Ended Phase I and Phase II (Integrated)- Other colorectal cancer

Phase I/II study with galunisertib combined with capecitabine in patients with advanced chemotherapy resistant colorectal cancer with peritoneal metastases

EU CTIS ID: 2024-518980-37-00

What this study is testing

With this clinical study, we aim to gain more information about the pharmacological characteristics, safety profile, tolerability and efficacy of galunisertib in combination with capecitabine in patients with PM from CRC

Phase I and Phase II (Integrated)- Other

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Histological or cytological proof of CRC with at least confirmed peritoneal metastases (presence of additionalextraperitoneal metastases is allowed);
10. Minimal acceptable safety laboratory values a. ANC of ≥1.5 x 109 /L b. Platelet count of ≥100 x 109 /L c. Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 3.0 x ULN, or ALAT and ASAT < 5x ULN in patients with liver metastases d. Renal function as defined by serum creatinine ≤ 1.5 x ULN e. Creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula or MDRD);
11. Negative pregnancy test (urine or serum) for female patients with childbearing poten-tial.
12. Able and willing to swallow tablets.
2. Disease progression or relapse upon treatment for advanced CRC with fluoropyrimidine containingchemotherapy as single agent or in combination with other anti-cancer drugs, with no treatment options at time ofinclusion
3. Age ≥ 18 years;

You likely can't join if

1. Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigationaltreatment and/or radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigationaltreatment. Palliative radia-tion (1x 8Gy) is allowed; except radiotherapy focused on the liver;
10. Active infection requiring systemic antibiotics or uncontrolled infectious disease;
11. Patients with a known history of hepatitis B or C or known Human Immunodeficiency Virus HIV-1 or HIV-2 typepatients;
12. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnor-mality that may increasethe risk associated with study participation or study drug administration or that may interfere with the interpretationof study results and, in the judgment of the investigator, would make the patient inappropriate for the study;
13. Known hypersensitivity to one of the study drugs or excipients.
2. Known or suspected complete or partial dihydropyrimidine dehydrogenase deficien-cy (Mutant for DPD*2Agenotype, 1236G>A genotype, 1679T>G genotype and 2846A>T genotype);

See the full eligibility criteria

Who can join

1. Histological or cytological proof of CRC with at least confirmed peritoneal metastases (presence of additionalextraperitoneal metastases is allowed);
10. Minimal acceptable safety laboratory values a. ANC of ≥1.5 x 109 /L b. Platelet count of ≥100 x 109 /L c. Hepatic function as defined by serum bilirubin ≤ 1.5 x ULN, ALAT and ASAT ≤ 3.0 x ULN, or ALAT and ASAT < 5x ULN in patients with liver metastases d. Renal function as defined by serum creatinine ≤ 1.5 x ULN e. Creatinine clearance ≥ 50 ml/min (by Cockcroft-Gault formula or MDRD);
11. Negative pregnancy test (urine or serum) for female patients with childbearing poten-tial.
12. Able and willing to swallow tablets.
2. Disease progression or relapse upon treatment for advanced CRC with fluoropyrimidine containingchemotherapy as single agent or in combination with other anti-cancer drugs, with no treatment options at time ofinclusion
3. Age ≥ 18 years;
4. Able and willing to give written informed consent and informed consent form must have been signed before startof the trial;
5. WHO performance status of ≤1;
6. Able and willing to undergo blood sampling for PK analysis;
7. Able and willing to undergo tumor biopsy before start, during treatment and at the end of treatment;
8. Life expectancy > 3 months allowing adequate follow up of toxicity and anti-tumor activity;
9. Evaluable disease according to RECIST 1.1 criteria

What rules you out

1. Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigationaltreatment and/or radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigationaltreatment. Palliative radia-tion (1x 8Gy) is allowed; except radiotherapy focused on the liver;
10. Active infection requiring systemic antibiotics or uncontrolled infectious disease;
11. Patients with a known history of hepatitis B or C or known Human Immunodeficiency Virus HIV-1 or HIV-2 typepatients;
12. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnor-mality that may increasethe risk associated with study participation or study drug administration or that may interfere with the interpretationof study results and, in the judgment of the investigator, would make the patient inappropriate for the study;
13. Known hypersensitivity to one of the study drugs or excipients.
2. Known or suspected complete or partial dihydropyrimidine dehydrogenase deficien-cy (Mutant for DPD*2Agenotype, 1236G>A genotype, 1679T>G genotype and 2846A>T genotype);
3. Symptomatic or untreated leptomeningeal disease;
4. Symptomatic brain metastasis.
5. History of cardiac disease, including myocardial infarction within 6 months before first dose of study medication,unstable angina pectoris, New York Heart Associa-tion Class III/IV congestive heart failure, or uncontrolledhypertension, major cardiac abnormalities, a predisposition for developing aneurysms including family history ofaneurysms, Marfan syndrome, bicuspid aortic valve, or evidence of damage to the large vessels of the heart;
6. Treatment with CYP3A4 inducers or inhibitors and/or concomitant treatment with CYP2C9 substrates withnarrow therapeutic window, including but not limited to vit-amin K antagonizing anticoagulants (e.g.acenocoumarol, phenprocoumon and war-farin) and phenytoin is not allowed;
7. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oralgalunisertib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, majorsmall bowel surgery);
8. Woman who are pregnant or breast feeding;
9. Patients who have undergone any major surgery within the last 2 weeks prior to starting study drug or whowould not have fully recovered from previous surgery;

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.