NCT01240642

A Multi-center, Open-label, Dose-escalation Study in Patients With Advanced Cacner to Determine the Effect of the ASA404 Infusion Rate and Co-administration With the Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokinetics of Free and Total ASA404

Terminated Phase 1 Last updated 6 December 2020

What this trial tests

Phase 1 trial testing ASA404 in Metastatic Cancer With Impaired Renal Function in 27 participants. Terminated before completion.

Timeline

1 January 2010

Primary endpoint
1 December 2010

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	1 January 2010
Primary completion	1 December 2010
Sites	4 locations across Belgium

Drugs / interventions tested

• ASA404 — full drug profile →

Conditions studied

• Metastatic Cancer With Impaired Renal Function — all drugs for Metastatic Cancer With Impaired Renal Function →
• Metastatic Cancer With Normal Renal Function — all drugs for Metastatic Cancer With Normal Renal Function →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Metastatic Cancer With Impaired Renal Function or Metastatic Cancer With Normal Renal Function. 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.

• To evaluate the pK of a single intravenous dose of ASA404 1200 and 1800 mg/m2 monotherapy in adult cancer patients with impaired renal function compared to matching patients with normal renal function
  Time frame: 12 monnths

Sponsor's own description

The purpose of this study is to determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404.

Publications & conference data

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

1. STING: a master regulator in the cancer-immunity cycle.
   Zhu Y, An X, Zhang X, Qiao Y, et al · · 2019 · cited 309× · PMID 31679519 · DOI 10.1186/s12943-019-1087-y
2. Trial watch: STING agonists in cancer therapy.
   Le Naour J, Zitvogel L, Galluzzi L, Vacchelli E, et al · · 2020 · cited 201× · PMID 32934881 · DOI 10.1080/2162402x.2020.1777624
3. Multifaceted functions of STING in human health and disease: from molecular mechanism to targeted strategy.
   Zhang Z, Zhou H, Ouyang X, Dong Y, et al · · 2022 · cited 127× · PMID 36550103 · DOI 10.1038/s41392-022-01252-z
4. The Development of STING Agonists and Emerging Results as a Cancer Immunotherapy.
   Hines JB, Kacew AJ, Sweis RF. · · 2023 · cited 92× · PMID 36705879 · DOI 10.1007/s11912-023-01361-0
5. DNA Damage and Activation of cGAS/STING Pathway Induce Tumor Microenvironment Remodeling.
   Shen R, Liu D, Wang X, Guo Z, et al · · 2021 · cited 48× · PMID 35265630 · DOI 10.3389/fcell.2021.828657
6. Demystifying the cGAS-STING pathway: precision regulation in the tumor immune microenvironment.
   Wang Q, Yu Y, Zhuang J, Liu R, et al · · 2025 · cited 27× · PMID 40506729 · DOI 10.1186/s12943-025-02380-0
7. Delivery of STING agonists for cancer immunotherapy.
   Wang J, Meng F, Yeo Y. · · 2024 · cited 27× · PMID 38461748 · DOI 10.1016/j.copbio.2024.103105
8. Plasmacytoid dendritic cells at the forefront of anti-cancer immunity: rewiring strategies for tumor microenvironment remodeling.
   Monti M, Ferrari G, Gazzurelli L, Bugatti M, et al · · 2024 · cited 22× · PMID 39020402 · DOI 10.1186/s13046-024-03121-9