A clinical study of TG6002 and flucytosine in patients with colorectal cancer

Phase 1

• Conditions: Colorectal cancer; MedDRA version: 21.0Level: PTClassification code 10052358Term: Colorectal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004103-39-FR
• Lead Sponsor: TRANSGENE S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-08
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Histological or cytological diagnosis of colorectal cancer.
2. Unresectable metastatic colorectal cancer with at least one measurable liver metastasis.
3. At least one liver metastasis amenable to biopsy.
4. Patients previously exposed to fluoropyrimidine-based chemotherapy.
5. (Phase I) Patients having failed, are intolerant to, or unsuitable for both oxaliplatin and irinotecan-based chemotherapy, or patients on or entering a period of clinical observation without treatment.
6. (Phase IIa) Patients having failed, are intolerant to, or unsuitable for both oxaliplatin and irinotecan-based chemotherapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Predominant extrahepatic disease.
2. Symptomatic brain metastases or meningeal tumors.
3. Documented occlusion of the hepatic artery or main portal vein.
4. Reverse portal vein flow on ultrasound sonography.
5. Any contraindication to intrahepatic artery infusion procedure including portosystemic shunt, and artery occlusive disease (ceoliac trunk and/or superior mesenteric artery), if it may inhibit catheterization of the hepatic artery.
6. History of severe exfoliative skin condition (e.g. eczema or atopic dermatitis) requiring systemic therapy for more than 4 weeks within 2 years prior to TG6002 treatment initiation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified