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Metastatic Colorectal CancerPhase 2BohèmeNCT05412706

Niraparib Maintenance Treatment in mCRC With a Partial o Complete Response After Oxaliplatin-based Induction Therapy

A Phase 2 study testing Niraparib in people with Metastatic Colorectal Cancer, run by Ospedale Policlinico San Martino.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Colorectal Cancer ranks third among the most frequent malignancies representing a leading cause of cancer-related death worldwide. The constant improvement in the "continuum of care" of metastatic colorectal cancer (mCRC) patients led to a median overall survival of about 30-36 months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Niraparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
4 Sep 2023to 4 Sep 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Age ≥ 18 years at time of study entry
  • Histologically confirmed diagnosis of Stage IV colorectal adenocarcinoma
  • Disease evaluation with proven Complete Response or Partial Response according to RECIST v 1.1 after 4 months of oxaliplatin-based doublets or triplets with or without anti-VEGF or anti-EGFR agents
  • Availability of Formalin-Fixed Paraffin-Embedded tumor tissue
  • Treatment with Niraparib must be started after at least 2 weeks the end of platinum-based induction therapy up to 6 weeks
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  • Eastern Cooperative Oncology Group Performance Status < 1
  • Adequate normal organ and marrow function as follow: Haemoglobin≥9.0 g/dL; b. Absolute neutrophil count ≥1.5 × 109 /L; Platelet count ≥100 × 109/L; Serum bilirubin ≤1.5 x Upper Limit of Normal This will not apply to patients with Gilbert's syndrome; Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula; Aspartate aminotransferase /Alanine Aminotransferase ≤2.5 x Upper Limit of Normal o ≤ 5 x Upper Limit of Normal in the presence of liver metastases
  • Willing and able to comply with all of the requirements and visits in the protocol
  • Participant must agree not to donate blood during the study or for 90 days after the last dose of Niraparib
  • Fertile women must have a negative urine or serum pregnancy test within 7 days prior to taking study treatment
  • Fertile women must use highly effective contraception, starting with the screening visit through 6 months post last dose of Niraparib.
  • Male participant agrees to use an adequate method of contraception starting with the first dose of study treatment through 90 days after the last dose of study treatment.
  • Male participant must not donate sperm for 90 days after last dose of Niraparib.

Who cannot join

  • Prior adjuvant treatment for stage II/III colorectal cancer ending within 12 months before the start of induction treatment
  • Patients with Microsatellite instability high or DNA mismatch repair deficiency DSBs DNA double-strand breaks are not allowed
  • Any systemic disease that, in the opinion of the Investigator, it is not compatible with the protocol
  • Major surgery ≤ 3 weeks prior to initiating Niraparib
  • Participation in another interventional clinical trial
  • Radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy < 1 week prior to taking Niraparib
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  • Hypersensitivity to Niraparib components or excipients
  • Transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating Niraparib
  • Colony stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior Niraparib
  • Any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks
  • History of myelodysplastic syndrome, acute myeloid leukemia or Prior Reversible Encephalopathy Syndrome
  • Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection.
  • Diagnosis, detection, or treatment of another type of cancer ≤ 2 years prior to initiating Niraparib (except basal or squamous cell carcinoma of the skin and cervical cancer in situ that has been definitively treated)
  • Active infection with Human Hepatitis B Virus or Hepatitis C Virus
  • Pregnancy or breastfeeding
  • Any impairment of gastrointestinal function or disease that may significantly impair the absorption of oral drugs, malabsorption syndrome, bowel obstruction, or inability to swallow tablets).

About this study

Official title: Niraparib Maintenance Treatment in Metastatic Colorectal Cancer Patients With a Partial or Complete Response After Oxaliplatin-based Induction Therapy: Bohème Trial

Colorectal Cancer ranks third among the most frequent malignancies representing a leading cause of cancer-related death worldwide. The constant improvement in the "continuum of care" of metastatic colorectal cancer (mCRC) patients led to a median overall survival of about 30-36 months.

Due to the cumulative toxicities of first-line combinations of chemotherapy and biological agents, discontinuation or intermittent chemotherapy or maintenance strategies have been investigated in clinical trials. After a 4 to 6-month induction treatment with bevacizumab plus doublet or triplet regimens, a fluoropyrimidine plus bevacizumab is regarded as the optimal maintenance regimen. Little evidence is available on the role of maintenance with anti-EGFR agents.

Read more

A recent systematic review and network meta-analysis of 12 relevant randomized clinical trials comprising 5540 patients with mCRC showed that a maintenance strategy with a fluoropyrimidine, with or without the addition of bevacizumab, is preferred. However, given the lack of a clear overall survival benefit, shared decision-making should include observation as an acceptable alternative.

Poly(ADP)-ribose polymerase (PARP) inhibitors are now approved for breast, ovarian and pancreatic cancers. Evidence suggests that PARP inhibitors are more effective in tumors harboring homologous recombination DNA damage repair (HRR) deficiency and platinum sensitivity may be used a surrogate marker of HRD and therefore of PARP-inhibitors efficacy. An extensive Next Generation Sequencing analysis revealed that 15% of mCRC samples harbors mutations in genes involved in the HRR pathway. Several clinical trials are ongoing to test PARP inhibitors either alone or in combination in mCRC patients. The originality of this trial is to investigate PARPi in the maintenance setting.

Pre-clinical evidence showed that PARP blockade after initial oxaliplatin response delayed disease progression in mCRC carrying Kirsten Rat Sarcoma and BRAF mutations, suggesting that maintenance treatment with PARP inhibitors warrants further clinical investigation in mCRC patients who respond to oxaliplatin-containing induction treatment.

The main objective of this trial is to investigate the efficacy of anti-PARP inhibition as maintenance treatment in mCRC patients who obtained a complete or partial response after 4-month induction treatment with oxaliplatin-based double or triplet plus biologic agents.

Read the detailed description

Multicenter phase II no profit study investigating the disease-free survival efficacy of niraparib as maintenance treatment in 46 patients with metastatic colorectal cancer with partial or complete response after oxaliplatin-based induction therapy.

The study also includes translational research objectives.

Being tested
Niraparib
Keywords
Niraparib metastatic colorectal cancer PARP1 PARP2 inhibitor
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NiraparibDrug

    Also called Zejula

    Patients will receive Niraparib 200-300 mg orally as an individualized weight and platelet-based, flat-fixed, continuous daily dose.

    Niraparib will be administered orally once daily in 28-day cycles.

Study groups in NCT05412706
Study groupRoleWhat they receive
Treatment ArmExperimentalTreatment with Niraparib must be started after at least 2 weeks and no later than 6 weeks after the end of platinum-based induction therapy.
Receives: Drug: Niraparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival 1

    Progression-Free Survival 1 is defined as the time from the patient registration to the date of first radiographic progression by RECIST guidelines (version 1.1), or death from any cause in the absence of progression, whichever occurs first.

    Measured: 36 months

Secondary outcomes (4)

  1. Progression-Free Survival (2) after re-introduction of first-line treatment combination

    Progression-Free Survival (2) is defined as the patient registration to progression or death from any cause in the absence of progression, whichever comes first on anticancer treatment following maintenance therapy.

    Measured: 36 months

  2. Overall Survival

    Overall Survival is defined as time from patient registration until death from any cause. If no event (death) has been observed, the patient is censored at the date of last follow up

    Measured: 36 months

  3. Objective Response Rate

    Objective Response Rate is defined as the percentage of patients with Complete Response or Partial Response, as assessed by Response Evaluation Criteria in Solid Tumors v.1.1 criteria using an independent review.

    Measured: 36 months

  4. Incidence of Treatment-Emergent Adverse Events

    Toxicity / adverse events classified according to NCI-Common Terminology Criteria for Adverse Events version 5.0.

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2022
  2. Study start4 Sep 2023
  3. Primary completion4 Sep 2023
  4. Study completion4 Sep 2023

Why it stopped: The Principal Investigator has retired and has not been replaced has retired and a new one has not been identified Principal Investigator

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05412706
Sponsor's protocol ID
Bohème
Acronym
Bohème
Status last verified
Sep 2023
First submitted
25 May 2022
Last updated
8 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Niraparib in people with Metastatic Colorectal Cancer, run by Ospedale Policlinico San Martino.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival 1 (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05412706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.

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Bohème Clinical Trial NCT05412706 | AzTrials