Skip to main content
OpenTrials
Completed

NCT Number: NCT00116610

Picoplatin as Second-Line Therapy for Patients With Small Cell Lung Cancer

This is a Phase II research study that is designed for patients who have small cell lung cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a new platinum-based agent that is currently under investigation, in 21-day cycles.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Disease Attributes Hypersensitivity Immune System Diseases Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tom Baker Cancer Center, Calgary, Alberta, Canada

Loading trial locations.

About this study

Platinum drugs work by binding to DNA and preventing the rapid cell division of tumors. However, many tumors demonstrate a resistance to platinum drugs. Results from preclinical studies indicate that picoplatin (previously called AMD473 or ZD0473) may be able to overcome or partially overcome platinum resistance. More than 500 patients have received picoplatin in previous Phase I or Phase II clinical trials.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main inclusion criteria:

  • Diagnosis of small cell lung cancer.
  • Patients must have had one prior chemotherapy regimen which must have included either cisplatin or carboplatin.

[Additional eligibility criteria apply.]

Exclusion criteria

  • Prior radiotherapy that included > 30% of the bone marrow (i.e., the whole of the pelvis or half of the spine).
  • Significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom.
  • Significant heart disease.
  • Uncontrolled, untreated, unstable, or symptomatic brain tumors or central nervous system disease.
  • Grade 2+ peripheral neuropathy (a condition caused by damage to the nerves in the peripheral nervous system).

[Additional exclusion criteria apply.]

Treatment and study plan

picoplatin

Drug

Primary outcomes

  1. Efficacy and safety (outcomes will be measured approximately 1 year after the last subject has been treated)

Sponsors and collaborators

Lead sponsor

Poniard Pharmaceuticals

Industry

Registry information

Official study title

A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Jun 30, 2005
Registry last updated
Jan 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.