Phase II Trial of Vemurafenib and Sorafenib in Pancreatic Cancer

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    12
  • sponsor
    HonorHealth Research Institute
Updated on 12 November 2021
BRAF
KRAS
cancer chemotherapy

Summary

The purpose of this research is to determine the benefit of two oral chemotherapy drugs, Vemurafenib and Sorafenib, in individuals with KRAS G12D mutated pancreatic cancer who have progressed on standard chemotherapy.

Details
Condition cancer, pancreatic, cancer of the pancreas, Islet Ce417ll Cancer, pancreatic cancers, Pancreatic Cancer
Treatment Sorafenib, Vemurafenib
Clinical Study IdentifierNCT05068752
SponsorHonorHealth Research Institute
Last Modified on12 November 2021

Eligibility

Yes No Not Sure

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 G12D 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
Not a woman of childbearing potential (WOCBP) OR
A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 30 days after the last dose of trial treatment
Male participants must agree to use contraception during the treatment period and for at least 30 days after the last dose of trial treatment and refrain from donating sperm during this period
Patient must have QTC of 500ms
Subject must be able to swallow and retain oral medication

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 breast 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
Active of clinically significant cardiac disease
Has history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Has an active infection requiring systemic therapy
Evidence or history of bleeding diathesis or coagulopathy
Patient with any pulmonary hemorrhage/bleeding event of NCI-CTCAE v5.0 Grade 2 within 4 weeks before initiating study treatment; any other hemorrhage/bleeding event of NCI-CTCAE v5.0 Grade 3 within 4 weeks before initiating study treatment
Patient with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) within 6 months of informed consent
Presence of a non-healing wound, non-healing ulcer, or bone fracture
History of organ allograft (including corneal transplant)
Known or suspected allergy or hypersensitivity to any of the study drugs (sorafenib, and or vemurafenib) study drug classes, or excipients of the formulations given during the course of this trial
All patients with known diagnosis of Neurofibromatosis Type 1 or other known RAS-opathies
Patients with uncontrolled seizures
Treatment with medications that have known risk of QTc interval prolongation or Torsades de Pointe (TdP) within 14 days before dose of either drug is given in this study and for the duration of the study. Refer to Appendix F
Treatment with a strong or moderate CYP3A inducers (e.g, phenytoin, carbamazepine, phenobarbital, St. John's Wort [hypericum perforatum], dexamethasone at a dose of greater than 16 mg daily, or rifampin [rifampicin], and/or rifabutin) or inhibitors within 28 days before dose of either drug is given in this study and for the duration of the study. Refer to Appendix G
Treatment with medications that are major CYP1A2 substrates within 14 days before dose of either drug is given in this study and for the duration of the study. Refer to Appendix H
Malabsorption or other significant bowel or stomach resections
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Inability to comply with the protocol and/or not willing or not available for follow-up assessments required to assess toxicity
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