Regorafenib rollover study

Phase 1

• Conditions: 1. metastatic or unresectable renal cell cancer (RCC) 2. metastatic and/or unresectable gastrointestinal stromal tumors (GIST) 3. metastatic colorectal cancer (CRC) 4. hepatocellular carcinoma (HCC); MedDRA version: 20.0 Level: LLT Classification code 10038407 Term: Renal cell cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10062427 Term: Gastrointestinal stromal tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10073071 Term: Hepatocellular carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-003650-24-GB
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-12
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

Age
1. Participant must be age-eligible in the feeder study at the time of signing the informed consent.

Type of Participant and Disease Characteristics
2. Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving study treatment.
3. Participant is currently benefiting from treatment with regorafenib monotherapy and meets criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder protocol.
4. Any ongoing adverse events that require temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption by the investigator.

Sex
5. Male or female
Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. This applies for the time between signing of the informed consent form and 2 months after the last administration of the study intervention.

Male participants:
In addition to the above methods, male trial participants and male partners of female trial participants must also use condoms during sex as an extra measure of protection against pregnancy.

Female participants:
The investigator or a designated associate is requested to advise sexually active participants on how to achieve highly effective birth control using one or more of the following methods:
• Hormonal contraception associated with inhibition of ovulation containing both estrogen and progestogen (oral, intravaginal or transdermal)
• Hormonal contraception associated with inhibition of ovulation containing only progestogen (oral, injectable or implantable)
• Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion
• Vasectomized partner (provided that partner is the sole sexual partner of the woman of childbearing potential who is the trial participant and that the vasectomized partner has received medical assessment of surgical success)
Women not considered to be of childbearing potential include those who biologically sterile, permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) or postmenopausal. Postmenopausal women are defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.

Informed Consent
6. Capable of giving signed informed consent as described in Appendix 1 (Section 10.1) which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
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 10

Exclusion Criteria

Medical Conditions
1. Ineligibility, for medical reasons, to start the next cycle in the respective feeder study
2. Patients with a beta-hCG test consistent with pregnancy.

Prior/Concomitant Therapy
3. Participants are using one or more of the prohibited medications listed in the respective feeder study protocol. A comprehensive list can be found in Section 6.4.

Prior/Concurrent Clinical Study Experience
4. Participant has been previously permanently discontinued from regorafenib treatment.

Diagnostic assessments
Not Applicable for this study.

Other Exclusions
5. Participant is unable to comply with the requirements of the study.

Study & Design

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