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OpenTrials
Completed

NCT Number: NCT00350831

Study of XL820 Given Orally Daily to Subjects With Solid Tumors

The purpose of this study is to assess the safety and tolerability of the KIT inhibitor XL820 when given orally daily to adults with advanced solid tumors.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject has a histologically confirmed solid tumor that is metastatic or unresectable for which known effective measures do not exist or are no longer effective, and there are no known therapies to prolong survival
  • Subject is at least 18 years old
  • Subject has ECOG performance status ≤ 2
  • Subject has a life expectancy of > 3 months
  • Subject has adequate organ and marrow function
  • In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level ≥ 20 ug/dL (552 nmol/L) 30-90 minutes after injection of ACTH
  • Subject has given written informed consent
  • Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study.
  • Female subjects of childbearing potential must have a negative pregnancy test at screening.

Exclusion criteria

  • Subject has received anticancer treatment within 30 days before the first dose of XL820, or has not recovered to grade ≤ 1 from adverse events due to agents administered more than 30 days earlier
  • Subject has received radiation to ≥ 25% of his/her bone marrow within 30 days of XL820 treatment
  • Subject has received an investigational agent within 30 days of the first dose of XL820
  • Subject has known brain metastases
  • Subject has known uncontrolled intercurrent illness
  • Subject is pregnant or lactating
  • Subject is known to be positive for HIV
  • Subject has a known allergy or hypersensitivity to any of the components of the XL820 formulation

Treatment and study plan

XL820

Drug

Primary outcomes

  1. maximum tolerated dose

  2. safety and tolerability

Secondary outcomes

  1. plasma pharmacokinetics

  2. pharmacodynamic effects

  3. long-term safety and tolerability

Sponsors and collaborators

Lead sponsor

Exelixis

Industry

Registry information

Official study title

A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of the KIT Inhibitor XL820 Administered Orally Daily to Subjects With Solid Tumors

Important dates

Study start
2006
First posted
Jul 11, 2006
Registry last updated
Aug 18, 2008

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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