What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine and its combinations, are associated with several side effects. Gemcitabine alone can cause fatigue, nausea, vomiting, low blood counts, and liver enzyme abnormalities. When combined with nab-paclitaxel, additional side effects include neuropathy, diarrhea, and neutropenia. FOLFIRINOX, another common regimen, often results in more severe side effects like neutropenia, fatigue, diarrhea, and peripheral neuropathy. These treatments aim to manage the disease but come with a significant burden of adverse effects that need to be managed carefully.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer that involve gemcitabine. Notably, gemcitabine alone has been a standard treatment for advanced pancreatic cancer. Additionally, the combination of gemcitabine with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) has shown improved outcomes in terms of response rate and overall survival compared to gemcitabine alone. This combination was approved based on the results of the MPACT trial. Another combination, FOLFIRINOX (which includes fluorouracil, leucovorin, irinotecan, and oxaliplatin), has also been used for treating pancreatic cancer, although it does not include gemcitabine. These treatments highlight the ongoing efforts to improve therapeutic outcomes for pancreatic cancer patients.

What other types of research exist?

Promising novel alternatives to GP-2250 for pancreatic cancer treatment include: 1) RC-3095, a bombesin/GRP receptor antagonist, which may inhibit pancreatic cancer by interfering with EGF-receptor mechanisms. 2) The inverso isomer of CendR peptide (<subD</sub(RGERPPR)), which has shown significant tumor suppression when co-administered with gemcitabine. 3) Troglitazone, which exhibits cytotoxic effects via the JNK pathway. 4) Substance 2250, an innovative structural analogue of Taurultam, demonstrating anti-neoplastic effects. 5) Recombinant Thrombomodulin (rTM), which enhances the effects of gemcitabine through GPR15-dependent mechanisms. 6) NVP-BEZ235, a dual PI3K/mTOR inhibitor, which has shown additive effects on proliferation inhibition when combined with gemcitabine.

← Back to Search

Other

GP-2250 + Gemcitabine for Pancreatic Cancer

Phase 1

Recruiting

Research Sponsored by Geistlich Pharma AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female subjects age > 18 years at the time of trial entry.

Subjects must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.

Must not have

Subject has undergone major surgery, other than diagnostic surgery (ie, surgery done to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior to Day 1 of treatment in this study.

Subjects has a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonia or multiple allergies, clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome with <=6 months prior to the start of study treatment, symptomatic or uncontrolled arrhythmia, congestive heart failure, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or ascites requiring paracentesis in the 4 weeks prior to Screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, GP-2250, combined with gemcitabine for patients with advanced pancreatic cancer who haven't responded to other treatments. The goal is to see if this combination works better than existing options. Gemcitabine has been widely used in the treatment of advanced pancreatic cancer, often in combination with other drugs to improve results.

Who is the study for?

Adults over 18 with advanced pancreatic cancer that's unremovable or has spread, and who've had certain previous chemotherapies can join. They need a measurable tumor, good blood counts, organ function, and must use effective birth control. Exclusions include recent other cancers (except some skin/breast/cervical), heart disease, lung conditions, major surgery within the last month, or COVID-19 recently.

What is being tested?

The trial is testing GP-2250 combined with gemcitabine in patients who have previously been treated with fluorouracil-based chemotherapy for their pancreatic cancer. It's a phase 1 trial to see what doses are safe and how well patients tolerate this combination treatment.

What are the potential side effects?

Since it's an early-phase trial for GP-2250 plus gemcitabine after specific prior treatments, detailed side effects aren't listed but may include typical chemotherapy-related issues like nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

Select...

I am fully active or can carry out light work.

Select...

My pancreatic cancer cannot be removed by surgery and has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not had major surgery, except for a biopsy, in the last 4 weeks.

Select...

I have lung issues, heart disease, or severe allergies.

Select...

I have a history or current signs of bleeding in the eye or glaucoma.

Select...

I haven't had cancer treatment or surgery within the last 3 to 6 weeks.

Select...

I have a history of sickle cell disease or a similar inherited anemia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Toxicity (DLT)

Secondary study objectives

Carbohydrate Antigen 19-9 (CA-19-9)

Effect on disease

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: GP-2250 MonotherapyExperimental Treatment1 Intervention

GP-2250 in doses of 250 mg up to 30 grams intravenously on Days -7, 1, 8, 15 (Cycle 1) and Cycle 2 and all subsequent cycles on Days 7, 8, 15 of a 28-day cycle with gemcitabine 1000 mg/m2 on Days 1, 8, 15 days of the cycle.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pancreatic cancer, such as gemcitabine, work by inhibiting DNA synthesis, leading to cancer cell death. Gemcitabine is often combined with other agents like nab-paclitaxel, which disrupts microtubule function, or FOLFIRINOX, a multi-drug regimen targeting DNA replication and repair. These mechanisms are vital for patients to understand as they illustrate how these treatments aim to stop cancer progression and improve survival outcomes.

GPRC5A is a potential oncogene in pancreatic ductal adenocarcinoma cells that is upregulated by gemcitabine with help from HuR.Phase III trial of radiosensitizer PR-350 combined with intraoperative radiotherapy for the treatment of locally advanced pancreatic cancer.