CompletedPhase 2

Single Agent Regorafenib in First-line for Metastatic/Unresectable KIT/PDGFR Wild Type GIST

France, Italy15 participantsStarted 2015-11

Plain-language summary

Evaluate the treatment with regorafenib in patients with metastatic and/or unresectable KIT/PDGFR wild type GIST in the first line setting.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
✓. Male or female subjects ≥18 years of age
✓. Histologically confirmed GIST KIT/PDGFR wild-type, unresectable or metastatic GIST (confirmed by central laboratory). Paraffin-embedded tumor block must be provided by all subjects during screening period.
✓. Screening of mutations done in exon 11, 9, 13 and 17 in KIT gene and in 12 and 18 exons of PDGFR gene
✓. Subjects must have at least one measurable lesion according to RECIST v1.1 criteria. A lesion in a previously irradiated area is eligible to be considered as measurable disease as long as there is objective evidence of progression of the lesion prior to study enrolment.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
✓. Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment:
✓. Women of childbearing potential and men must agree to use adequate contraception from the moment of signing the Informed Consent Form until at least 3 months after the last study drug administration. The investigator or a designated associate is requested to advise the subject on how to achieve an adequate birth control. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) as per standard of care.

Exclusion criteria

✕. Prior systemic treatment for GIST BESIDES IMATINIB. Patients that have relapsed after receiving imatinib during adjuvant setting and patients who are on treatment or have been treated with Imatinib as first line of advanced KIT/PDGFRa wild type GIST are eligible.
✕. Cancer other than GIST within 5 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, and superficial bladder tumors (Ta (Non Invasive tumor), and Tis (Carcinoma In situ)).
✕. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before the start of study medication.
✕. Congestive Heart Failure New York Heart Association (NYHA) ≥ class 2.
✕. Unstable angina (angina symptoms at rest, new-onset angina, ie, within the lasts 3 months prior to entering study) or myocardial infarction (MI) within the past 6 months before the start of study medication.
✕. Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
✕. Uncontrolled hypertension (Systolic blood pressure \> 140 mmHg or diastolic pressure \> 90mmHg despite optimal medical management).
✕. Subjects with pheochromocytoma.

What they're measuring

Disease Control Rate

Timeframe: every 8 weeks during 36 months

Trial details

NCT IDNCT02638766

SponsorGrupo Espanol de Investigacion en Sarcomas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-31

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