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Study on the Effectiveness of Entrectinib and Other Drug Combinations for Patients with Advanced Solid Tumors, Multiple Myeloma, or Non-Hodgkin Lymphoma

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What is this study about?

This clinical trial is focused on studying the effects of targeted anti-cancer drugs on patients with advanced solid tumors, non-Hodgkin lymphoma, or multiple myeloma. These are types of cancers that have spread or are difficult to treat with standard therapies. The study aims to explore how these drugs, which are already available on the market, can be used to treat these cancers based on specific genetic or protein markers found in the tumors. These markers can help predict how well a patient might respond to a particular drug.

The trial includes a variety of medications, such as Rozlytrek, Cabometyx, Lenvima, Tepmetko, Retsevmo, Vectibix, Xalkori, Zejula, Tarceva, Inlyta, Pemazyre, Stivarga, Cotellic, Mekinist, Rubraca, Tecentriq, Keytruda, Tasigna, Erivedge, Talzenna, Sutent, Imfinzi, Avastin, Opdivo, Piqray, Lynparza, Zelboraf, Herceptin, Perjeta, Yervoy, Tafinlar, Lorviqua, and Vizimpro. Some of these drugs have code names, such as XL-184 for Cabometyx and LOXO-292 for Retsevmo. The study also involves the use of a placebo for comparison.

Participants in the study will receive one of these medications based on the specific characteristics of their cancer. The study will monitor the effects of the treatment over time, looking at how the cancer responds and any side effects that may occur. The goal is to better understand which drugs work best for different types of cancer and to provide patients with access to potentially effective treatments. The study is expected to continue until 2027, allowing researchers to gather comprehensive data on the long-term effects and benefits of these treatments.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, type of cancer, and previous treatments.

A fresh tumor biopsy is required for biomarker testing, unless exceptions apply.

2 treatment assignment

Treatment is assigned based on the molecular profile of the tumor.

The study includes various targeted anti-cancer drugs, such as entrectinib, cabozantinib, and lenvatinib, among others.

3 medication administration

Medications are administered either orally or intravenously, depending on the specific drug.

For example, Rozlytrek is taken as 200 mg hard capsules orally, while Tecentriq is given as a 1,200 mg solution for infusion.

4 monitoring and assessments

Regular monitoring is conducted to assess the tumor’s response to treatment and any side effects.

Assessments include physical exams, imaging tests, and laboratory tests.

5 evaluation of treatment response

The primary endpoints include the percentage of patients treated based on their tumor profile and the objective tumor response.

Secondary endpoints focus on progression-free survival and overall survival.

6 completion of study participation

Study participation continues until the treatment is no longer effective, side effects become too severe, or the study ends.

The estimated end date for the study is September 2027.

Who Can Join the Study?

  • The patient must be an adult, which means they are over 18 years old, and have a confirmed diagnosis of an advanced solid tumor, multiple myeloma, or non-Hodgkin lymphoma. The disease must be getting worse despite previous treatments, or there are no other treatments available.
  • Women who can have children and men must agree to use reliable birth control methods during the study and for four months after finishing the study treatment. Men should avoid making a partner pregnant during this time.
  • The patient must have an ECOG performance status of 0 to 2. This is a scale that measures how well a patient can perform daily activities.
  • The patient must have acceptable organ function, which includes specific levels of blood cells, liver, and kidney function. These levels are measured by blood tests.
  • The patient must have a disease that can be measured by physical exams or imaging tests, according to specific criteria for different types of cancer.
  • The patient must have results from a test that looks at the tumor’s genes or proteins. This test can be done using various methods and must show a change that can be targeted by a drug.
  • The patient must have a tumor profile that suggests they might benefit from one of the approved targeted anti-cancer drugs included in the study.
  • A new sample of the tumor, taken within two months before joining the study, is required for further testing. This sample should not have been treated with any anti-cancer therapy during those two months.
  • The patient must be able to understand and agree to sign a consent form, which is a document explaining the study and what participation involves.
  • If the study involves taking medication by mouth, the patient must be able to swallow pills and not have any condition that affects how their body absorbs the medication.

Who Cannot Join the Study?

  • Patients who have a medical condition other than an advanced solid tumor, Non-Hodgkin lymphoma, or Multiple myeloma cannot participate. These are specific types of cancer.
  • Patients who do not have a genomic- or protein expression variant that is known to be a target for the drug or predicts sensitivity to the drug cannot participate. This means the cancer must have certain characteristics that the drug can act on.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This refers to groups of people who might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Stichting OLVG Amsterdam The Netherlands
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Frisius Heerenveen The Netherlands
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Ziekenhuis Gelderse Vallei Stichting Ede The Netherlands
Haga Hospital Hague The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Amphia Hospital Breda The Netherlands
Tergooiziekenhuizen Hilversum The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg Venlo The Netherlands
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
Ziekenhuis Nij Smellinghe Drachten The Netherlands
Maxima Medisch Centrum Veldhoven The Netherlands
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Meander Medical Center Amersfoort The Netherlands
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Deventer Ziekenhuis Deventer The Netherlands
Reinier de Graaf Groep Delft The Netherlands
Medical Center Haaglanden Leidschendam The Netherlands
Stichting Treant Ziekenhuiszorg Emmen The Netherlands
Bravis Ziekenhuis Roosendaal The Netherlands
Gelre Hospitals Zutphen The Netherlands
Netherlands Cancer Institute Amsterdam The Netherlands
Spaarne Gasthuis Hoofddorp The Netherlands
Ltudc Ujozlqipciaw Mylyeww Cdxjlsd (lkoss Leiden The Netherlands
Rvqzpqsqp Znzekznkjh Secpwwoge Arnhem The Netherlands
Uwrjwlkcgwsq Mhdywhu Cxwhiam Glquasxhv Groningen The Netherlands
Setxjrfha Mgrrcte Zigyzjxgmi Groningen The Netherlands
Byxvvbc Zgvbprfhtr Gorinchem The Netherlands
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
19.08.2016

Trial locations

Investigated drugs:

Targeted Anti-cancer Drugs are used in this trial to treat patients with advanced solid tumors, multiple myeloma, or non-Hodgkin lymphoma. These drugs are specifically chosen because they target certain genetic or protein changes in the cancer cells. By focusing on these specific changes, the drugs aim to stop the growth of cancer cells or kill them, potentially leading to better outcomes for patients. The trial seeks to understand how effective these drugs are and what side effects they might cause.

Investigated diseases:

Advanced Solid Tumor – This term refers to a group of cancers that have spread beyond their original site and are not confined to a single location. These tumors can affect various organs and tissues, leading to complex symptoms depending on the affected areas. As the disease progresses, it may cause pain, organ dysfunction, and other systemic effects. The growth and spread of these tumors can vary significantly, influenced by the type of cancer and individual patient factors.

Non-Hodgkin Lymphoma – This is a type of cancer that originates in the lymphatic system, which is part of the body’s immune system. It involves the abnormal growth of lymphocytes, a type of white blood cell, which can form tumors in lymph nodes and other tissues. The disease can progress at different rates, with some forms being slow-growing and others more aggressive. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss.

Multiple Myeloma – This is a cancer of plasma cells, which are a type of white blood cell found in the bone marrow. The disease leads to the accumulation of abnormal plasma cells in the bone marrow, which can interfere with the production of normal blood cells. As it progresses, multiple myeloma can cause bone pain, fractures, anemia, kidney dysfunction, and increased susceptibility to infections. The progression of the disease can vary, with periods of stability and active disease.

Trial ID:
2023-509152-33-00
Protocol code:
M15DRU
NCT ID:
NCT02925234
Trial Phase:
Therapeutic exploratory (Phase II)

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