Phase II Trial of Vemurafenib and Sorafenib in Pancreatic Cancer (NCT05068752) | Clinical Trial Compass
CompletedPhase 2
Phase II Trial of Vemurafenib and Sorafenib in Pancreatic Cancer
United States10 participantsStarted 2021-10-28
Plain-language summary
The purpose of this research is to determine the benefit of two oral chemotherapy drugs, Vemurafenib and Sorafenib, in individuals with KRAS mutated pancreatic cancer who have progressed on standard chemotherapy.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. Be able to understand and be willing to sign the written informed consent for the trial. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
✓. Be ≥ 18 years of age on day of signing informed consent.
✓. Histologically confirmed cancer of the pancreas (KRAS mutated) with metastases and progression on at least ≥ 2 prior treatment regimens for their disease.
✓. Known mutation status of KRAS and BRAF kinases. For those patients in which this has not previously been determined, the patient must have an archival tumor specimen (primary or metastatic site) available to submit to confirm KRAS and BRAF status.
✓. Have a performance status of 0 or 1 on the ECOG performance scale.
✓. Demonstrate adequate organ function
✓. Female participants of childbearing potential must have a negative serum pregnancy test performed within 24 hours prior to receiving first dose of trial medication. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
✓. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Exclusion criteria
✕. Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 2 weeks of the first dose of this trials' treatment.
✕. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Cycle 1/Day 1 or who has not recovered (i.e. NCI-CTC AE Version 5.0 ≤ Grade 1 at the time of signing informed consent) from adverse events due to a previously administered agent(s).
✕. Previous BRAF inhibitor use such as vemurafenib, GSK2118436 or sorafenib.
✕. If patient received major surgery, and has not yet recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
✕. Previously untreated or concurrent cancer that is distinct in primary site or histology from pancreatic cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Subjects surviving a cancer that was curatively treated and without evidence of disease for more than 3 years before study entry. All cancer treatments must be completed at least 3 years prior to study entry (i.e., signature date of the informed consent form).
✕. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
✕. Uncontrolled hypertension (systolic pressure \>140 mm Hg or diastolic pressure \> 90 mm Hg \[NCI-CTCAE v5.0\] on repeated measurement) despite optimal medical management.
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What they're measuring
1
Disease Control Rate (DCR)
Timeframe: Initiation of study treatment until 16 weeks.