NCT00177281

A Phase I Study to Evaluate the Safety and Pharmacokinetics of S-CKD602 in Patients With Advanced Malignancies

Completed Phase 1 Last updated 18 December 2013

What this trial tests

Phase 1 trial testing S CKD602 in Cancer in 45 participants. Completed in 1 May 2006.

Timeline

1 September 2003

Primary endpoint
1 May 2006

1 May 2006

Quick facts

Lead sponsor	University of Pittsburgh
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	1 September 2003
Primary completion	1 May 2006
Estimated completion	1 May 2006
Sites	1 location across United States

Drugs / interventions tested

• S CKD602 — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

University of Pittsburgh

Who can join

18 and older, any sex, with 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 determine the maximum tolerated dose of S CKD602 when given every three weeks.
• To determine the incidence and severity of toxicity of S CKD602 when given every three weeks.

Sponsor's own description

The purpose of this research study is to evaluate a new anti-cancer drug called S CKD602, developed by ALZA Corporation. The drug is investigational and not approved by the Food and Drug administration (FDA). The side effects (the way the drug acts in your body) and the effect it has on your disease will be studied.

Publications & conference data

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

1. Lipid-Based Nanoparticles in the Clinic and Clinical Trials: From Cancer Nanomedicine to COVID-19 Vaccines.
   Thi TTH, Suys EJA, Lee JS, Nguyen DH, et al · · 2021 · cited 317× · PMID 33918072 · DOI 10.3390/vaccines9040359
2. Chemistry and Art of Developing Lipid Nanoparticles for Biologics Delivery: Focus on Development and Scale-Up.
   John R, Monpara J, Swaminathan S, Kalhapure R. · · 2024 · cited 31× · PMID 38276502 · DOI 10.3390/pharmaceutics16010131