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Galunisertib Combined With Capecitabine in Advanced CRC With PM

ConditionsColorectal Cancer MetastaticPeritoneal Carcinomatosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute

About this trial

This is a two-center open-label non-randomized proof of principle study consisting of a dose-finding part (phase I) and phase II study with Simon two-stage design investigating the anti-tumor activity of the combination of capecitabine and galunisertib in patients with colorectal cancer with peritoneal metastases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histological or cytological proof of CRC with at least confirmed peritoneal metastases (presence of additional extraperitoneal metastases is allowed);

Disease progression or relapse upon treatment for advanced CRC with fluoropyrimidine containing chemotherapy as single agent or in combination with other anti-cancer drugs, with no treatment options at time of inclusion (combinations with oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab are allowed);

Age ≥ 18 years;

Able and willing to give written informed consent and informed consent form must have been signed before start of the trial;

Disqualifiers

Any treatment with investigational drugs within 30 days prior to receiving the first dose of investigational treatment and/or radio- or chemotherapy within the last 2 weeks prior to receiving the first dose of investigational treatment. Palliative radiation (1x 8Gy) is allowed; except radiotherapy focused on the liver;

Known or suspected complete or partial dihydropyrimidine dehydrogenase deficiency (Mutant for DPD*2A genotype, 1236G>A genotype, 1679T>G genotype and 2846A>T genotype);

Symptomatic or untreated leptomeningeal disease;

Symptomatic brain metastasis. Patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid therapy are allowed to enrol. Brain metastasis must be stable with verification by imaging (e.g.

Trial design

Design model

Single group

Treatments tested in this trial

  • Galunisertib plus capecitabine

    Drug

    Combination therapy with galunisertib plus capecitabine

Treatment groups

31 Participants
are divided into 1 treatment group
Group A: Galunisertib plus capecitabineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with treatment-related adverse events according to CTCAE v5.0, dose limiting toxicities

To determine the safety and RP2D of galunisertib plus capecitabine in patients with advanced chemotherapy resistant CRC with peritoneal metastases

Time frame
28 days
2

Objective response rate (ORR)

To determine the anti-tumor activity as measured by ORR of galunisertib plus capecitabine in patients with advanced chemotherapy resistant CRC with PM.

Time frame
through study completion, an average of 6 months per patient

Secondary outcomes

1

Duration of response (DOR)

Time from first response until progression

Time frame
through study completion, an average of 6 months per patient
2

Time to response (TTR)

Time from start of treatment until first objective response

Time frame
From date of study entry until first objective response, an average of 2 months
3

Progression free survival (PFS)

Time from start of the treatment until progression

Time frame
From date of study entry until the date of first documented progression of date of death from any cause, whichever comes first, assessed up to 5 years
4

Overall survival (OS)

Time from start of the study until death

Time frame
From date of study entry until date of death from any cause, assessed up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Netherlands Cancer Institute

Lead sponsor

Amsterdam UMC

Collaborator

Source ClinicalTrials.gov
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