The REPEAT trial: Regorafenib in combination with Paclitaxel in advanced oesophagogastric carcinoma, a phase 1b study

Phase 2

Completed

• Conditions: oesophageal cancer; oesophagogastric cancer; 10017991

• Registration Number: NL-OMON47541
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

* Patient must understand, be willing to give consent, and sign a written
informed consent form prior to undergoing any study-specific procedure
* Male or female and * 18 years of age
* Metastastic or non-resectable adeno- or squamous-cell carcinoma of the
stomach or oesophagus who failed on first line cytotoxic treatment with a
fluoropyrimidine and platinum compound
* Tumor accessible for repeated biopsies (expansion cohort only)
* Measurable disease
* Life expectancy of at least 12 weeks
* Eastern Cooperative Oncology Group performance status of 0 or 1 (within14
days prior to the initiation of study treatment)
* Have adequate bone marrow, liver function, and renal function

Exclusion Criteria

* Prior treatment with regorafenib
* Contra-indications for repeated biopsies
* Dementia or altered mental status that would prohibit the understanding and
giving of informed consent
* Have unresolved toxicity higher than National Cancer Institute-Common
Terminology for Adverse Events version 4.0 (NCI-CTCAE v 4.0) Grade 1 attributed
to any prior therapy/procedure, excluding alopecia.
* Have had a major surgical procedure, open biopsy, or significant traumatic
injury within 28 days prior to initiation of study treatment
*
* Have currently suspected brain metastases

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Toxicity</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Paclitaxel concentration in tumor biopsy<br /><br>* Paclitaxel pharmacokinetics<br /><br>* Expression of regorafenib targets in tumor biopsy samples<br /><br>* Progression free survival<br /><br>* Overall survival</p><br>