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Completed

NCT Number: NCT00420485

Dose-escalation Study of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis Investigative Site, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Advanced or metastatic cancer
  • 18 years and above

Exclusion criteria

  • Previous treatment with 4 or more cycles of carboplatin;
  • Previous treatment with 2 or more courses of nitrosourea or mitomycin;
  • Previous radiation therapy greater than or equal to 25% of the hematopoietic reserve;
  • Severe and/or uncontrolled medical conditions

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Gimatecan

Drug

Primary outcomes

  1. Presence of dose limiting toxicities in a 56-day treatment period

    Time frame: 56 days

Secondary outcomes

  1. safety and tolerability assessed by adverse events, serious adverse events

    Time frame: 112 days

  2. pharmacokinetics of gimatecan and its metabolites(s)

    Time frame: 91 days

  3. response rate assessed by anti-tumor activity

    Time frame: 112 days

  4. investigate tumor-specific mutations

    Time frame: 57 days

  5. Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC

    Time frame: 56 days

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Phase I Open-label, Multi-center Dose-escalation Study to Determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity of Gimatecan Administered in Two Different Schedules in Adult Patients With Advanced Solid Tumors

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jan 11, 2007
Registry last updated
Apr 19, 2013

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.

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