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Alkylating agents

Niraparib for Stomach Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Tarveda Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and every 6 weeks until date of first documented progression or death (estimated 6 months)
Awards & highlights

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
  • Stomach Cancer
  • Pancreatic Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Endometrial Adenocarcinoma
  • Tumors
  • Anal Squamous Cell Carcinoma
  • Small Cell Lung Cancer
  • Cancer
  • Solid Tumors
  • Cervical Carcinoma
  • Squamous Cell Carcinoma
  • Penile Squamous Cell Carcinoma
  • Pancreatic Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and every 6 weeks until date of first documented progression or death (estimated 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 6 weeks until date of first documented progression or death (estimated 6 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All Phases: Incidence of treatment related adverse events (Safety and tolerability)
Phase 1a and 1b : Incidence of Dose-Limiting Toxicities (DLTs)
Phase 2a: Efficacy of PEN-866 in patients with SCLC using best overall response rate
+4 more
Secondary outcome measures
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)
+8 more

Side effects data

From 2022 Phase 2 trial • 37 Patients • NCT03207347
74%
Fatigue
52%
Nausea
39%
Constipation
39%
Anorexia
30%
Anemia
30%
Alkaline phosphatase increased
26%
Weight loss
22%
Dyspnea
22%
Abdominal pain
22%
Dizziness
22%
Insomnia
17%
Headache
17%
Platelet count decreased
17%
Mucositis oral
17%
Creatinine increased
13%
Sinus tachycardia
13%
Vomiting
13%
Rash maculo-papular
13%
Aspartate aminotransferase increased
9%
Anxiety
9%
Alanine aminotransferase increased
9%
Urinary tract infection
9%
Dehydration
9%
Back pain
9%
Blood bilirubin increased
9%
Dry mouth
9%
Cough
9%
Hypertension
9%
Non-cardiac chest pain
4%
Esophageal ulcer
4%
Skin tear
4%
Diarrhea
4%
Edema limbs
4%
Leukocytosis
4%
Syncope
4%
Hypotension
4%
Head injury
4%
Oral petechia
4%
Sinus pain
4%
Unknown infection
4%
Ascites
4%
Bruising
4%
Itchy eyes
4%
Flu like symptoms
4%
Hoarseness
4%
Peripheral sensory neuropathy
4%
Sore throat
4%
Upper respiratory infection
4%
Neutrophil count decreased
4%
Lung infection
4%
White blood cell decreased
4%
Depression
4%
Hyponatremia
4%
Hypokalemia
4%
Postnasal drip
4%
Hyperkalemia
4%
Bloating
4%
Hot flashes
4%
Hyperglycemia
4%
Hematuria
4%
Tremor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A
Cohort B

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2a PEN-866 Sodium (Single Agent)Experimental Treatment1 Intervention
Intravenously administered PEN-866 Sodium at the Recommended Phase 2 Dose
Group II: Phase 1b PEN-866 Sodium + NiraparibExperimental Treatment2 Interventions
Dose escalation of intravenous administration of PEN-866 Sodium in combination with niraparib
Group III: Phase 1b PEN-866 Sodium + Flurouracil + Folinic AcidExperimental Treatment3 Interventions
Dose escalation of intravenous administration of PEN-866 Sodium in combination with fluorouracil and folinic acid
Group IV: Phase 1a PEN-866 Sodium (Single Agent)Experimental Treatment1 Intervention
Dose escalation of PEN-866 Sodium administered intravenously
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fluorouracil
1994
Completed Phase 3
~8440
Folinic acid
2012
Completed Phase 3
~1290
Niraparib
2018
Completed Phase 4
~1540

Find a Location

Who is running the clinical trial?

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

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PEN-866 in Patients With Advanced Solid Malignancies
2017. "PEN-866 in Patients With Advanced Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03221400.
~45 spots leftby Apr 2025
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