Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: PharmaMar
Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers
Disqualifiers: Uncontrolled hypertension, Active infection, HIV, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called PM54 to see if it is safe and effective in shrinking tumors and keeping them stable for several months in patients with advanced cancer.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop all current medications, but there are specific washout periods for certain treatments. You must stop chemotherapy at least three weeks before, monoclonal antibody therapy four weeks before, and other biological therapies two weeks before starting the trial. Hormonal therapies for hormone-sensitive breast cancer must be stopped at least one week before, except for certain exceptions.
What data supports the effectiveness of the drug PM54 for solid tumors?
The research suggests that chemotherapy, which is often used in combination with other treatments, can improve survival and quality of life in patients with advanced solid tumors. Additionally, immune checkpoint inhibitors, a type of drug used for solid tumors, have shown effectiveness even in patients with poor health status, indicating potential benefits for treatments like PM54.
12345What makes the drug PM54 unique for treating solid tumors?
The drug PM54 is unique because it may represent a novel approach to treating solid tumors, potentially involving mechanisms like immune checkpoint inhibition, which has shown promise in other cancers by helping the immune system better recognize and attack cancer cells.
678910Eligibility Criteria
This trial is for adults over 18 with advanced solid tumors, including specific cancers of the urinary tract, skin (melanoma), gastrointestinal system, lung, gynecological organs, breast and certain sarcomas. Participants must be in fairly good health otherwise (ECOG ≤1).Inclusion Criteria
I have an advanced solid tumor with no standard treatment options.
Voluntarily signed and dated written informed consent obtained prior to any specific study procedure
I am 18 years old or older.
+7 more
Exclusion Criteria
I do not have major illnesses or conditions that would interfere with the treatment.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Phase Ia - Dose Escalation
Evaluate the safety, tolerability, and identify dose-limiting toxicities (DLTs) of PM54
3 weeks
Cycle 1 is 21 days
Phase Ib - Expansion
Evaluate the antitumor activity of PM54 in terms of clinical benefit and response
Up to 36 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 36 months
Participant Groups
PM54's safety and maximum tolerated dose are being tested first. Then its effectiveness against tumor growth will be assessed using imaging criteria (RECIST v.1.1) or serum markers in patients with selected advanced solid tumors.
1Treatment groups
Experimental Treatment
Group I: PM54Experimental Treatment1 Intervention
Phase Ia (dose escalation) stage: Patients will receive PM54 i.v. at a starting dose of 0.3 mg/m2.
Phase Ib (expansion) stage: Patients will receive PM54 i.v. at the RD determined during the Phase Ia stage.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
South Texas Accelerated Research TherapeuticsSan Antonio, TX
Loading ...
Who Is Running the Clinical Trial?
PharmaMarLead Sponsor
References
Cytotoxic chemotherapy in advanced non-small cell lung cancer: a review of standard treatment paradigms. [2015]A 1995 meta-analysis of nine trials involving 1190 patients by the Non-Small Cell Lung Cancer Collaborative Group reported that in advanced metastatic disease, platinum-based chemotherapy provides a survival benefit compared with best supportive care. Since then, several randomized trials using either platinum-based combination regimens or selected new single agents have confirmed this observation of a modest survival advantage, as well as improved quality of life. New agents such as paclitaxel, docetaxel, vinorelbine, gemcitabine, and irinotecan have shown significant single-agent activity in advanced non-small cell lung cancer. Two recent meta-analyses have suggested that regimens including these newer agents offer modest improvement in outcomes compared with older regimens. Several randomized trials have evaluated these modern platinum-based doublets and suggested that no one combination is superior when using survival as the primary measure of outcome. Future research may improve outcomes through identifying prognostic markers of treatment response to both standard cytotoxic and newer "targeted" therapies.
Outcomes to first-line pembrolizumab in patients with non-small-cell lung cancer and very high PD-L1 expression. [2023]In non-small-cell lung cancers with programmed death-ligand 1 (PD-L1) expression on ≥50% of tumor cells, first-line treatment with the PD-1 inhibitor pembrolizumab improves survival compared with platinum-doublet chemotherapy. Whether higher PD-L1 levels within the expression range of 50%-100% predict for even greater benefit to pembrolizumab is currently unknown.
High neutrophil-to-lymphocyte ratio persistent during first-line chemotherapy predicts poor clinical outcome in patients with advanced urothelial cancer. [2022]Increased neutrophil-to-lymphocyte ratio (NLR), an index of systemic inflammation, is associated with poor outcome for various types of cancers. We assessed the role on outcome prediction of NLR at baseline and persistent during first-line chemotherapy in patients with advanced urothelial cancer.
Role of chemotherapy in patients with poor performance status and advanced non-small cell lung cancer. [2019]The treatment of advanced non-small cell lung cancer remains an important area of research, with many questions about the use of chemotherapy still unanswered. It is now recognized that chemotherapy improves survival and alleviates disease-related symptoms in the population with advanced non-small cell lung cancer. However, it is unknown whether these benefits apply to patients with poor performance status (PS). These patients (Eastern Cooperative Oncology Group PS2) have inferior outcomes compared with more fit patients, and historically, they have been excluded from clinical trials. In other trials with broader eligibility, PS2 patients comprised fewer than 20% of the study populations. These factors have led to difficulty in ascertaining true outcomes in the PS2 patient population. However, the PS2 population accounts for a significant portion (up to 30% to 40%) of patients in oncology practice, and emerging data suggest that these patients may in fact garner benefits, such as prolonged survival and improved quality of life, from chemotherapy. Studies with single-agent vinorelbine or paclitaxel have shown improved survival with chemotherapy versus supportive care that remain significant when stratified by PS. A recent subset analysis of PS2 patients enrolled in a trial comparing carboplatin and paclitaxel with single-agent paclitaxel suggests that combination chemotherapy is a feasible option and is potentially preferable to single-agent therapy. Importantly, several analyses have shown that toxicity is not necessarily worse in this population compared with more fit patients. Because optimal agents or combinations have not been defined, novel strategies and therapeutics are urgently needed in this population.
Immune checkpoint inhibitors in patients with solid tumors and poor performance status: A prospective data from the real-world settings. [2023]Immune checkpoint inhibitors (ICIs) are rapidly being incorporated as treatment option either alone or in combination with chemotherapy in most of the solid tumors. Since there is very limited data of ICI in patients with poor performance status (PS) from the real world settings, we performed a retrospective audit of patients who received ICI and report the analysis based on ECOG PS of these patients.This study is a retrospective audit of a prospectively collected database of patients receiving ICIs for advanced solid tumors in any line between August 2015 and November 2018 at Tata Memorial Hospital, Mumbai, India. All statistical calculations were performed using SPSS statistical software for windows version 20.0.A total of 155 patients who received ICIs during the specified period were evaluated for this study. Baseline ECOG PS 0-1 (n = 103, 66.4%) patients was associated with median OS 9.1 (95% CI [confidence interval], 4.4-NR) months when compared to ECOG 2-4 (n = 52, 33.5%) which had a median OS of 2.9 (95% CI; 1.8-5.5) months (HR, 1.7, 95% CI, 1.1-2.7, log rank P = .017). The disease control rate for the poor PS group was 34.6%. However, 27.3% patients (95% CI: 20.3-34.3) were still alive at 1 year. Median OS in patients with PS 2 was 3.7 months (95% CI: 0-11.6) as compared to 1.8 months (95% CI: 0.2-3.4) for those with PS 3-4 (HR-2.0; 95% CI: 1.0-3.9, P = .041). The tolerance to ICIs was good with no grade 3/4 toxicities in 44 (84.6%) patients.Immune checkpoint inhibitors are a safe and effective therapeutic option even in solid tumor patients with poor performance status.
The emerging use of immune checkpoint blockade in the adjuvant setting for solid tumors: a review. [2020]The use of immune checkpoint inhibitors has been approved in the advanced and metastatic setting for many types of solid tumors. Nonetheless, their role in the adjuvant setting is limited to the treatment of surgically resected melanoma. Ipilimumab was the first immune checkpoint inhibitor approved for this indication, followed by nivolumab and pembrolizumab. Many ongoing trials are evaluating these molecules in the postoperative setting, alone or in combination with other therapies. Preliminary results are promising regarding the treatment of other cutaneous tumors, lung cancers, head and neck squamous cell carcinomas, bladder cancer and renal cell carcinomas. Some data assessing their use for the adjuvant treatment of esophageal, colorectal, ovarian cancer and other solid tumors are similarly emerging.
Novel and Expanded Oncology Drug Approvals of 2016-PART 1: New Options in Solid Tumor Management. [2021]The nonradiologic medical management of solid tumors has evolved from the use of traditional cytotoxic agents to modern targeted therapies, monoclonal antibodies, and immunotherapies. Advances in the understanding of cancer biology and therapeutic strategies have resulted in increasing numbers of new drug applications and approvals. Consequently, practicing oncologists need to learn how the newly available agents function and what toxicities to watch for, as well as ways to optimize the use of both new drugs and previously approved drugs with new indications. In 2016, the US Food and Drug Administration approved three novel drugs for the treatment of solid malignancies-olaratumab in selected patients with soft-tissue sarcoma, atezolizumab for the treatment of bladder cancer, and rucaparib for the treatment of ovarian cancer; also in 2016, the use of previously approved anticancer agents (including atezolizumab) was expanded into 11 new patient populations. The diversity of options for patients is evident in the broad range of the 2016 approvals, which include immune checkpoint inhibitors, targeted therapies, monoclonal antibodies, and traditional cytotoxic agents. This article focuses on the new agents and indications that emerged in 2016 for solid tumor treatment. We review the drug indications, mechanisms of action, pivotal trial data, pertinent toxicities, use in special populations, and the appropriate clinical contexts for treatment planning.
[Chemotherapy for metastased non-small cell lung cancer]. [2013]Only a select group of patients with metastased non-small cell lung cancer are eligible for treatment with chemotherapy. The standard treatment for patients with a good performance score, and possibly also for those with physical limitations as a consequence of the disease, is chemotherapy consisting of cisplatin or carboplatin in combination with a third-generation cytotoxic agent together with maximum supportive care. The optimal duration of this chemotherapy treatment is at least 3 to 4 cures, less in the case of disease progression. For older patients (> 70 years) with a good performance score, chemotherapy with maximum supportive care is the standard treatment. However, which form of chemotherapy should be given is not yet clear. Symptomatic improvement is important for improving the quality of life. For patients with tumour relapse or disease progression after first-line chemotherapy who still have a good performance score, the standard treatment is once again chemotherapy with maximum supportive care, as this improves the chance of survival and quality of life, and is possibly cost effective.
[Efficacy of MVP chemotherapy combined with concurrent radiotherapy for advanced non-small cell lung cancer]. [2011]To observe the effects of MVP chemotherapy combined with concurrent radiotherapy for stage IIIB-IV non-small cell lung cancer.
The Current Landscape of Immune Checkpoint Inhibition for Solid Malignancies. [2020]Immunotherapy has led to unprecedented improvement in the treatment and prognosis of high-risk resectable and metastatic disease across cancer types. Nowhere is this better highlighted than in the management of advanced and metastatic melanoma with the introduction of molecularly targeted therapies and immune checkpoint inhibitors. Following their success in melanoma, immunotherapies have also been evaluated and their use approved in the management across a variety of other solid malignancies in the neoadjuvant, adjuvant, and advanced/metastatic setting. This review provides an overview of the current landscape of immune checkpoint inhibition for solid malignancies.