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Completed

NCT Number: NCT00718380

A Phase 1 Study of ABT-869 in Subjects With Solid Tumors

The objective of this study is to evaluate the pharmacokinetics, safety and tolerability of ABT-869 in Japanese patients with solid tumors up to the Recommended Phase Two Dose that was determined in a previous the M04-710 study.

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Key information

Conditions

Solid Tumor

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects aged from 20 to 75 years and ECOG PS of 0-2 at screening.
  • Subject must have a solid tumor that is refractory to standard therapies or for which a standard effective therapy does not exist.
  • The subject must have adequate bone marrow, renal and hepatic function.
  • Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and up to six months following completion of therapy.
  • The subject must voluntarily sign and date an informed consent.

Exclusion criteria

  • The subject currently exhibits symptomatic or intervention indicated CNS metastasis.
  • The subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic or any investigational therapy within 4 weeks of enrollment or has not fully recovered from toxicity resulting from past treatment(s) that affects the assessments in this study at the enrollment.
  • The subject with the following conditions during screening assessment.
  • proteinuria CTC grade > 1 as measured by urinalysis and 24 hour urine collection
  • diastolic blood pressure (BP) > 95 mmHg; or systolic blood pressure (BP) > 150 mmHg
  • a history of or currently exhibits clinically significant cancer related events of bleeding
  • LV Ejection Fraction < 50%
  • received a cumulative dose of Anthracycline > 360 mg/m2 for treatment of cancer
  • receiving therapeutic anticoagulation therapy
  • having fractures except for chronic bone lesion due to bone metastases
  • The subject exhibits evidence of other clinically significant uncontrolled condition(s).

Treatment and study plan

ABT-869

Drug

2.5 mg or 10 mg tablet, Once a day, oral dose, dose per body weight (dose determined by group; 2.5mg or 10mg tablet) until evidence of uncontrolled unacceptable toxicity or disease progression. For more information, please see Arm Description.

Primary outcomes

  1. Safety tolerability assessment

    Time frame: Weekly assessment for 3 weeks then every 3 weeks or more frequently as needed

  2. Dose limiting toxicity determination

    Time frame: Weekly assessment for the first 3 weeks

  3. Pharmacokinetic profile evaluation

    Time frame: Day 1 and Day 15

Secondary outcomes

  1. Preliminary tumor response

    Time frame: Every 6 week

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

An Open Label, Phase I Study Evaluating Pharmacokinetics, Safety, and Tolerability of ABT-869 in Subjects With Solid Tumors

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jul 18, 2008
Registry last updated
Nov 21, 2017

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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