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Niraparib for Pancreatic Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sarah Cannon Reasearch Institute at HealthONE, Denver, COPancreatic Adenocarcinoma+17 MoreNiraparib - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new cancer drug, PEN-866, on patients with advanced solid tumors who have already tried other treatments that haven't worked.

Eligible Conditions
  • Anal Squamous Cell Carcinoma
  • Pancreatic Adenocarcinoma
  • Stomach Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Small Cell Lung Cancer
  • Solid Tumors
  • Advanced Cancer
  • Endometrial Adenocarcinoma
  • Squamous Cell Carcinoma
  • Solid Cancer
  • Cervical Squamous Cell Carcinoma
  • Pancreatic Cancer
  • Cancer
  • Squamous Cell Carcinoma of the Vulva
  • Tumors
  • Penile Squamous Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

7 Primary · 11 Secondary · Reporting Duration: Baseline and every 6 weeks until date of first documented progression or death (estimated 6 months)

Month 18
Area under the curve (AUC) of PEN-866 and its components (HSP90 ligand and SN-38)
Half-life (t1/2) of PEN-866 and its components (HSP90 ligand and SN-38)
Maximum concentration (Cmax) of PEN-866 and its components (HSP90 ligand and SN-38)
14 days
Phase 1b: Characterize the plasma pharmacokinetics (PK) of the combination therapies and their components
Month 6
Phase 1a: Tumor response using RECIST 1.1 criteria
Month 18
Phase 1b: Disease Control Rate
Adenocarcinoma
Month 18
Phase 2a: Evaluate the best overall response rate in patients with pancreatic adenocarcinoma
Month 18
Phase 1b and 2a: Duration of Response
Phase 2a: Overall survival
Month 18
Phase 2a: Radiographic progression free survival
Day 28
All Phases: Incidence of treatment related adverse events (Safety and tolerability)
Month 18
Phase 2a: Efficacy of PEN-866 in patients with SCLC using best overall response rate
Phase 2a: Efficacy of PEN-866 in patients with endometrial adenocarcinoma using best overall response rate
Phase 2a: Efficacy of PEN-866 in patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma using best overall response rate
Phase 2a: Efficacy of PEN-866 in patients with pancreatic adenocarcinoma using Disease Control Rate (DCR)
Phase 2a: Efficacy of PEN-866 in patients with squamous cell carcinoma of the genitalia (anus, cervix, vulva, or penis) using best overall response rate
Day 28
Phase 1a and 1b : Incidence of Dose-Limiting Toxicities (DLTs)

Trial Safety

Safety Progress

1 of 3

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1
Niraparib
1
JSI-1187
2
Niraparib

Side Effects for

Stage 1 (Cohort 2): Niraparib + Pembrolizumab
57%Nausea
52%Decreased appetite
48%Constipation
48%Anaemia
43%Fatigue
38%Dyspnoea
24%Platelet count decreased
24%Vomiting
24%Oedema peripheral
24%Stomatitis
19%Blood alkaline phosphatase increased
19%Insomnia
19%Arthralgia
19%Pruritus
14%Chills
14%Diarrhoea
14%Weight decreased
14%Dysgeusia
14%Cough
14%Pneumonia
14%Pain
14%Upper respiratory tract infection
14%Neutrophil count decreased
14%Back pain
14%Muscular weakness
10%Non-cardiac chest pain
10%Chest pain
10%Productive cough
10%Urinary tract infection
10%Gait disturbance
10%Wheezing
10%Haemorrhoids
10%Alanine aminotransferase increased
10%Proctalgia
10%Pleural effusion
10%Atrial fibrillation
10%Haemorrhoidal haemorrhage
10%Oropharyngeal pain
10%Dehydration
10%Hypokalaemia
10%Hypophosphataemia
10%Aspartate aminotransferase increased
10%Blood creatinine increased
10%Lymphocyte count decreased
10%Neuropathy peripheral
10%Anxiety
10%Depression
10%Rash maculo-papular
10%Erythema
10%Pain of skin
10%Overdose
10%Hypothyroidism
10%Vision blurred
5%Diverticulitis
5%Neuroendocrine carcinoma of the skin
5%Dizziness
5%Fall
5%Contusion
5%Angina pectoris
5%Haematochezia
5%Tachycardia
5%Cancer pain
5%Hyponatraemia
5%Candida infection
5%Dysphonia
5%Toxicity to various agents
5%Gastrooesophageal reflux disease
5%Peripheral sensory neuropathy
5%Pulmonary embolism
5%Sepsis
5%Hepatic enzyme increased
5%Lipase increased
5%Pneumonitis
5%Respiratory failure
5%Cardiac arrest
5%Pericardial effusion
5%Intestinal obstruction
5%Lactic acidosis
5%Abdominal pain
5%Nasal congestion
5%Pyrexia
5%Asthenia
5%Malaise
5%Hypomagnesaemia
5%Amylase increased
5%Headache
5%Lethargy
5%Pain in extremity
5%Hyperhidrosis
5%Sinus tachycardia
5%Hypotension
5%Syncope
5%Hyperglycaemia
This histogram enumerates side effects from a completed 2021 Phase 2 trial (NCT03308942) in the Stage 1 (Cohort 2): Niraparib + Pembrolizumab ARM group. Side effects include: Nausea with 57%, Decreased appetite with 52%, Constipation with 48%, Anaemia with 48%, Fatigue with 43%.

Trial Design

4 Treatment Groups

Phase 1b PEN-866 Sodium + Flurouracil + Folinic Acid
1 of 4
Phase 2a PEN-866 Sodium (Single Agent)
1 of 4
Phase 1a PEN-866 Sodium (Single Agent)
1 of 4
Phase 1b PEN-866 Sodium + Niraparib
1 of 4

Experimental Treatment

340 Total Participants · 4 Treatment Groups

Primary Treatment: Niraparib · No Placebo Group · Phase 1 & 2

Phase 1b PEN-866 Sodium + Flurouracil + Folinic AcidExperimental Group · 3 Interventions: PEN-866 Sodium, Folinic acid, fluorouracil · Intervention Types: Drug, Drug, Drug
Phase 2a PEN-866 Sodium (Single Agent)
Drug
Experimental Group · 1 Intervention: PEN-866 Sodium · Intervention Types: Drug
Phase 1a PEN-866 Sodium (Single Agent)
Drug
Experimental Group · 1 Intervention: PEN-866 Sodium · Intervention Types: Drug
Phase 1b PEN-866 Sodium + NiraparibExperimental Group · 2 Interventions: PEN-866 Sodium, Niraparib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
FDA approved
Fluorouracil
FDA approved
Niraparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and every 6 weeks until date of first documented progression or death (estimated 6 months)

Who is running the clinical trial?

Tarveda TherapeuticsLead Sponsor
1 Previous Clinical Trials
89 Total Patients Enrolled
Anish Thomas, MDStudy ChairNational Cancer Institute (NCI)

Eligibility Criteria

Age 18+ · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to be using effective birth control during the study.
For Phase 2a, you must have a history of specific types of cancer listed below and have received chemotherapy treatment in the past, but your cancer has continued to grow or spread: - Small Cell Lung Cancer (SCLC) - Gastric or gastroesophageal (GEJ) adenocarcinoma - Squamous cell carcinoma (SCC) of the genitalia (anus, cervix, vulva, or penis) - Pancreatic adenocarcinoma (PDAC) - Endometrial adenocarcinoma (EC)
References

Frequently Asked Questions

To date, how many people have opted in for this experiment?

"In order to move forward, this study requires 340 participants that fit the pre-determined inclusion criteria. Patients can enroll at different locations such as Florida Cancer Specialists - North in Saint Petersburg, Florida and National Institutes of Health / National Cancer Institute in Bethesda, Maryland." - Anonymous Online Contributor

Unverified Answer

Are there still opportunities for people to enroll in this research project?

"This study is currently looking for candidates, as reported on clinicaltrials.gov. The trial was originally posted on 8/29/2017 and was most recently updated on 2/16/2022." - Anonymous Online Contributor

Unverified Answer

Can you explain what the common applications are for Niraparib?

"Niraparib is a popular choice for patients with primary peritoneal cancer. It has also been used to help those suffering from advanced esophageal cancers, folate, and advanced gastric cancer." - Anonymous Online Contributor

Unverified Answer

Is this clinical trial widely available in Canada?

"The trial is currently underway at 16 sites, which include Florida Cancer Specialists - North in Saint Petersburg, National Institutes of Health / National Cancer Institute in Bethesda, Sarah Cannon Reasearch Institute at HealthONE in Denver, and others." - Anonymous Online Contributor

Unverified Answer

Is there precedent for the use of Niraparib in patients?

"Currently, there are 501 clinical trials in progress that are investigating Niraparib. 145 of those active trials are in Phase 3. While the many studies for Niraparib are based in Woolloongabba, Queensland, there are a total of 25222 locations running trials for this treatment around the world." - Anonymous Online Contributor

Unverified Answer

What are the researchers hoping to find at the end of this clinical trial?

"According to the sponsor of this clinical trial, Tarveda Therapeutics, the primary outcome of this study will be Phase 2a: Efficacy of PEN-866 in patients with endometrial adenocarcinoma using best overall response rate. This efficacy will be measured over an 18 month period from the date of first treatment. Additionally, this study will also evaluate secondary outcomes including Phase 2a: Disease Control Rate in patients with SCLC, gastric or gastroesophageal junction adenocarcinoma, endometrial adenocarcinoma, and squamous cell carcinoma of" - Anonymous Online Contributor

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

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