NCT05002868CompletedPhase 1
Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, in Patients With Solid Tumors
A Multi-center, Open-label, Phase I/Ib Study to Assess the Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, a Poly (ADP-ribose) Polymerase (PARP) Inhibitor, in Patients With Locally Advanced or Metastatic Solid Tumors
Source: ClinicalTrials.gov · Last updated 19 Sept 2024
Brief summary (registry, in English)
An open-label, two-part Phase I/Ib study of RP12146 in adult patients with locally advanced or metastatic solid tumors. The first part (Part 1) is a Phase I dose-escalation, 3+3 design, open-label, MTD determination study and will enroll patients who have tumors known to harbour DNA repair deficiencies. The second part (Part 2) is a Phase Ib, dose-expansion at the MTD (or optimal dose) and will enroll patients with a confirmed deleterious HRR mutation in their tumor as identified by a central genomics testing laboratory.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 5 Aug 2021
- Start date
- 5 Oct 2021
- Primary completion date
- 25 Apr 2024
- Lead sponsor
- Rhizen Pharmaceuticals SA
- NCT number
- NCT05002868
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 23
- From 5 Oct 2021 to the primary completion date, 25 Apr 2024
- 6 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving anticancer therapy
- Patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia.
- Prior treatment with a PARP inhibitor
- Major surgery within 4 weeks of starting study treatment or any patient who has not recovered from the effects of major surgery.
Other illness
- Patients with HER2 positive breast cancer
- Patients with uncontrolled disease
Other
- Patient with symptomatic uncontrolled brain metastasis.
- Pregnancy and lactation
Who the study is looking for
- Provision of full informed consent prior to any study-specific procedures.
- Patients must be ≥18 years of age, at the time of signing informed consent.
- Dose escalation phase, patients with histologically and/or cytologically confirmed malignant solid tumor whose disease has progressed following at least one standard therapy and who have no other acceptable standard treatment options. Tumor types will include breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small cell lung cancer (ES-SCLC), prostate, pancreatic, colorectal gastric, biliary tract, and endometrial cancer.
- Dose-expansion phase patients with histologically and/or cytologically confirmed malignant solid tumor (breast, ovarian, fallopian tube, or peritoneal cancer, extensive-stage small cell lung cancer (ES-SCLC), with one of the documented deleterious mutations of specified HRR genes and whose disease has progressed following at least one standard therapy.
- Patients with at least one measurable lesion per RECIST version 1.1 at baseline that can be accurately assessed by CT-scan or MRI and is suitable for repeated assessment at follow up-visits.
- ECOG performance status 0 to 2.
- Use of contraception measures
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Multiscan s.r.o. Coordinator of this site? Confirm its status | Hořovice | Czechia | Unknown status |
| SP ZOZ University Hospital in Krakow Oncology Clinic, 50 Kopernika Street Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Klinika Onkologii ICZMP Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Pratia Poznań Medical Center Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Clinical Trials Site Nasz Lekarz Coordinator of this site? Confirm its status | Torun | Poland | Unknown status |
| Maria Skłodowska-Curie Memorial National Oncology Institute Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.