A phase 2 study of vatalanib in metastatic melanoma patients

Natalie Cook1, Bristi Basu, Swethajit Biswas

  • 1Cambridge University Hospitals NHS Foundation Trust (Addenbrookes Hospital), Cambridge, UK.

European Journal of Cancer (Oxford, England : 1990)
|August 31, 2010
PubMed
Abstract

Insights

Vatalanib, an oral tyrosine kinase inhibitor, showed a 35% tumor control rate in metastatic melanoma patients. However, overall survival was disappointing, indicating limited efficacy for this treatment.

Area of Science:

  • Oncology
  • Pharmacology
  • Clinical Trials

Background:

  • Investigated vatalanib (PTK787/ZK222584), an oral tyrosine kinase inhibitor targeting VEGFR 1, 2, and 3.
  • Focused on patients with metastatic melanoma.

Purpose of the Study:

  • To evaluate the efficacy and safety of vatalanib in metastatic melanoma.
  • To determine tumor control rate and survival outcomes.

Main Methods:

  • Phase 2 clinical trial with Fleming's single-stage design.
  • Adult patients with metastatic melanoma, WHO Performance Status 0-2, and adequate organ function were enrolled.
  • Treatment continued until disease progression.

Main Results:

  • Tumor control rate (CR+PR+SD) at 16 weeks was 35%.
  • Only one patient achieved an objective response.
  • Median progression-free survival was 1.8 months; median overall survival was 6.5 months.

Conclusions:

  • Vatalanib demonstrated disease stabilization in a subset of patients.
  • The overall survival outcomes were disappointing, suggesting limited clinical benefit.

Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Drug Metabolism: Phase II Reactions01:14

Drug Metabolism: Phase II Reactions

Phase II reactions are essential for the detoxification and elimination of drugs from the body. These reactions involve the conjugation of parent drugs or their phase I metabolites with endogenous molecules, resulting in more hydrophilic drug conjugates. The primary conjugation reactions in this phase are sulfation and glucuronidation. Both sulfation and glucuronidation typically produce biologically inactive metabolites. However, in some cases involving prodrugs, active metabolites may be...
Treatment Resistent Cancers02:56

Treatment Resistent Cancers

Cancer is the second leading cause of death in the United States. A cancer cell is genetically unstable and hence can mutate faster. They can also modify their microenvironment and escape immune surveillance. The difficulties in treating cancer are further compounded by the emergence of rapid resistance to anticancer drugs. The most common ways to attain resistance in cancer cells include alteration in drug transport and metabolism, modification of drug target, elevated DNA damage response, or...