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

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ClinicalTrials.gov Identifier: NCT00718380
Recruitment Status : Completed
First Posted : July 18, 2008
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: ABT-869 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Phase I Study Evaluating Pharmacokinetics, Safety, and Tolerability of ABT-869 in Subjects With Solid Tumors
Study Start Date : September 2008
Primary Completion Date : June 2012
Study Completion Date : June 2012

Arm Intervention/treatment
Experimental: Group 1
Dose escalation from Open label 0.05 to 0.25 mg/kg once a day dosing for 21 days
Drug: ABT-869
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.
Experimental: Group 2
Open label 0.10 mg/kg once a day dosing after safety evolution of Group 1
Drug: ABT-869
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.
Experimental: Group 3
Open label 0.20 mg/kg once a day dosing after safety evolution of Group 2
Drug: ABT-869
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.
Experimental: Group 4
Open label 0.25 mg/kg once a day dosing after safety evolution of Group 3
Drug: ABT-869
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 Outcome Measures :
  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 Outcome Measures :
  1. Preliminary tumor response [ Time Frame: Every 6 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

    1. proteinuria CTC grade > 1 as measured by urinalysis and 24 hour urine collection
    2. diastolic blood pressure (BP) > 95 mmHg; or systolic blood pressure (BP) > 150 mmHg
    3. a history of or currently exhibits clinically significant cancer related events of bleeding
    4. LV Ejection Fraction < 50%
    5. received a cumulative dose of Anthracycline > 360 mg/m2 for treatment of cancer
    6. receiving therapeutic anticoagulation therapy
    7. having fractures except for chronic bone lesion due to bone metastases
  • The subject exhibits evidence of other clinically significant uncontrolled condition(s).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718380


Sponsors and Collaborators
AbbVie
Investigators
Study Director: Susumu Matsuki, BS Abbott Japan Co.,Ltd