Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy

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Brief Title

Maintenance With Niraparib In Patients With Advanced Urothelial Cancer After 1st-line Platinum-based Chemotherapy

Official Title

A Phase II, Randomized, Trial of Niraparib Versus Best Supportive Care as Maintenance Treatment In Patients With Locally Advanced Or Metastatic Urothelial Cancer Whose Disease Did Not Progress After First-line Platinum-based Chemotherapy

Brief Summary

      This is a 2-arm, prospective, randomized (2:1 ratio), open-label, multi-centre, phase II
      study conducted in patients affected by unresectable, locally advanced or metastatic
      urothelial cancer receiving niraparib plus best supportive care versus best supportive care
      as maintenance therapy after a first-line platinum-based chemotherapy.

      The primary objective of the trial is to evaluate the efficacy of niraparib plus Best
      Supportive Care (BSC) vs. BSC alone, as maintenance treatment, in terms of prolongation of
      progression-free survival (PFS), in patients with locally advanced or metastatic urothelial
      cancer that obtained disease control (objective response or stable disease) with first-line
      platinum-based chemotherapy.
    

Detailed Description

      This is a 2-arm, prospective, randomized (2:1 ratio), open-label, multi-centre, phase II
      study conducted in patients affected by unresectable, locally advanced or metastatic
      urothelial cancer receiving niraparib plus best supportive care versus best supportive care
      as maintenance therapy after a first-line platinum-based chemotherapy.

      The primary objective of the trial is to evaluate the efficacy of niraparib plus Best
      Supportive Care (BSC) vs. BSC alone, as maintenance treatment, in terms of prolongation of
      progression-free survival (PFS), in patients with locally advanced or metastatic urothelial
      cancer that obtained disease control (objective response or stable disease) with first-line
      platinum-based chemotherapy.

      Poly-adenosine diphosphate ribose polymerase (PARP) inhibitors sensitivity is based on the
      presence of truncating and missense mutations in genes associated with the homologous
      recombination pathways. In The Cancer Genome Atlas dataset approximately 34% of bladder
      urothelial carcinoma harbored these mutations. Furthermore, in this study we plan to select a
      population potentially sensible to niraparib, by enrolling patients responding to platinum,
      indeed we know that there is a cross-sensitivity and a cross-resistance between platinum
      drugs and PARP inhibitors in urothelial carcinoma.

      PFS is commonly adopted as primary endpoint in randomized phase II trials. Randomized design
      for phase II trials has been increasingly adopted in recent years, to allow a formal
      comparison between experimental and standard treatment. This should lead to a better
      interpretation of the results obtained with the experimental treatment, that are in most
      cases difficult to interpret in the absence of controls.

      The sample size of the study is calculated with "relaxed" statistical criteria. The study
      design will verify if the experimental treatment (Niraparib) is promising enough to warrant a
      phase 3 trial for efficacy compared to observation.

      A total of 65 PFS events are needed to provide 80% power to detect an hazard ratio (HR) of
      0.57 (1.75), corresponding to a median increase in progression-free survival from 4 to 7
      months, with one-tailed alpha 0.1.

      With an accrual duration of 24 months, and additional 6 months of follow up after the
      completion of recruitment, 77 patient need to be randomized (26 assigned to control arm and
      51 assigned to experimental arm) to obtain the 65 events needed.

      Sample size of the phase II trial is too small to plan a formal analysis of interaction of
      treatment efficacy with type of response at first line treatment (i.e. objective response vs.
      stable disease). However, type of response to first line treatment will be among
      stratification factor for randomization, so the 2 treatment groups will be balanced.
      Exploratory subgroup analysis of treatment efficacy in patient who have obtained objective
      response with first line and in patients who have obtained stable disease with first line
      will be performed.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression-free survival (PFS)

Secondary Outcome

 Objective response rate (ORR)

Condition

Urothelial Carcinoma

Intervention

Niraparib

Study Arms / Comparison Groups

 Experimental Arm
Description:  Patients assigned to experimental arm will receive Niraparib 300 mg or 200 mg daily (based on weight and platelet count) plus best supportive care (BSC), in 28-day cycles, until disease progression or unacceptable toxicity or death.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

58

Start Date

August 27, 2019

Completion Date

June 2024

Primary Completion Date

September 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Participant must have histologically/cytologically confirmed, unresectable locally
             advanced or metastatic transitional cell carcinoma of the urothelium (transitional
             cell carcinoma either pure or mixed histology)

          2. Measurable disease (per RECIST v1.1) prior to the start of first-line chemotherapy

          3. Prior first-line chemotherapy must have consisted of at least 4 cycles and no more
             than 6 cycles of platinum containing regimen (cisplatin or carboplatin)

          4. No evidence of progressive disease following completion of first-line chemotherapy
             (i.e., ongoing complete response (CR), partial response (PR), or stable disease (SD)
             per RECIST v1.1 guidelines )

          5. Patients must be enrolled within 4 weeks of scans demonstrating stable
             disease/partial-complete response and no more than 6 weeks after receiving the last
             standard chemotherapy dose

          6. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status
             0 or 1

          7. Participant must be ≥ 18 years of age

          8. Participant must have adequate bone marrow and organ function, defined as follows:

               -  Absolute neutrophil count ≥ 1,500/µL

               -  Platelets ≥ 100,000/µL

               -  Hemoglobin ≥ 9 g/dL

               -  Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine
                  clearance ≥ 30 mL/min using the Cockcroft-Gault equation

               -  Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR
                  direct bilirubin ≤ 1 x ULN

               -  Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver
                  metastases are present, in which case they must be ≤ 5 x ULN

          9. Participant receiving corticosteroids is eligible if their dose is stable for least 4
             weeks prior to initiating protocol therapy.

         10. Participant must agree to not donate blood during the study or for 90 days after the
             last dose of study treatment.

         11. Female participant has a negative urine or serum pregnancy test within 7 days prior to
             taking study treatment if of childbearing potential and agrees to abstain from
             activities that could result in pregnancy from screening through 180 days after the
             last dose of study treatment, or is of non-childbearing potential. Non-childbearing
             potential is defined as follows (by other than medical reasons):

               -  ≥45 years of age and has not had menses for >1 year

               -  Patients who have been amenorrhoeic for <2 years without history of a
                  hysterectomy and oophorectomy must have a follicle stimulating hormone value in
                  the postmenopausal range upon screening evaluation

               -  Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation.
                  Documented hysterectomy or oophorectomy must be confirmed with medical records of
                  the actual procedure or confirmed by an ultrasound. Tubal ligation must be
                  confirmed with medical records of the actual procedure, otherwise the patient
                  must be willing to use 2 adequate barrier methods throughout the study, starting
                  with the screening visit through 180 days after the last dose of study treatment.

             Note: Abstinence is acceptable if this is the established and preferred contraception
             for the patient.

         12. Participant must agree to not breastfeed during the study or for 180 days after the
             last dose of study treatment.

         13. Male participant agrees to use an adequate method of contraception starting with the
             first dose of study treatment through 180 days after the last dose of study treatment.
             Note: Abstinence is acceptable if this is the established and preferred contraception
             for the patient.

         14. Participant must be able to understand the study procedures and agree to participate
             in the study by providing written informed consent

         15. Blood sample availability, to determine germline BRCA mutation status

         16. Archived tumor tissue sample availability to determine homologous recombination
             deficiency (HRD) status

        Exclusion Criteria:

          1. Participant must not be simultaneously enrolled in any interventional clinical trial

          2. Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol
             therapy and participant must have recovered from any surgical effects.

          3. Participant must not have received investigational therapy ≤ 4 weeks, or within a time
             interval less than at least 5 half-lives of the investigational agent, whichever is
             shorter, prior initiating protocol therapy.

          4. Participant must not have received radiation therapy encompassing >20% of the bone
             marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of
             protocol therapy.

          5. Participant must not have a known hypersensitivity to niraparib components or
             excipients.

          6. Participant must not have been treated previously with a known PARP inhibitor agent

          7. Participant must not have received a transfusion (platelets or red blood cells) ≤ 4
             weeks prior to initiating protocol therapy.

          8. Participant must not have received colony stimulating factors (e.g., granulocyte
             colony-stimulating factor, granulocyte macrophage colony stimulating factor, or
             recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.

          9. Participant must not have experienced any known Grade 3 or 4 anemia, neutropenia or
             thrombocytopenia due to prior chemotherapy that persisted > 4 weeks.

         10. Participant must not have any known history of myelodysplastic syndrome (MDS) or acute
             myeloid leukemia (AML)

         11. Participant must not have a serious, uncontrolled medical disorder, nonmalignant
             systemic disease, or active, uncontrolled infection. Examples include, but are not
             limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial
             infarction, uncontrolled major seizure disorder, unstable spinal cord compression,
             superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining
             informed consent

         12. Participant must not have a diagnosis of any other malignancy within 2 years prior to
             randomization, except for adequately treated basal cell or squamous cell skin cancer,
             carcinoma in situ of the breast or of the cervix, low grade prostate cancer on
             surveillance without any plans for treatment intervention, or prostate cancer that has
             been adequately treated with prostatectomy or radiotherapy and currently with no
             evidence of disease or symptoms.

         13. Participant must not have history of or known spinal cord compression, or
             carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease
             on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases
             are allowed.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Massimo Di Maio, MD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT03945084

Organization ID

Meet-URO 12


Responsible Party

Principal Investigator

Study Sponsor

University of Turin, Italy

Collaborators

 Tesaro, Inc.

Study Sponsor

Massimo Di Maio, MD, Principal Investigator, Department of Oncology, University of Turin


Verification Date

June 2021