NCT01278849

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

Terminated Phase 1 Last updated 6 December 2020

What this trial tests

Phase 1 trial testing ASA404 in Histologically-proven and Radiologically-confirmed Solid Tumors in 5 participants. Terminated before completion.

Timeline

1 January 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	5
Start date	1 January 2010
Primary completion	1 November 2010
Sites	4 locations across Italy, New Zealand

Drugs / interventions tested

• ASA404 — full drug profile →

Conditions studied

• Histologically-proven and Radiologically-confirmed Solid Tumors — all drugs for Histologically-proven and Radiologically-confirmed Solid Tumors →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Histologically-proven and Radiologically-confirmed Solid Tumors. 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.

• (Core Phase)To evaluate the PK of a single intravenous dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired hepatic function compared to matching patients with normal hepatic function
  Time frame: 18 months

Sponsor's own description

This study is designed to obtain pharmacokinetic data following a single-dose 20-minute i.v. administration of ASA404 (900, 1200, or 1800 mg/m2) in adult cancer patients with varying degrees of hepatic impairment. The study will be carried out in cancer volunteer patients (utilizing controls with normal hepatic function) who will be assigned to four hepatic impairment groups according to their pre-dose (Day-1) and total bilirubin level. The study will consist of two phases, a (Core Phase) that will evaluate the pharmacokinetics of a single i.v. dose (900, 1200 and 1800 mg/m2) of ASA404 in adult cancer patients with impaired hepatic function, and compared to controls with normal hepatic function. The assessments will be done on the safety and tolerability of that single dose in adult cancer patients with impaired hepatic function and compared to controls with normal hepatic function. The Extension Phase will consist of assessing the safety and tolerability of ASA404 at the same three doses in combination with a sponsor-approved taxane-based regimen in adult cancer patients with impaired hepatic function and compared to controls with normal hepatic function.

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