NCT01182246

Safety, Pharmacokinetics and Efficacy of AXP107-11 in Combination With Standard Gemcitabine (Gemzar®) Treatment in Patients With Locally Advanced or Metastatic, Unresectable, Adenocarcinoma of the Pancreas, Stage III-IV: A Prospective, Open Label, Multi-centre, Sequential Phase Ib/IIa Study

Status unknown Phase 1/Phase 2 Last updated 22 April 2014

What this trial tests

Phase 1/Phase 2 trial testing AXP107-11 in Adenocarcinoma in 44 participants. Status unknown.

Timeline

1 November 2010

Primary endpoint
1 March 2016

1 March 2016

Quick facts

Lead sponsor	Axcentua Pharmaceuticals AB
Phase	Phase 1/Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	1 November 2010
Primary completion	1 March 2016
Estimated completion	1 March 2016
Sites	2 locations across Sweden

Drugs / interventions tested

• AXP107-11 — full drug profile →

Conditions studied

• Adenocarcinoma — all drugs for Adenocarcinoma →

Sponsor

Axcentua Pharmaceuticals AB — full company profile →

Who can join

18 and older, any sex, with Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Determine the safety profile and the maximum tolerated dose (MTD) of AXP107-11 alone and when given in combination with gemcitabine standard therapy.
  Time frame: up to 6 months
  Safety (AEs, dose limiting toxicity, laboratory tests, vital signs, weight and ECG). MTD is defined at day 8.
• To assess the effect of a combination therapy of AXP107-11 and gemcitabine on objective response rate defined as the percentage of patients who showed complete response (CR) or partial response (PR).
  Time frame: up to 6 months
  The tumour response evaluation will be performed according to RECIST (www.recist.org)

Sponsor's own description

The purpose of this study is to assess the effect and safety of AXP107-11 alone, and in combination with gemcitabine standard therapy, in patients with advanced or metastatic cancer of the pancreas. The safety, pharmacokinetics and efficacy of AXP107-11 in these patients will also be studied.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Hallmarks of Flavonoids in Cancer.
   Ponte LGS, Pavan ICB, Mancini MCS, da Silva LGS, et al · · 2021 · cited 94× · PMID 33918290 · DOI 10.3390/molecules26072029
2. Regulation of microRNAs by natural agents: new strategies in cancer therapies.
   Phuah NH, Nagoor NH. · · 2014 · cited 90× · PMID 25254214 · DOI 10.1155/2014/804510
3. Targeting tumor ubiquitin-proteasome pathway with polyphenols for chemosensitization.
   Shen M, Chan TH, Dou QP. · · 2012 · cited 41× · PMID 22292765 · DOI 10.2174/187152012802649978
4. Novel approaches in the management of pancreatic ductal adenocarcinoma: potential promises for the future.
   Goel G, Sun W. · · 2015 · cited 31× · PMID 25935754 · DOI 10.1186/s13045-015-0141-5
5. The Role of Nutraceuticals in Pancreatic Cancer Prevention and Therapy: Targeting Cellular Signaling, MicroRNAs, and Epigenome.
   Li Y, Go VL, Sarkar FH. · · 2015 · cited 30× · PMID 25493373 · DOI 10.1097/mpa.0000000000000257
6. The Glycolytic Pathway as a Target for Novel Onco-Immunology Therapies in Pancreatic Cancer.
   Curcio C, Brugiapaglia S, Bulfamante S, Follia L, et al · · 2021 · cited 23× · PMID 33804240 · DOI 10.3390/molecules26061642
7. Exploring the pharmacokinetics, drug-likeness, and toxicological features of anticancer flavonoids: a Boulevard to explore their clinical translational potential.
   Dubey AK, Chandragiri SS, Geevarghese AV, Kapoor B, et al · · 2025 · cited 2× · PMID 41111522 · DOI 10.3389/fphar.2025.1648395
8. Targeting Cancer Stem Cells with Phytochemicals: Molecular Mechanisms and Therapeutic Potential.
   Sah AK, Das J, Umarovich AI, Agarwal S, et al · · 2026 · cited 1× · PMID 41595749 · DOI 10.3390/biomedicines14010215