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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 : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Rhizen Pharmaceuticals SA

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : August 2023


Arm Intervention/treatment
Experimental: RP12146
RP12146 will be administered orally daily (QD or BID)
Drug: RP12146
starting dose of 100 mg QD




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Tmax [ Time Frame: Day 1 to Day 28 ]
    Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of RP12146

  2. Cmax [ Time Frame: Day 1 to Day 28 ]
    Pharmacokinetics: Maximum Concentration (Cmax) of RP12146

  3. AUC [ Time Frame: Day 1 to Day 28 ]
    Pharmacokinetics: Area Under the Concentration Curve (AUC) of RP12146

  4. Overall response rate (ORR) [ Time Frame: 2 years ]
    Sum of the percentages of Complete Response and Partial Response

  5. Clinical benefit rate (CBR) [ Time Frame: 2 years ]
    Sum of the percentages of Complete response, partial response and stable disease

  6. Progression free survival (PFS) [ Time Frame: 2 years ]
    It is defined as time from the first dose of study treatment to documented disease progression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria.

  1. Provision of full informed consent prior to any study-specific procedures.
  2. Patients must be ≥18 years of age, at the time of signing informed consent.
  3. 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.
  4. 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.
  5. 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.
  6. ECOG performance status 0 to 2.
  7. Use of contraception measures

Exclusion Criteria:

  1. Patients with HER2 positive breast cancer
  2. Patients receiving anticancer therapy
  3. Patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia.
  4. Prior treatment with a PARP inhibitor
  5. Major surgery within 4 weeks of starting study treatment or any patient who has not recovered from the effects of major surgery.
  6. Patient with symptomatic uncontrolled brain metastasis.
  7. Pregnancy and lactation
  8. Patients with uncontrolled disease

Information from the National Library of Medicine

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


Contacts
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Contact: Prajak I Barde, MD +41325800175 pjb@rhizen.com

Locations
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Poland
Pratia Poznań Medical Center Recruiting
Poznań, Poland
Contact: Dr.Tomczak         
Clinical Trials Site Nasz Lekarz Recruiting
Toruń, Poland
Contact: Dominik Chraniuk         
Maria Skłodowska-Curie Memorial National Oncology Institute Recruiting
Warszawa, Poland
Contact: Prof. Lugowska         
Sponsors and Collaborators
Rhizen Pharmaceuticals SA
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Responsible Party: Rhizen Pharmaceuticals SA
ClinicalTrials.gov Identifier: NCT05002868    
Other Study ID Numbers: RP12146-2101
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Rhizen Pharmaceuticals SA:
PARP
Additional relevant MeSH terms:
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Breast Neoplasms
Small Cell Lung Carcinoma
Hypersensitivity
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Immune System Diseases