Clinical Trial TitleTMPS-101: A Single-Arm Phase-II Study of Niraparib in Locally Advanced or Metastatic Solid Tumor Patients with PALB2 Mutations
National Clinical Trial Number:NCT05169437
Clinical Trial Protocol Description:
This is a multicenter study of Niraparib in participants with locally advanced or metastatic solid tumors and a confirmed pathogenic or likely pathogenic tPALB2 mutation. Participants must have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the Investigator, the patient would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy, or the participant has no satisfactory alternative treatments.
Subjects will either receive a starting dose of niraparib 300 mg (three 100-mg tablets) or 200 mg (two 100-mg tablets) based on body weight and platelet count. Niraparib will be taken orally once daily throughout each 28-day cycle until a study treatment discontinuation criterion is met.
Niraparib is an investigational drug that is being studied by Tempus (“Sponsor”) for use in the treatment of locally advanced or metastatic (spreading) solid tumors. “Investigational” means that Niraparib has not been approved by the US Food and Drug Administration (“FDA”) as a prescription or over-the-counter medication for use in this way.
Niraparib is marketed as ZEJULA® by the pharmaceutical company GlaxoSmithKline (“GSK”) (previously Tesaro) and is approved to treat adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal (the tissue that lines the abdomen) cancer in the United States by the U.S. Food and Drug Administration (FDA) and in Europe (by the European Regulatory Authority, European Medicines Agency (EMA)). It has not been approved by the FDA or any regulatory authority to treat locally advanced or metastatic solid tumors with a tumor PALB2 mutation.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are at least 18 years of age or older.
- Have confirmed diagnosis of locally advanced or metastatic solid tumor(s).
- Have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the Investigator, the patient would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy, or the participant has no satisfactory alternative treatments.
You will be excluded from the study if any of the following criteria apply to you:
- Have other active medical condition that warrants systemic, biologic, or hormonal therapy.
- Have ovarian or prostate cancer.
- Have relapsed while receiving platinum based therapy in the adjuvant/curative setting.
- Are progressing within 14-18 weeks while receiving platinum based therapy in the metastatic setting
- Have systolic blood pressure (BP) over 140 mmHg or diastolic BP over 90 mmHg, despite optimal medical therapy.
- Have previously or are currently participating in a treatment study of an investigational agent within 3 weeks of the first dose of therapy preceding the study.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.