Larotrectinib Sulfate for Fibrosarcoma

Phase-Based Estimates
1
Effectiveness
2
Safety
Montefiore Medical Center - Moses Campus, Bronx, NY
Fibrosarcoma+9 More
Larotrectinib Sulfate - Drug
Eligibility
< 65
All Sexes
Eligible conditions
Fibrosarcoma

Study Summary

This study is evaluating whether a drug called larotrectinib may help treat patients with certain types of cancer.

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Eligible Conditions

  • Fibrosarcoma
  • Central Nervous System Neoplasms
  • Cancer
  • Nervous System Neoplasms
  • Acute Disease
  • Leukemia
  • Refractory Acute Leukemia
  • Neoplasms
  • Solid Neoplasms
  • Infantile Fibrosarcoma
  • Recurrent Acute Leukemia

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Larotrectinib Sulfate will improve 1 primary outcome and 9 secondary outcomes in patients with Fibrosarcoma. Measurement will happen over the course of From first observation of either partial response (PR) or complete response (CR) until either the first observation of progressive disease (PD) (event) or last known observation of the patient (censored observation), assessed up to 5 years.

Year 5
Percentage of patients with TRK fusion solid tumors with detectable circulating tumor deoxyribonucleic acid (DNA)
Year 5
DoR of children with newly diagnosed TRK fusion solid tumors other than IFS treated with neoadjuvant larotrectinib prior to local control
Duration of response (DoR) of children with IFS treated with neoadjuvant larotrectinib prior to local control
Up to 5 years
EFS of children with newly diagnosed TRK fusion solid tumors other than IFS treated with neoadjuvant larotrectinib prior to local control
Event-free survival (EFS) of children with IFS treated with neoadjuvant larotrectinib prior to local control
Incidence of adverse events
ORR of children with newly diagnosed TRK fusion solid tumors other than IFS treated with neoadjuvant larotrectinib prior to local control
OS of children with newly diagnosed TRK fusion solid tumors other than IFS treated with neoadjuvant larotrectinib prior to local control
Objective response rate (ORR) of children with infantile fibrosarcoma (IFS) treated with neoadjuvant larotrectinib prior to local control
Overall survival (OS) of children with IFS treated with neoadjuvant larotrectinib prior to local control

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Control
Treatment (larotrectinib)

This trial requires 70 total participants across 2 different treatment groups

This trial involves 2 different treatments. Larotrectinib Sulfate 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 2 and have already been tested with other people.

Treatment (larotrectinib)
Drug
Patients receive larotrectinib PO or by NG or G-tube BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity, or complete surgical resection of tumor.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 5 years for reporting.

Closest Location

Montefiore Medical Center - Moses Campus - Bronx, NY

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. You must have received newly diagnosed for Fibrosarcoma or one of the other 9 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients with a histologic diagnosis of infantile fibrosarcoma and an NTRK1, NTRK2, or NTRK3 fusion identified in a Clinical Laboratory Improvement Act/College of American Pathologists (CLIA/CAP) certified laboratory are eligible for Cohort A show original
COHORT C: Patients must have a histologic diagnosis of relapsed or refractory acute leukemia with an NTRK1, NTRK2, or NTRK3 fusion as determined by a CLIA/CAP certified laboratory show original
Patients must have a histologic diagnosis of any solid tumor other than infantile fibrosarcoma, including central nervous system (CNS) tumors but excluding high grade gliomas show original
To be eligible for this study, patients must have a Lansky or Karnofsky performance status score of >= 50, corresponding to ECOG categories 0, 1 or 2 show original
Patients who have surgery and no other anti-cancer therapies will be eligible for the study. show original
Cohort C includes patients who have relapsed leukemia and have fully recovered from the acute toxic effects of all prior anti-cancer therapy show original
Patients who have received prior radiation therapy for their tumors are not eligible show original
Patients with leukemia must have at least 5% blasts in their bone marrow show original
COHORTS C AND D: Prior radiotherapy is permitted, but other than surgical resection is not. show original
If not eligible due to prior anticancer therapy, patients may be eligible for the larotrectinib arm of Pediatric MATCH (APEC1621A) or for treatment with commercial larotrectinib outside of the study. 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.

What are the signs of fibrosarcoma?

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This case illustrates the nonspecific symptoms of a disease like chronic pain after sarcoma, and shows the value of obtaining a thorough history, including the presence of any signs of adhd or depression, to provide an accurate diagnosis.

Unverified Answer

What causes fibrosarcoma?

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Although there has always been an interest in studying fibrosarcoma, there have been very few studies. It could be due to ignorance of its underlying biology, and/or the relatively low prevalence of this tumor. If these studies do exist, there has been a paucity of data. It would help if more were known about what causes fibrosarcoma. Given that fibrosarcoma is a slow growing tumor (about 6-10 years to get evident), we can only assume its underlying causes must be more prevalent than the incidence of this tumor indicates. It is highly likely that if more information is available, it could provide a better understanding of its underlying causes.

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Can fibrosarcoma be cured?

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Cisplatin-based drug combinations can produce substantial tumor shrinkage, and can help stabilize or reverse some of the patient symptoms. However, there is still no guarantee that fibrosarcoma can be cured. Continued efforts are necessary to develop new effective tumor therapy and to identify more reliable and objective predictors of response.

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What are common treatments for fibrosarcoma?

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There is no single treatment that is perfect for all patients with the disease. Patients are treated based on the specific tumor, size, stage, and their overall health and well-being. A multidisciplinary approach in the treatment of this disease is recommended. Treatment varies due to the stage, site, and overall progress of the tumor. Patients who receive chemotherapy respond to this treatment but have a high relapse risk of 50% over a 3-year interval. Patients may choose to undergo surgery or radiotherapy to remove or stabilize the tumor.

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

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Fibrosarcoma appears to be increasing in the United States in both children and adults. The present estimates of prevalence of fibrosarcoma vary significantly from previous studies. The incidence of cases in the U.S. appears to be on the rise as evidenced by the incidence rates reported in this study. Therefore, this study identifies a potential target for prevention in the U.S. and establishes a rationale for the need for further research.

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What is fibrosarcoma?

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This paper summarizes fibrosarcomas in order to aid the pathologist in classification. Clinically, the histopathological features of these tumors must be considered in combination with the stage at time of examination and the patient's clinical condition. Fibrosarcomas must be considered in all patients, because a significant number of this aggressive tumor subtypes have a benign behavior and their presence must be accounted for cautiously.

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Is larotrectinib sulfate safe for people?

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Larotrectinib sulfate (R-CH2-L-L-Phe-L-Tyr-L-L-Met-NH2) is generally well tolerated in people with ALT-positive renal cell carcinoma. It is not appreciably metabolized or affected by CYP3A4 or CYP2C8, although it does interact with other medications, including erythromycin, rifampicin, and ritonavir. Further studies including the treatment of people with liver dysfunction or kidney failure are warranted.

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What are the latest developments in larotrectinib sulfate for therapeutic use?

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Larotrectinib sulfate is showing promise in adult patients with advanced fibrosarcoma harboring the EML4-ALK fusion. Data from a recent study reveals an initial, single-arm, multicenter, clinical trial to assess the safety, tolerability, and efficacy of larotrectinib sulfate in patients with advanced soft tissue sarcoma.

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What are the chances of developing fibrosarcoma?

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Approximately 1 woman of every 1,000 will develop fibrosarcoma over the course of her life while 1 woman of every 50 will survive to age 71.

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Have there been other clinical trials involving larotrectinib sulfate?

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[It remains unclear if larotrectinib deserves an 'A' label, according to the new criteria, because more clinical trials have to be performed in order to confirm these preliminary results]: larotrectinib can be used as a standard of care treatment for EGFR-mutated non-small-cell lung cancer (NSCLC), especially locally advanced NSCLC. In addition to improving survival, larotrectinib also provides a response rate of approximately 10-14% as compared to historical controls.

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Does larotrectinib sulfate improve quality of life for those with fibrosarcoma?

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Larotrectinib sulfate improved quality of life for those with unresectable fibrosarcoma. QoL assessment is important to monitor the efficacy of larotrectinib sulfate in Phase III clinical studies.

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Has larotrectinib sulfate proven to be more effective than a placebo?

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Larotrectinib sulfate was significantly more effective than a placebo in patients with sarcoma with a good performance status. Patients receiving larotrectinib sulfate experienced a significant improvement in FASM (pain, fatigue, anemia, and weight loss), and a significant improvement in ECOG2"

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