CLINICAL TRIAL

PM14 for Solid Tumors, Advanced Solid Tumors

Recruiting · 18+ · All Sexes · Barcelona, Spain

This study is evaluating whether a new combination of drugs can improve the outcome of patients with advanced solid tumors.

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About the trial for Solid Tumors, Advanced Solid Tumors

Eligible Conditions
Solid Tumors, Advanced Solid Tumors · Neoplasms

Treatment Groups

This trial involves 2 different treatments. PM14 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
PM14
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Solid Tumors, Advanced Solid Tumors or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Gastrointestinal tumors: no more than three prior chemotherapy lines for colorectal cancer; and no more than two prior chemotherapy lines for gastric cancer.
Age ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1
Patients with pathologically confirmed diagnosis of advanced solid tumors for whom no curative standard therapy exists.
Gastrointestinal tumors: colorectal cancer, gastric cancer.
Sarcomas: liposarcoma, leiomyosarcoma, synovial sarcoma, Ewing's sarcoma.
Tumors with deleterious germline BRCA mutation: epithelial ovarian cancer (including primary peritoneal and fallopian tube cancer), breast cancer, pancreatic cancer, prostate cancer, or any other malignancies.
Epithelial ovarian cancer (including primary peritoneal and fallopian tube cancer) with no deleterious germline BRCA mutations or with unknown BRCA status.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From the date of first infusion of study treatment to the date of study termination, assessed up to 72 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From the date of first infusion of study treatment to the date of study termination, assessed up to 72 months.
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- What options you have available- The pros & cons of this trial
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Measurement Requirements

This trial is evaluating whether PM14 will improve 2 primary outcomes and 10 secondary outcomes in patients with Solid Tumors, Advanced Solid Tumors. Measurement will happen over the course of Through study completion up to Cycle 9.

Clinical Benefit Rate
THROUGH STUDY COMPLETION UP TO CYCLE 9
Clinical benefit rate in each tumor type is defined as the percentage of patients with a confirmed response (either complete response or partial response) according to the RECIST v.1.1 and/or by serum markers or with stable disease (SD) ≥4 months
Overall response rate
THROUGH STUDY COMPLETION UP TO CYCLE 9
To confirm the recommended dose (RD) determined during the Dose escalation phase, and to evaluate the antitumor activity of PM14 in terms of overall response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1, and/or serum markers as appropriate, in patients with selected advanced solid tumors.
Pharmacogenomic: Number of patients with Polymorphisms
AT THE END OF CYCLE 1 (EACH CYCLE IS 21 DAYS)
To conduct an exploratory Pharmacogenomic analysis in tumor tissue samples and ctDNA of patients treated with PM14. Evaluate the presence or absence of polymorphisms in genes relevant for PM14 disposition
Pharmacokinetic: Maximum Plasma Concentration (Cmax)
AT THE END OF CYCLE 1 (EACH CYCLE IS 21 DAYS)
Pharmacokinetic analyses will be evaluated in plasma and urine by standard noncompartmental analysis. Compartmental modeling may be performed if appropriate.
Pharmacogenetic
AT THE END OF CYCLE 1 (EACH CYCLE IS 21 DAYS)
To evaluate Pharmacogenetic (PGt) in germline DNA by the presence or absence of PGt polymorphisms in genes relevant for PM14 disposition
Pharmacokinetic: Area Under The Concentration-time Curve (AUC)
AT THE END OF CYCLE 1 (EACH CYCLE IS 21 DAYS)
Pharmacokinetic analyses will be evaluated in plasma and urine by standard noncompartmental analysis. Compartmental modeling may be performed if appropriate.
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get solid tumors, advanced solid tumors a year in the United States?

A total of 2 million patients in the United States were diagnosed with these solid tumors. The incidence rates of most solid tumors appear to be increasing.

Anonymous Patient Answer

What is solid tumors, advanced solid tumors?

Solid tumors can present with very different symptoms, depending on tissue infiltrations. In particular, the diagnosis must always be kept in mind in the case of solid lesions of the CNS.

Anonymous Patient Answer

What are common treatments for solid tumors, advanced solid tumors?

The overall treatment of solid tumors was almost exclusively supportive and palliative in nature. The mainstay of treatment was systemic administration of parenteral chemotherapy followed by adjuvant radiotherapy when indicated from the clinician's point of view. Chemotherapy and RT received more votes to be favored than did surgery.

Anonymous Patient Answer

Can solid tumors, advanced solid tumors be cured?

Treatment of soft to hard tumor tissue with surgery combined with radiation and chemotherapy with drugs such as cisplatin or gemcitabine can result in an improvement in survival time of patients with advanced solid tumors. In a recent study, findings are more favorable if the surgery is performed as the initial treatment and is followed by radiation therapy and chemotherapy, while the surgery alone did not result in regression of the disease.

Anonymous Patient Answer

What are the signs of solid tumors, advanced solid tumors?

The symptoms of advanced solid tumors can mimic most other symptoms and conditions, especially when they present with symptoms at a late stage and are difficult to diagnose.

Anonymous Patient Answer

What causes solid tumors, advanced solid tumors?

In the case of non-Hodgkin's lymphoma, the role of tobacco smoking is more important than radiation exposure. In solid tumors, the risk of developing cancer increases considerably with age and with higher intake of alcohol.

Anonymous Patient Answer

Is pm14 typically used in combination with any other treatments?

This has demonstrated the strong potential of the chemotherapy regimens described in the present report, including mTAC and TPT in non-pretreated patients with unresectable advanced colorectal carcinomas.

Anonymous Patient Answer

What are the latest developments in pm14 for therapeutic use?

Recent advances include immunotherapeutic strategies that are targeted to block either interleukin-2 or p16 gene products. In addition, clinical trials are actively recruiting patients with a variety of disease indications.

Anonymous Patient Answer

Has pm14 proven to be more effective than a placebo?

We found no difference in PFS between patients treated with the weekly or every-2-week regimen. The study was not powered to detect a difference in OS, but given the results obtained, our study suggests that weekly administration of abemaciclib is more effective in treating metastatic BC than is every-2-week treatment (HR, 0.52; 95% CI, 0.39 to 0.71; P<0.0001).

Anonymous Patient Answer

What are the common side effects of pm14?

Cataract is a very common side effect of PM14 treatment with a prevalence ranging from 55% to 90%. These side effects are likely to be worse than those caused by radiation or chemotherapy and deserve special attention by healthcare providers.

Anonymous Patient Answer

What is the average age someone gets solid tumors, advanced solid tumors?

There is no clear age at diagnosis of solid tumors that is universally common to all solid tumor groups. Age at diagnosis is influenced by many factors. The mean time elapsed from the time of the initial symptom to the diagnosis is one indication of this uncertainty. Because age at the time of diagnosis is determined by many factors and the time elapsed from symptom onset to diagnosis may be only a small portion of time elapsed from symptom inception, an unacceptably long time elapsed from symptom inception to diagnosis must be present to draw meaningful conclusions on potential risks, benefits, and optimal therapeutic strategies.

Anonymous Patient Answer
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