CLINICAL TRIAL

Niraparib for HRD

Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · Indianapolis, IN

This study is evaluating whether a new treatment for cholangiocarcinoma is effective.

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About the trial for HRD

Eligible Conditions
HRD · Cholangiocarcinoma · Metastatic Cancers

Treatment Groups

This trial involves 2 different treatments. Niraparib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Niraparib
DRUG
Dostarlimab
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Niraparib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
You are not able to perform any of the following activities: walk, stand, or sit. show original
The cancer must be either primary or metastatic to the biliary tract. show original
Measurable disease according to RECIST 1.1 within 28 days prior to registration.
Must have a defined HRD signature (BRCA1, BRCA2, PALB2, MRE, CHEK1, CHEK2, PTEN, ATM, ATR, BER, RPA1, RAD51, BARD1, BRIP1, FAAP20, FANCM, FAN1, NBN, EMSY, MRE11, ARID1A, BAP-1.) NOTE: Clinical Laboratory Improvement Act (CLIA)-certified assays including commercial tests (Foundation Medicine, Caris, Tempus, Guardant 360 or other platforms of next generation sequencing) will be allowed.
Patients must have achieved complete response (CR), partial response (PR) or stable disease (SD) after 4 to 6 months of any platinum-based therapy.
Prior treatment with immune therapy is allowed. Exception: prior treatment with PARP inhibitors is not allowed.
Prior cancer treatment must be completed at least 21 days prior to registration. Toxicities attributed to prior therapy/procedure must have resolved to Grade ≤ 1. Exceptions include alopecia and oxaliplatin induced neurotoxicity ≤ Grade 2. C1D1 treatment will start no more than 28 days after completion of prior cancer treatment. Patients that are > 28 days from completion of prior treatment will need to be discussed with the sponsor-investigator.
Life expectancy of ≥ 16 weeks per estimation of site investigator.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 5years
Screening: ~3 weeks
Treatment: Varies
Reporting: 5years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 5years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Niraparib will improve 1 primary outcome and 5 secondary outcomes in patients with HRD. Measurement will happen over the course of 4-6 months.

Progression Free Survival (PFS)
4-6 MONTHS
Evaluate PFS of patients who achieved a complete response (CR), partial response (PR) or stable disease (SD). PFS is defined as the date of treatment initiation (C1D1) until the criteria for disease progression is met as defined by RECIST 1.1 or death occurs
4-6 MONTHS
Disease Control Rate (DCR)
5 YEARS
Disease control rate (DCR) is the percentage of subjects with SD, PR, or CR according to RECIST 1.1.
5 YEARS
Frequency and Severity of Adverse Events
5 YEARS
Adverse events will be assessed using the National Cancer Institution Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5
5 YEARS
Objective Response Rate (ORR)
5 YEARS
ORR is the proportion of all subjects with confirmed PR or CR as the Best Overall Response according to RECIST 1.1, from treatment initiation (C1D1) until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment).
5 YEARS
Duration of Response (DOR)
5 YEARS
DoR is defined as the period measured from the time that RECIST 1.1 criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started).
5 YEARS
Overall Survival (OS)
5YEARS
OS is defined as the period measured from the date of treatment initiation (C1D1) to the date of death from any cause.
5YEARS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes cholangiocarcinoma?

In addition to hepatogenic bile duct carcinoma, cholangiocarcinoma may also be a result of chronic inflammation caused by infection or chronic liver disease, especially with the association of gallbladder cancer.

Anonymous Patient Answer

How many people get cholangiocarcinoma a year in the United States?

The number of new annual CCA cases is estimated to be around 8,000 per year in the United States. In terms of proportion, the National Institutes of Health (NIH) estimates that around 6.6% of all people with non-kaposi's sialadenitis will develop a CCA.

Anonymous Patient Answer

What are the signs of cholangiocarcinoma?

Cholangiocarcinoma presents early and can be easily diagnosed. It is advisable to diagnose cholangiocarcinoma as early as possible, and treatment should be started at a reasonable time so that the cancer can be cured completely. Moreover, it is important to monitor patients for signs of recurrence after removing the cancer completely.

Anonymous Patient Answer

Can cholangiocarcinoma be cured?

Even if radical surgical resection is considered as cure, recurrences have been reported in some cases following curative surgery. These have also been reported as failures in others. Even if radical surgery can eradicate cholangiocarcinoma, it appears that the disease may re-emerge in the remnant liver following post-surgical remission. New therapies and strategies to control the tumor in the remnant liver are necessary.

Anonymous Patient Answer

What is cholangiocarcinoma?

Cholangiocarcinoma is the sixth most common cancer of the bile duct and accounts for 15% of the malignant intrahepatic bile duct neoplasms. It is a neoplasm that forms when bile duct epithelial cells become malignant. cholangiocarcinoma most commonly occurs at 35 to 65 years of age and is more common in men than in women. The median survival postdiagnosis is less than 2 years. It has a poor prognosis after curative surgery and patients will need to be monitored after surgery for recurrence.

Anonymous Patient Answer

What are common treatments for cholangiocarcinoma?

Treatment for cholangiocarcinoma should be tailored to the individual patient. The first potential treatment for cholangiocarcinoma (BCLC stage B) is biliary drainage, i.e., biliary tract obstruction. Surgical resection is recommended when the tumor is resectable (BCLC stage A and T3). Liver transplantation should also be considered for advanced cases. Postoperative adjuvant chemotherapy may improve local and regional control for recurrence in T3 stages T1 and T2 cancers. For BLCC stage C, radiotherapy is a key treatment modality. For all stages, systemic treatment of CCA with chemotherapy and cytotoxic agents is also encouraged.

Anonymous Patient Answer

How quickly does cholangiocarcinoma spread?

Recent findings suggest that, even if complete surgical resection is achieved for patients with CCA, a local recurrence or distant metastasis of CCA will always occur. Hence, the ultimate outcome of this rare malignancy has not improved appreciably even with modern surgical techniques and postoperative adjuvant therapy.

Anonymous Patient Answer

Does niraparib improve quality of life for those with cholangiocarcinoma?

Niraparib did not significantly improve global QoL or bothersome symptoms in patients with cholangiocarcinoma. However, an analysis on the specific domains suggested that specific symptoms such as fatigue and nausea were improved. Data from a recent study support the use of niraparib for the treatment of refractory cholangiocarcinoma.

Anonymous Patient Answer

What is the average age someone gets cholangiocarcinoma?

The prevalence of cholangiocarcinoma among males is more than six times of that among females in Taiwan. The peak age of cholangiocarcinomas is over 65 years of age, but still far lower than that found in Western populations.

Anonymous Patient Answer

What is the survival rate for cholangiocarcinoma?

There is an improvement in survival over the last 10 years. Patients who do not have distant metastasis have a greater chance of survival than those with distant metastases. Patients who have resection or lymph node irradiation have a significantly longer survival. Therefore, there is an ongoing battle between the extent of surgery, the amount of chemotherapy and the amount of radiation that the patient receives. Nevertheless, a long-term survival can be achieved.

Anonymous Patient Answer

Is niraparib safe for people?

Niraparib is an option for first-line treatment of patients with metastatic or adjuvant ovarian cancer and may benefit patients with gastrointestinal stromal tumours due to its ability to target both Hsp-90 and IGF-1Rs. These preliminary data suggest that there is an acceptable safety profile for niraparib in patients with gastrointestinal stromal tumours although these studies represent preliminary data.

Anonymous Patient Answer

What are the latest developments in niraparib for therapeutic use?

Niraparib has completed a pivotal clinical trial in advanced [metastatic breast cancer](https://www.withpower.com/clinical-trials/metastatic-breast-cancer) and is one of the most effective chemotherapeutic drugs currently available to patients with metastatic breast cancer. The use of niraparib combined with the anticancer agent trastuzumab, a molecule that targets and inhibits HER2 receptors, has shown significant antitumor effects in patients with untreated metastatic breast carcinoma. However, due to the occurrence of serious adverse effects during the treatment of a subset of patients, niraparib is not an approved drug in many countries, including the United States.

Anonymous Patient Answer
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