness including, but not limited to, severe or ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmias, or psychiatric illness/social situations that would limit compliance with study requirements
. Any other severe concurrent disease which, in the judgment of the investigator, would make the subject unsuited for treatment
. History of chronic active hepatitis, including carriage of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless patient is adequately treated and shown to be serum virus-free
. Evidence of active bleeding
. Untreated brain metastases Note: Patients with brain metastases treated by surgery or radiation who are stable and symptom-free (≤ 4 mg dexamethasone/day) are eligible to participate in the study
. Patient is pregnant or lactating
. Prior intravenous treatment with MMC, either alone or in combination
. Other anti-cancer treatment within 2 weeks before start of study drug