Pimasertib for Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Cancer+20 More
Pimasertib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Cancer

Study Summary

This study is evaluating whether a combination of pimasertib and bintrafusp alfa is safe and effective in treating patients with cancer that has spread to the brain.

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Eligible Conditions

  • Cancer
  • Neoplasms
  • Breast Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Cancer of Skin
  • Carcinoma
  • Melanoma
  • Lung Cancer
  • Stage IVA Lung Cancer AJCC v8
  • Breast Neoplasms
  • Skin Neoplasms
  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Metastatic Lung Non-Small Cell Carcinoma
  • Stage IV Lung Cancer AJCC v8
  • Stage IVB Lung Cancer AJCC v8
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Metastatic Malignant Solid Neoplasm
  • Metastatic Malignant Neoplasm in the Brain
  • Metastatic Melanoma
  • Pathologic Stage IV Cutaneous Melanoma AJCC v8
  • Hormone Receptor Positive Breast Adenocarcinoma
  • Metastatic Triple-Negative Breast Carcinoma
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Lung Neoplasms
  • Prognostic Stage IV Breast Cancer AJCC v8

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Pimasertib will improve 5 primary outcomes and 5 secondary outcomes in patients with Cancer. Measurement will happen over the course of At 4 weeks after first administration of treatment.

Week 4
Recommended phase II dose (Phase I)
Year 2
Duration of response
Month 18
Time to extracranial progression
Month 18
Intracranial progression
Year 2
Time to intracranial progression (Phase II)
Year 2
Overall survival (Phase II)
Up to 2 years
Best achieved extracranial objective response rate
Clinical benefit rate
Dose, duration and frequency of steroid use for symptomatic management
Up to 90 days
Incidence of intracranial and extracranial toxicities and dose-limiting toxicities (Phase I)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Treatment (bintrafusp alfa, pimasertib)

This trial requires 36 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pimasertib 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 & 2 and have already been tested with other people.

Treatment (bintrafusp alfa, pimasertib)Patients receive bintrafusp alfa IV over 1 hour every 2 weeks and pimasertib PO BID on days 1-28. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bintrafusp alfa
Not yet FDA approved
Pimasertib
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 2 years for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
At least one untreated brain lesion that is at least 0.5 cm but less than 3.0 cm in size, as measured in the longest axis, according to modified RECIST 1.1. show original
People with melanoma who have received prior treatment with a PD-1 based therapy and have evidence of progression will need to receive further treatment with a PD-1 based therapy. show original
You are allowed to have prior stereotactic radiosurgery (SRS) with up to 3 lesions, as long as the previous treatment volume did not overlap with the current targets. show original
To have a performance status of 0 or 1 on the ECOG performance scale, you must be fully active, able to carry on all self-care activities, and have no symptoms. show original
People who have received previous treatment with immunotherapy or targeted therapy can participate in this study as long as their last treatment was more than 14 days ago and it did not include a combination of a MEK inhibitor and an anti-PD(L)-1 antibody show original
Age >= 18 years old
This means that a person's life expectancy is more than 12 weeks long. show original
People who take part in a study must be willing to comply with the study's requirements, which often include scheduled visits, treatments, and laboratory tests. show original
Subjects must be free of neurologic signs and symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy in the 10 days prior to beginning protocol therapy
People with non-small cell lung cancer who have received prior treatment with a PD-1 based drug and have evidence that the cancer is progressing will need to receive additional treatment with a PD-1 based therapy. show original

Patient Q&A Section

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

Have there been any new discoveries for treating cancer?

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Our main objective was not to prove the lack of discovery, but to make it obvious that the advancement of research in oncology is still very much ongoing.

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What are common treatments for cancer?

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There is no cure for cancer; treatment is tailored to address the particular disease or tumors that are present. Patients and clinicians should be aware of the most common treatments for cancer and the related comorbidities.

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What are the signs of cancer?

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Some of the most common cancers manifest through symptoms. The presentation can include increased weight, loss of appetite, fever, jaundice, and a red, swollen, or itchy throat. If the cancer occurs in the bones, pain may occur in the affected region. Bone pain may also occur when the cancer affects the eyes. Symptoms may also include feeling tired, feeling as if one has not had enough sleep, or feeling depressed.

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

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In the United States, cancer will become the second most common cause of death (after cardiovascular disease) after non-malignant causes by 2024, with an average of 26 new cases per 100,000 population per year.

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Can cancer be cured?

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In a recent study, findings of this study suggest that current management practices are unlikely to lead to cure. Therefore a more radical approach, such as complete resection of the lesion, will probably be most effective in inducing cures in this disease, and in minimizing the chance of recurrence.

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What causes cancer?

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At the level of a cellular or cellularized entity, cancer may appear for a number of reasons, including genetic mutations to the genome, epigenetic lesions of the genomic information, or, perhaps, some form of epigenetic lesion within the RNA (transcriptional) information or other aspects of messenger RNA (mRNA). This model implies a cell-lineality as one of the reasons why cancer should be included with the other somatic (non-hermaphroditic) diseases. Other than this implication, it may also give some justification for excluding germ-cell cancer. In other words, it may be an alternative view of cancer, rather than a complementary one.

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What is cancer?

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Different cancers have different symptoms. Often, the symptoms cannot be understood or diagnosed. Also, doctors often fail to recognise these symptoms while treating the cancer. Physicians should be aware of symptoms of cancer.

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Does pimasertib improve quality of life for those with cancer?

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Pimasertib was well tolerated in people with a variety of cancers and, unlike other PI3K inhibitors, was associated with an improvement in HR-QOL among patients with solid tumors. Pimasertib has a potential role in cancer, particularly in combination with standard treatment, and warrants further investigation.

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What are the common side effects of pimasertib?

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Pimasertib has a side effect profile similar to the other kinase inhibitors. The most common side effects were rash (18%), gastrointestinal: diarrhea (17%), dizziness (4%), dyspnoea (4%), fatigue (4%), and swelling (3%), and myalgia (3%). Serious adverse effects were observed in about 1,000–1,500 people, most of which were related to the underlying Bcr-Abl tyrosine kinase inhibitor action.

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Is pimasertib safe for people?

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It is considered that pimasertib is generally well tolerated and that no serious side effects were observed in patients in this study and in other clinical studies involving high-dose treatment. In the interim analysis of the first Phase III trial, 4% of patients in the 50 mg arm experienced a serious adverse event, compared to 4.1% of patients in the 100 mg arm and 4.6% of people in the 300 mg arm (n = 491, 0.9%) Overall, the incidence of serious adverse events was not different among dose groups, including the 300 mg group: 1.1% (n = 45); 0.8% (n = 45); and 1.

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What is the average age someone gets cancer?

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the average age people have ever been diagnosed with cancer has risen in the last 100 years. Average age at diagnosis has risen over the lifetime of people in most developed country. This may be due to the improving healthcare throughout the life time. The rise in early diagnosis is not enough to offset the high percentage of people diagnosed with curable cancers. A rise in percentage of people with curable cancers may be due to increasing survival rates in curable cancers since diagnosis is earlier.

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Have there been other clinical trials involving pimasertib?

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The most similar agent to pimasertib is MLN4924 which is now in phase II testing. Pimasertib is also now being tested in the ongoing E7021 trial with the goal of assessing the role that PI3K inhibitors may play in the treatment of breast cancer. It has also now been approved for further testing in a second phase I/II human trial.

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