NCT02227940

Ceritinib and Combination Chemotherapy in Treating Patients With Advanced Solid Tumors or Locally Advanced or Metastatic Pancreatic Cancer

Completed Phase 1 Last updated 25 July 2022

What this trial tests

Phase 1 trial testing Ceritinib in Advanced Malignant Solid Neoplasm in 38 participants. Completed in 12 February 2019.

Timeline

8 January 2015

Primary endpoint
27 December 2018

12 February 2019

Quick facts

Lead sponsor	Roswell Park Cancer Institute
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	8 January 2015
Primary completion	27 December 2018
Estimated completion	12 February 2019
Sites	1 location across United States

Drugs / interventions tested

• Ceritinib (ceritinib) — full drug profile →
• Cisplatin (cisplatin) — full drug profile →
• Gemcitabine Hydrochloride — full drug profile →
• Laboratory Biomarker Analysis
• Paclitaxel Albumin-Stabilized Nanoparticle Formulation
• Pharmacological Study

Conditions studied

• Advanced Malignant Solid Neoplasm — all drugs for Advanced Malignant Solid Neoplasm →
• ALK Positive — all drugs for ALK Positive →
• Metastatic Pancreatic Adenocarcinoma — all drugs for Metastatic Pancreatic Adenocarcinoma →
• Stage III Pancreatic Cancer — all drugs for Stage III Pancreatic Cancer →

Sponsor

Roswell Park Cancer Institute

Who can join

18 and older, any sex, with Advanced Malignant Solid Neoplasm or ALK Positive. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of ceritinib and combination chemotherapy in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Ceritinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, paclitaxel albumin-stabilized nanoparticle formulation, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ceritinib and more than one drug (combination chemotherapy) may be a better treatment for solid tumors or pancreatic cancer.

Publications & conference data

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

1. The molecular biology of pancreatic adenocarcinoma: translational challenges and clinical perspectives.
   Wang S, Zheng Y, Yang F, Zhu L, et al · · 2021 · cited 252× · PMID 34219130 · DOI 10.1038/s41392-021-00659-4
2. Nanoparticles in Clinical Translation for Cancer Therapy.
   Mundekkad D, Cho WC. · · 2022 · cited 146× · PMID 35163607 · DOI 10.3390/ijms23031685
3. KRAS wild-type pancreatic ductal adenocarcinoma: molecular pathology and therapeutic opportunities.
   Luchini C, Paolino G, Mattiolo P, Piredda ML, et al · · 2020 · cited 75× · PMID 33115526 · DOI 10.1186/s13046-020-01732-6
4. Nano albumin bound-paclitaxel in pancreatic cancer: Current evidences and future directions.
   Giordano G, Pancione M, Olivieri N, Parcesepe P, et al · · 2017 · cited 67× · PMID 28932079 · DOI 10.3748/wjg.v23.i32.5875
5. Metastatic pancreatic cancer: Is there a light at the end of the tunnel?
   Vaccaro V, Sperduti I, Vari S, Bria E, et al · · 2015 · cited 49× · PMID 25944992 · DOI 10.3748/wjg.v21.i16.4788
6. Combination Therapies and Drug Delivery Platforms in Combating Pancreatic Cancer.
   Lei F, Xi X, Batra SK, Bronich TK. · · 2019 · cited 33× · PMID 30796131 · DOI 10.1124/jpet.118.255786
7. Novel agents for pancreatic ductal adenocarcinoma: emerging therapeutics and future directions.
   Zhang Y, Yang C, Cheng H, Fan Z, et al · · 2018 · cited 25× · PMID 29386069 · DOI 10.1186/s13045-017-0551-7
8. Targeted Nanoparticle-Based Diagnostic and Treatment Options for Pancreatic Cancer.
   Gu X, Minko T. · · 2024 · cited 24× · PMID 38672671 · DOI 10.3390/cancers16081589