NCT01278758

A Multi-center, Open-label, Dose-escalation Study to Assess the Pharmacokinetics of Intravenous ASA404 in Adult Advanced Cancer Patients With Impaired Renal Function and With Normal Renal Function

Terminated Phase 1 Last updated 6 December 2020

What this trial tests

Phase 1 trial testing ASA404, DMXAA or DXAA in Metastatic Cancer in 7 participants. Terminated before completion.

Timeline

1 March 2010

Primary endpoint
1 November 2010

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	7
Start date	1 March 2010
Primary completion	1 November 2010
Sites	4 locations across United States

Drugs / interventions tested

• ASA404, DMXAA or DXAA — full drug profile →

Conditions studied

• Metastatic Cancer — all drugs for Metastatic Cancer →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Metastatic Cancer. 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 months

Sponsor's own description

The purpose of this study is to evaluate the safety and pharmacokinetics of ASA404 in patients with refractory or relapsed metastatic cancer with impaired renal function and with normal renal function. It is very possible that patients with renal impairment will show differences in renal excretion of parent ASA404 and its metabolites, warranting a study that leads to a better pharmacokinetic assesssment in this population.

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. 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
6. 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
7. Immune Regulation of the cGAS-STING Signaling Pathway in the Tumor Microenvironment and Its Clinical Application.
   Pu F, Pu F, Chen F, Liu J, et al · · 2021 · cited 22× · PMID 33688199 · DOI 10.2147/ott.s298958
8. cGAS-STING pathway targeted therapies and their applications in the treatment of high-grade glioma.
   Tripathi S, Najem H, Mahajan AS, Zhang P, et al · · 2022 · cited 13× · PMID 36324813 · DOI 10.12688/f1000research.125163.1