Safety, Pharmacokinetics and Anti-tumor Activity of RP12146, a PARP Inhibitor, in Patients With Locally Advanced or Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT05002868|
Recruitment Status : Recruiting
First Posted : August 12, 2021
Last Update Posted : June 9, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Extensive-stage Small-cell Lung Cancer Locally Advanced Breast Cancer Metastatic Breast Cancer Platinum-sensitive Ovarian Cancer Platinum-Sensitive Fallopian Tube Carcinoma Platinum-Sensitive Peritoneal Cancer||Drug: RP12146||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||October 5, 2021|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||August 2023|
RP12146 will be administered orally daily (QD or BID)
starting dose of 100 mg QD
- Maximum tolerated dose (MTD) of RP12146 in patients with locally advanced or metastatic solid tumors [ Time Frame: 28 days ]The MTD was defined as the highest dose level at which no more than 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment
- Number of Participants With Treatment-emergent Adverse Events as Assessed by CTCAE Criteria v5.0 [ Time Frame: 2 years ]Summary of Treatment-Emergent Adverse Events-(Causality All). Patients will be monitored for adverse events and both related and as well as non-related adverse events will be captured during the study. All adverse events (irrespective of causality) will be reported.
- Tmax [ Time Frame: Day 1 to Day 28 ]Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of RP12146
- Cmax [ Time Frame: Day 1 to Day 28 ]Pharmacokinetics: Maximum Concentration (Cmax) of RP12146
- AUC [ Time Frame: Day 1 to Day 28 ]Pharmacokinetics: Area Under the Concentration Curve (AUC) of RP12146
- Overall response rate (ORR) [ Time Frame: 2 years ]Sum of the percentages of Complete Response and Partial Response
- Clinical benefit rate (CBR) [ Time Frame: 2 years ]Sum of the percentages of Complete response, partial response and stable disease
- Progression free survival (PFS) [ Time Frame: 2 years ]It is defined as time from the first dose of study treatment to documented disease progression
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- Patients with HER2 positive breast cancer
- 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.
- Patient with symptomatic uncontrolled brain metastasis.
- Pregnancy and lactation
- Patients with uncontrolled disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05002868
|Contact: Prajak I Barde, MDemail@example.com|
|Hořovice, Czechia, 268 31|
|Contact: Martin Šamakal, MD|
|FN Olomouc, Oncology clinic,||Recruiting|
|Olomouc, Czechia, 779 00|
|Contact: Prof. MUDr. Bohuslav Melichar|
|Pratia Poznań Medical Center||Recruiting|
|Clinical Trials Site Nasz Lekarz||Recruiting|
|Contact: Dominik Chraniuk|
|Maria Skłodowska-Curie Memorial National Oncology Institute||Recruiting|
|Contact: Prof. Lugowska|
|Klinika Onkologii ICZMP||Recruiting|
|Łódź, Poland, 93-338|
|Contact: Prof. Ewa Kalinka|
|Responsible Party:||Rhizen Pharmaceuticals SA|
|Other Study ID Numbers:||
|First Posted:||August 12, 2021 Key Record Dates|
|Last Update Posted:||June 9, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Small Cell Lung Carcinoma
Neoplasms by Site
Respiratory Tract Neoplasms
Respiratory Tract Diseases
Immune System Diseases