Study of SBP-101, Nab-Paclitaxel, and Gemcitabine for Patients with Metastatic Pancreatic Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called Metastatic Pancreatic Ductal Adenocarcinoma, which is a form of pancreatic cancer that has spread to other parts of the body. The study is testing a new treatment combination to see if it can help patients live longer. The treatment involves a new drug called SBP-101, which is a small molecule that affects the metabolism of certain compounds in the body. This drug is being tested in combination with two other cancer medications, nab-paclitaxel and gemcitabine. Some participants will receive these medications along with SBP-101, while others will receive a placebo instead of SBP-101.

The purpose of the study is to compare the overall survival of patients who receive the combination of SBP-101, nab-paclitaxel, and gemcitabine with those who receive only nab-paclitaxel and gemcitabine. Participants will be randomly assigned to one of the two groups, and neither the participants nor the researchers will know who is receiving SBP-101 or the placebo. The study will involve regular visits to the clinic for treatment and monitoring, and participants will receive the medications through injections or infusions.

The study will continue for a period of time, during which the health and progress of the participants will be closely monitored. The main goal is to see if the addition of SBP-101 can improve the length of time patients live with this type of cancer. The study will also look at other factors, such as how long it takes for the cancer to progress and the overall response to the treatment. Participants will be asked to complete questionnaires about their quality of life during the study.

1 initial treatment phase

Upon joining the study, the patient will begin treatment with a combination of medications. These include SBP-101, nab-paclitaxel, and gemcitabine. The treatment is designed for individuals with metastatic pancreatic ductal adenocarcinoma who have not received prior treatment for this condition.

The medication SBP-101 is administered as a subcutaneous injection. Nab-paclitaxel is given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. Similarly, gemcitabine is also administered as an intravenous infusion.

2 treatment schedule

The treatment involves regular administration of the medications. The specific dosage and frequency will be determined by the healthcare provider based on the patient’s condition and response to the treatment.

The treatment is expected to continue for a specified duration, which will be communicated by the healthcare team. Regular monitoring and assessments will be conducted to evaluate the patient’s response to the treatment.

3 monitoring and assessments

Throughout the study, the patient’s health and response to the treatment will be closely monitored. This includes regular medical check-ups, blood tests, and imaging studies to assess the progression of the disease and the effectiveness of the treatment.

Quality of life will also be evaluated using specific questionnaires designed to understand the patient’s well-being and any side effects experienced during the treatment.

4 end of treatment evaluation

At the end of the treatment period, a comprehensive evaluation will be conducted to determine the overall survival and progression-free survival of the patient. This involves assessing the time from the start of the treatment until any progression of the disease or death from any cause.

The results of this evaluation will help in understanding the effectiveness of the treatment and its impact on the patient’s health.

Who Can Join the Study?

The patient must have a confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma. This means the cancer started in the pancreas and has spread to other parts of the body.
The patient should not have received any treatment for this type of cancer before. The cancer must have been diagnosed within the last 3 months, and the patient should be expected to receive standard treatment with two drugs called gemcitabine and nab-paclitaxel.
The patient should have a life expectancy of at least 3 months.
The patient must be an adult, aged 18 years or older, and can be either male or female.
Females who can have children must have a negative pregnancy test within 14 days before starting the study treatment and must use a reliable method of birth control. Male patients with partners who can have children should also use a highly effective birth control method during the study and for 6 months after the last dose of the study drug.
The patient must have adequate function of the bone marrow, liver, kidneys, and blood clotting.
The patient must have a QTc interval of 470 milliseconds or less for women and 450 milliseconds or less for men on an ECG (a test that checks the heart’s electrical activity). The QTc interval is a measure of the time it takes for the heart to recharge between beats.
The patient must be willing and able to provide written consent to participate in the study.

Who Cannot Join the Study?

Patients with other types of cancer that have spread to different parts of the body.
Patients who have had a different cancer treatment within the last 4 weeks.
Patients with serious heart problems.
Patients with uncontrolled high blood pressure.
Patients with severe liver disease.
Patients with severe kidney disease.
Patients who are pregnant or breastfeeding.
Patients who have an active infection that needs treatment.
Patients who have a history of allergic reactions to the study drugs.
Patients who are unable to follow the study procedures.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Hospital Universitario De Navarra	Pamplona	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium
Aix Marseille University	Marseille	France

Other Sites

Site Name	City	Country
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Italy
Centre hospitalier universitaire de Liege	Liege	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Santa Maria Della Misericordia	Perugia	Italy
Klinikum Wels-Grieskirchen GmbH	Wels	Austria
Grand Hopital De Charleroi	Charleroi	Belgium
Algemeen Ziekenhuis Groeninge	Kortrijk	Belgium
Hospital Universitario De Jaen	Jaen	Spain
Hopital De Libramont	Libramont-Chevigny	Belgium
MD Anderson Cancer Center	Madrid	Spain
Krankenhaus Der Barmherzigen Brueder Wien	Vienna	Austria
Landesklinikum Wiener Neustadt	Vienna	Austria
Hestia Duran I Reynals	L'hospitalet De Llobregat	Spain
Landeskrankenanstalten-Betriebsgesellschaft Kabeg	Klagenfurt am Wörthersee	Austria
Virgen del Rocío University Hospital	Sevilla	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Universita’ Degli Studi Di Verona	Verona	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH	Feldkirch	Austria
Hospital Universitario De Cruces	Barakaldo	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Universita’ Di Pisa	Pisa	Italy
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Kepler Universitaetsklinikum GmbH	Linz	Austria
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
CHU Helora	La Louviere	Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
MVZ Nordoberpfalz GmbH	Weiden I.D.Opf.	Germany
CHU de Toulouse – Hôpital Pierre-Paul Riquet	Toulouse	France
Centre Francois Baclesse	Caen	France
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Universitätsklinikum St. Pölten	St. Poelten	Austria
Cghccpsbr Umcadjojruxskf Sgphrwkxx	Woluwe-Saint-Lambert	Belgium
Hqfujyis Umzlhyhoyhzpx Mssuhjg Dq Vxtnnzusvz	Santander	Spain
Hhnfvjzz Uazkioufpbhdy Dr Bxulwrc	Badajoz	Spain
Iggfhk	Bonheiden	Belgium
Otdearofitpjqnqoviqdtnqbrq	Aalst	Belgium
Ieqmmkir Rgprcntpk Phg Lx Sjifvj Dvf Twamej Dmbh Ajspbwh Igfb Smqins	Meldola	Italy
Biveeqls Uhaozurene Htlvszic Cnccmn	Besançon	France
Aljtjlz Uur Iiscu Dx Rhnsuo Ecghkj	Reggio Emilia	Italy
Hrfnqgqj Dw Ld Sjwyk Czzb I Sjsk Pvu	Barcelona	Spain
Fdbtwdpid Pfhj Ll Ihyxlqckekqqi Buyduvagx Dfd Hdurmejb Ugvzcczrrdirz Lw Pji	Madrid	Spain
Hfiahvjd Uaaysrdmswdlv Hdyavzzk Tjxqz y Pruqky Idsfaylz Cfmrhd dawmvidpbvsqyimrh (owgq	Badalona	Spain
Lxanssqjtmezrakfs Skfbbdew	Salzburg	Austria
Hcscthmk Vqew debuwzrw	Barcelona	Spain
Kjpkbfi Dcs Bsfzevtqslzn Bqpyfyr	Linz	Austria

Trial status

Country	Status	Recruitment Start
Austria	Not recruiting	01.03.2022
Belgium	Not recruiting	01.03.2022
France	Not recruiting	01.03.2022
Germany	Not recruiting	01.03.2022
Italy	Not recruiting	01.03.2022
Spain	Not recruiting	01.03.2022

Trial locations

Investigated drugs:

Nab-Paclitaxel is a medication used in cancer treatment. It is a form of chemotherapy that helps to stop the growth of cancer cells by interfering with their ability to divide and multiply. In this trial, it is used to treat patients with metastatic pancreatic ductal adenocarcinoma.

Gemcitabine is another chemotherapy drug used in this study. It works by slowing or stopping the growth of cancer cells. It is often used in combination with other medications to enhance its effectiveness in treating pancreatic cancer.

SBP-101 is an investigational drug being tested in this trial. It is being studied to see if it can improve the overall survival of patients with metastatic pancreatic ductal adenocarcinoma when used alongside nab-paclitaxel and gemcitabine.

Investigated diseases:

Ductal adenocarcinoma of pancreas

Metastatic Pancreatic Ductal Adenocarcinoma – This is a type of cancer that begins in the ducts of the pancreas and has spread to other parts of the body. It is characterized by the uncontrolled growth of cells in the pancreatic ducts, which are responsible for transporting digestive enzymes. As the disease progresses, it can invade nearby tissues and organs, leading to further complications. The spread of cancer cells to distant organs, such as the liver or lungs, is a hallmark of its metastatic nature. Symptoms may include abdominal pain, weight loss, and jaundice, among others. The progression of the disease can vary, but it typically involves increasing severity of symptoms and further spread of cancer cells.

Trial ID:

2024-514714-12-00

Protocol code:

CL-SBP-101-04

NCT ID:

NCT05254171

Trial Phase:

Therapeutic use (Phase IV)

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Study of SBP-101, Nab-Paclitaxel, and Gemcitabine for Patients with Metastatic Pancreatic Cancer

What is this study about?

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