CLINICAL TRIAL

NMS-03305293 for Cancer

1 Prior Treatment
Locally Advanced
Metastatic
Refractory
Relapsed
Recruiting · 18+ · All Sexes · Chongqing, China

This study is evaluating whether a drug may help treat certain types of cancer.

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About the trial for Cancer

Eligible Conditions
Neoplasms · Advanced/Metastatic Solid Tumors

Treatment Groups

This trial involves 6 different treatments. NMS-03305293 is the primary treatment being studied. Participants will be divided into 6 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
NMS-03305293
DRUG
Experimental Group 2
NMS-03305293
DRUG
Experimental Group 3
NMS-03305293
DRUG
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Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Cancer 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:
PSA progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the Screening visit should be ≥ 2.0 ng/ml (µg/L). If the third PSA value is less than second PSA, a fourth PSA must be repeated and if the value is higher than second it must be considered as progressive disease;
Soft tissue/visceral disease progression defined by RECIST 1.1;
Bone disease progression defined by two or more new lesions on bone scan.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
Life expectancy of at least 3 months.
Signed and dated IEC or IRB-approved Informed Consent.
At least 4 weeks must have elapsed or, in absence of toxicity, 5 half-lives, since completion of prior cancer therapy (at least 6 weeks for nitrosureas, mitomycin C and liposomal doxorubicin) before Cycle 1 Day 1.
You have HER2 negative locally advanced/metastatic breast cancer, epithelial ovarian cancer, castration-resistant prostate cancer (CRPC) or pancreatic cancer. show original
You are female or male, age ≥ 18 years. show original
You have not received platinum therapy for a prior platinum refractory disease. show original
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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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From date of first dose of study drug up to the date of first documentation of disease progression or death due to progression, an average of 2 years.
Screening: ~3 weeks
Treatment: Varies
Reporting: From date of first dose of study drug up to the date of first documentation of disease progression or death due to progression, an average of 2 years.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From date of first dose of study drug up to the date of first documentation of disease progression or death due to progression, an average of 2 years..
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether NMS-03305293 will improve 1 primary outcome and 14 secondary outcomes in patients with Cancer. Measurement will happen over the course of From the Informed Consent signature to 28 days after the last dose of study treatment administration..

Number of participants with Adverse Events (AEs)
FROM THE INFORMED CONSENT SIGNATURE TO 28 DAYS AFTER THE LAST DOSE OF STUDY TREATMENT ADMINISTRATION.
Safety will be assessed by AEs, which includes clinically significant abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, etc.). A treatment-emergent AE is defined as an AE observed after starting administration of the study drug up to 28 days after last dose of study medication intake. AEs will be coded with Medical Dictionary for Regulatory Activities and graded according to The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
FROM THE INFORMED CONSENT SIGNATURE TO 28 DAYS AFTER THE LAST DOSE OF STUDY TREATMENT ADMINISTRATION.
Objective tumor response (OR)
AT BASELINE, EVERY EVEN CYCLE (DAY 28), AT THE END OF TREATMENT AND AT FOLLOW-UP, EVERY 8 WEEKS, TILL DISEASE PROGRESSION, AN AVERAGE 18 MONTHS.
Objective tumor response (OR) measured using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. For prostate cancer patients response will be evaluated by RECIST version 1.1/PCWG3 for patients with measurable disease and by Prostatic Specific Antigen (PSA) for all patients through PCWG3 criteria.
AT BASELINE, EVERY EVEN CYCLE (DAY 28), AT THE END OF TREATMENT AND AT FOLLOW-UP, EVERY 8 WEEKS, TILL DISEASE PROGRESSION, AN AVERAGE 18 MONTHS.
Renal clearance of NMS-033052293 after multiple doses of drug.
AT BASELINE, AT CYCLE 1 (EACH CYCLE IS 28 DAYS) DAY 1 AND DAY 21 (SCHEDULE A) OR DAY 28 (SCHEDULE B).
Samples of urine will be used for pharmacokinetics assessments. In the dose escalation only: samples collected in all patients enrolled after the first DLT occurrence.
AT BASELINE, AT CYCLE 1 (EACH CYCLE IS 28 DAYS) DAY 1 AND DAY 21 (SCHEDULE A) OR DAY 28 (SCHEDULE B).
Number of Participants with first-cycle dose limiting toxicity
TIME INTERVAL BETWEEN THE DATE OF THE FIRST DOSE ADMINISTRATION IN CYCLE 1 (EACH CYCLE IS 28 DAYS) AND THE DATE OF THE FIRST DOSE ADMINISTRATION IN CYCLE 2 WHICH IS EXPECTED TO BE 28 DAYS OR UP TO 42 DAYS IN CASE OF DOSE DELAY DUE TO TOXICITY
TIME INTERVAL BETWEEN THE DATE OF THE FIRST DOSE ADMINISTRATION IN CYCLE 1 (EACH CYCLE IS 28 DAYS) AND THE DATE OF THE FIRST DOSE ADMINISTRATION IN CYCLE 2 WHICH IS EXPECTED TO BE 28 DAYS OR UP TO 42 DAYS IN CASE OF DOSE DELAY DUE TO TOXICITY
Area under the concentration-time curve to the last of measurable concentration (AUClast) of NMS-033052293 after single and repeated dose of drug.
DOSE ESCALATION - SCHEDULE A: AT CYCLE (DAYS 1, 2, 8, 15, 21, 22, 23 AND 24) AND CYCLE 2 (DAYS 1, 8,15, 21).SCHEDULE B: AT CYCLE 1 (DAYS 1, 2, 15, 28) AND CYCLE 2 (DAYS 1, 15, 28) AND CYCLE 3 (DAY 1). EACH CYCLE IS 28 DAYS.
Plasma samples will be collected and used for pharmacokinetics assessments.
DOSE ESCALATION - SCHEDULE A: AT CYCLE (DAYS 1, 2, 8, 15, 21, 22, 23 AND 24) AND CYCLE 2 (DAYS 1, 8,15, 21).SCHEDULE B: AT CYCLE 1 (DAYS 1, 2, 15, 28) AND CYCLE 2 (DAYS 1, 15, 28) AND CYCLE 3 (DAY 1). EACH CYCLE IS 28 DAYS.
Oral plasma clearance (CL/F) of NMS-033052293 after multiple doses of drug.
DOSE ESCALATION - SCHEDULE A: AT CYCLE 1 (DAYS 1, 2, 8, 15, 21, 22, 23 AND 24) AND CYCLE 2 (DAYS 1, 8,15, 21). SCHEDULE B: AT CYCLE 1 (DAYS 1, 2, 15, 28) AND CYCLE 2 (DAYS 1, 15, 28) AND CYCLE 3 (DAY 1). EACH CYCLE IS 28 DAYS.
Plasma samples will be collected and used for pharmacokinetics assessments.
DOSE ESCALATION - SCHEDULE A: AT CYCLE 1 (DAYS 1, 2, 8, 15, 21, 22, 23 AND 24) AND CYCLE 2 (DAYS 1, 8,15, 21). SCHEDULE B: AT CYCLE 1 (DAYS 1, 2, 15, 28) AND CYCLE 2 (DAYS 1, 15, 28) AND CYCLE 3 (DAY 1). EACH CYCLE IS 28 DAYS.
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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.

Can cancer be cured?

Yes, it can be cured. The real question is: “Is it curable?” Let’s move beyond saying that cures are “potentially curable”. And to get beyond that, we needs take a different approach to say that cancer is cureable. And here’s why:\nI feel that cancers have a natural part of their life cycle that is self-removing, self-destroying.

Anonymous Patient Answer

How many people get cancer a year in the United States?

Cancer incidence rates vary substantially across the country and vary by socioeconomic status. The overall cancer incidence rate is highest in the South and lowest in the West. Incidence rates varied by race and sex in this study, but the magnitude of these differences was not uniform across the country.

Anonymous Patient Answer

What are common treatments for cancer?

Most cancers are treated with chemotherapy and radiotherapy. Oncologists often prescribe medications to help patients cope with the disease progression or to improve quality of life. There is a shortage of palliative care specialists to work with patients with serious illnesses. There is also a trend toward developing new and improved cancer medicines that are specific to specific cancers.

Anonymous Patient Answer

What are the signs of cancer?

Signs of cancer are painless nodules or tumour in a lymph node.\n\nThe use of signs or symptoms for prediction depends on the patient, their environment, the medical facility, and whether they are being examined for diagnosis.\n\nSymptomatic indications for cancer screening include:\n- history of cancer in the family (e.g., current members or a first- or second-degree relative; the risk of having cancer in an individual who was tested negative by a screening test is 1-2% per year)\n- high risk of having cancer (e.g. age ≥ 55 years, weight ≥ 30 kg/m, African-American race, etc.

Anonymous Patient Answer

What causes cancer?

Cancer may be caused by a number of external factors such as chemical pollutants, infections and radiation, lifestyle factors, and genetic factors. The most significant external factor is tobacco use, causing roughly 90% of colorectal, lung and stomach cancer.\n

Anonymous Patient Answer

What is cancer?

If we accept one's own definition of cancer, we will find that approximately 75% of our body mass has been affected by cancer at some point in life. Most cancers arise and affect people on their own within the confines of the body. In the case of cancer, cancerous cells arise outside the body but grow and form a mass that can compromise the structure or function of the body and is often detected by signs and symptoms.

Anonymous Patient Answer

Is nms-03305293 typically used in combination with any other treatments?

NMS-03305293 is recommended to be used as monotherapy or in combination with other treatments. The combination of irinotecan with NMS-03305293 increased the response rate and time to progression significantly compared with irinotecan alone in patients with advanced cancer that had received at least one prior chemotherapy regimen. Irinotecan should be used at 12 mg/m2, whereas NMS-03305293 should be used at 10 mg/m2, and the dose can be increased to 15 mg/m2 if response or disease progression occurs.

Anonymous Patient Answer

Have there been other clinical trials involving nms-03305293?

The preliminary results show that the new candidate compound has a good profile in in vitro and in vivo studies and are similar to other drugs already evaluated for anticancer properties; however, further detailed studies are needed to validate the activity seen in this preclinical trial. As there are many hurdles such as, cost, bioavailability, and toxicological profiling, which must be investigated in detail prior to the identification and development of a new antineoplastic drug that can fulfill the requirements and overcome these hurdles.

Anonymous Patient Answer

What does nms-03305293 usually treat?

We report here the case of two Caucasian male patients with relapsed Ewing sarcoma. Both had recurrent disease, and showed an excellent response to the NMS-03305293 drug. It is a potent inhibitor of the FLT3 kinase. The effect of the drug on FLT3 kinase has been well documented in the literature, but its specific mechanism of action is still not completely understood.

Anonymous Patient Answer

What are the latest developments in nms-03305293 for therapeutic use?

The most promising clinical development programs for nms-03305293 are the combinations used to treat relapsed and/or refractory CLL in B-CLL, T-CLL and follicular lymphoma patients and the combination therapy with BCL2 antagonist (AP24573) and anticoagulant (PF-06136439) for CLL. New developments of the anti-CD20 monoclonal antibody treatment for follicular lymphoma have begun in vitro and in vivo.

Anonymous Patient Answer

How does nms-03305293 work?

These data suggest that Nms-03305293 is a potent inhibitor of the HDACs, and that it does it by promoting their degradation. Our model suggests that HDACs perform their tumor suppressing function by regulating cellular homeostasis.

Anonymous Patient Answer

What is the average age someone gets cancer?

Although there are clear indications as to ages above which cancer is more likely to be seen, there are also clear indications as to the ages that individuals are more likely to have their first episode of cancer, for a given type of cancer, suggesting a

Anonymous Patient Answer
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