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.
- 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
- Squamous Cell Carcinoma of the Vulva
- Penile Squamous Cell Carcinoma
7 Primary · 11 Secondary · Reporting Duration: Baseline and every 6 weeks until date of first documented progression or death (estimated 6 months)
Side Effects for
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
340 Total Participants · 4 Treatment Groups
Primary Treatment: Niraparib · No Placebo Group · Phase 1 & 2
Who is running the clinical trial?
Age 18+ · All Participants · 11 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
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
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
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
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
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
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