Study for Patients with Advanced Malignancies: Continued Treatment with Parsaclisib Alone or with Itacitinib, Ruxolitinib, Ibrutinib, or Tafasitamab

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What is this study about?

This clinical trial is focused on studying treatments for people with advanced cancers and certain immune system diseases. The study involves a medication called parsaclisib, which is being tested either on its own or in combination with other treatments. These additional treatments include itacitinib, ruxolitinib, ibrutinib, and tafasitamab. The purpose of the study is to continue providing treatment and to monitor the safety of these medications in participants who have been part of previous studies involving parsaclisib.

Participants in this study will continue to receive their treatment as they have been, and the study will observe how they respond to the medication over time. The study will not introduce any new treatments but will focus on maintaining the current treatment regimen. The study aims to ensure that participants continue to benefit from the treatment and to gather information on any side effects they may experience.

The study is designed to be open-label, meaning that both the participants and the researchers know which treatments are being administered. This approach helps in closely monitoring the effects of the treatment and ensuring the safety of the participants. The study will continue until the estimated end date, allowing researchers to collect comprehensive data on the long-term effects and safety of the treatments being studied.

1 enrollment in the study

Upon joining the study, you will continue the treatment you were receiving in a previous clinical study involving parsaclisib.

Your participation is based on your current tolerance and benefit from the treatment as determined by the study investigator.

2 treatment continuation

You will receive parsaclisib either alone or in combination with other medications such as itacitinib, ruxolitinib, ibrutinib, or tafasitamab.

The form of parsaclisib is a tablet taken orally.

3 medication administration

If you are taking ruxolitinib, it will be in the form of Jakavi 5 mg tablets for oral use.

If you are taking ibrutinib, it will be in the form of IMBRUVICA 140 mg hard capsules for oral use.

If you are taking tafasitamab, it will be administered as an intravenous infusion using MINJUVI 200 mg powder for concentrate for solution for infusion.

4 safety evaluation

Throughout the study, your safety will be closely monitored to assess any adverse effects or serious adverse effects from the treatment.

Regular check-ups and assessments will be conducted to ensure your well-being.

5 study duration

The study is expected to continue until September 30, 2024.

Your participation will involve regular visits and adherence to the treatment plan as outlined in the study protocol.

Who Can Join the Study?

  • Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of parsaclisib.
  • Currently tolerating treatment in the parent Protocol.
  • Currently receiving clinical benefit from treatment with parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, ibrutinib, or tafasitamab (including participants who remain on tafasitamab alone) as determined by the investigator.
  • Has at least stable disease, as determined by the investigator.
  • Has demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
  • Willingness and ability to comply with scheduled visits, treatment plans, including PJP prophylaxis (a preventive treatment for a type of lung infection), and any other study procedures indicated in this Protocol.
  • Willingness to avoid pregnancy or fathering children based on the criteria described in Protocol section 5.1.
  • Ability to comprehend and willingness to sign an ICF (Informed Consent Form).

Who Cannot Join the Study?

  • Patients with advanced malignancies (serious forms of cancer) cannot participate.
  • Patients with IAI diseases (immune system-related diseases) are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Centre Antoine Lacassagne Nice France
Virgen del Rocío University Hospital Sevilla Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Universita’ Di Pisa Pisa Italy
Assistance Publique Hopitaux De Paris Paris France
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie Lublin Poland
Region Midtjylland Aarhus Denmark
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Rigshospitalet Copenhagen Denmark
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Zealand University Hospital, Department of Cardiology Roskilde Denmark
Ospedale S. Eugenio Rome Italy
Azienda Unita Sanitaria Locale Della Romagna Ravenna Italy
Isakvmre Rvzarmbxo Pql Lt Svdfql Dxb Tebwht Dprc Ajiiirk Iiig Sqqznl Meldola Italy
Ijbndnjr Cgfofz Dlstuplpygimqgtbk L'hospitalet De Llobregat Spain
Wtpenmilggv Wyerotnfiorenxfchrbu Crjopfu Oedukcxmu I Tonqipoljkptw Iv Mdrfzoobzsv W Laafo Lodz Poland
Chslcmdlq Uyeihzyaxeesqb Smxxhnzxe Woluwe-Saint-Lambert Belgium
Seqfcgd Soyqvtlaydcivjl Iwy Jauxfpmi Sqovzpgelhxf W Newzq Slpgx Nowy Sacz Poland
Axfdmot Urrpg Sunipfuwu Lvckjf Dd Bdmwybi Bologna Italy
Hzrewyjw Ujpynshotvoxx Hgykeaiu Thhrw y Pyzkhu Iwdaojyx Ctzuxf dutzsjixieuyfmktp (cmvv Badalona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
01.09.2020
Czechia Czechia
Not recruiting
01.09.2020
Denmark Denmark
Not recruiting
01.09.2020
France France
Not recruiting
01.09.2020
Italy Italy
Not recruiting
01.09.2020
Poland Poland
Not recruiting
01.09.2020
Spain Spain
Not recruiting
01.09.2020
Sweden Sweden
Not recruiting
01.09.2020

Trial locations

Parsaclisib is a medication being studied for its ability to help treat certain types of cancer. It works by blocking specific proteins in the body that help cancer cells grow. In this trial, participants who were already taking Parsaclisib in previous studies can continue their treatment to see if it remains safe and effective over a longer period.

Itacitinib is another medication involved in this trial. It is used to help manage conditions related to the immune system. Itacitinib works by interfering with certain signals in the body that can cause inflammation and other immune responses. In this study, it is being used in combination with Parsaclisib to see if the two medications together can provide better results for patients.

Ruxolitinib is a medication that helps reduce inflammation and is often used to treat certain blood disorders. It works by blocking specific enzymes in the body that contribute to inflammation and abnormal blood cell production. In this trial, Ruxolitinib is being combined with Parsaclisib to evaluate if this combination can improve treatment outcomes for patients.

Ibrutinib is a medication that targets certain proteins in cancer cells, helping to slow down or stop their growth. It is commonly used to treat various types of blood cancers. In this study, Ibrutinib is being used alongside Parsaclisib to determine if the combination is more effective than using either medication alone.

Tafasitamab is a medication that helps the immune system recognize and attack cancer cells. It is often used in the treatment of certain types of lymphoma. In this trial, Tafasitamab is being used both in combination with Parsaclisib and on its own to see how well it works in treating patients who have been part of previous studies.

Advanced Malignancies – Advanced malignancies refer to cancers that have progressed to a late stage, often spreading beyond their original site to other parts of the body. These malignancies can affect various organs and tissues, leading to a range of symptoms depending on the location and extent of the spread. As the disease progresses, it may cause significant changes in bodily functions and overall health. The progression can vary greatly depending on the type of cancer and individual patient factors. Advanced malignancies often require complex management due to their widespread impact on the body. The disease can lead to a decline in physical abilities and quality of life as it advances.

Idiopathic Autoimmune Diseases – Idiopathic autoimmune diseases are conditions where the immune system mistakenly attacks the body’s own tissues, and the exact cause of this immune response is unknown. These diseases can affect various parts of the body, leading to inflammation and damage to healthy tissues. The progression of idiopathic autoimmune diseases can vary widely, with some individuals experiencing mild symptoms and others facing severe complications. Over time, these diseases can lead to chronic pain, fatigue, and organ dysfunction. The course of the disease is often unpredictable, with periods of remission and flare-ups. As the disease progresses, it can significantly impact daily life and overall well-being.

Trial ID:
2022-501687-18-00
Protocol code:
INCB 50465-801
Trial Phase:
Therapeutic exploratory (Phase II)

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