E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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) |
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E.1.1.1 | Medical condition in easily understood language |
Patients with a solid tumor treated previously with regorafenib (monotherapy or combination treatment) are eligible. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038407 |
E.1.2 | Term | Renal cell cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10062427 |
E.1.2 | Term | Gastrointestinal stromal tumor |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052362 |
E.1.2 | Term | Metastatic colorectal cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10073071 |
E.1.2 | Term | Hepatocellular carcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- The primary purpose of the program is to enable participants, currently receiving regorafenib in a Bayer-sponsored clinical trial and assessed by the principal investigator (PI) to be benefitting, to continue regorafenib treatment after their respective study has met its primary completion endpoint, or main data analysis, or has been stopped prematurely
- And the documentation of safety |
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E.2.2 | Secondary objectives of the trial |
Documentation of tolerability |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Frequency and severity of SAEs and protocol-specified AEs |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
All safety analysis will be done in a descriptive manner only at the end of a study |
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E.5.2 | Secondary end point(s) |
Frequency of dose modifications |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Tolerability of study drug will be evaluated by displaying the number of dose modifications in frequency tables at the end of study. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
China |
France |
Germany |
Italy |
Japan |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is defined as the date when the last participant has completed the study and the sponsor has decided to close enrollment. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 8 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 8 |