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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00718380
First received: July 16, 2008
Last updated: July 13, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Solid Tumor
 Drug: ABT-869
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Safety tolerability assessment [ Time Frame: Weekly assessment for 3 weeks then every 3 weeks or more frequently as needed ] [ Designated as safety issue: Yes ]
  • Dose limiting toxicity determination [ Time Frame: Weekly assessment for the first 3 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic profile evaluation [ Time Frame: Day 1 and Day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Preliminary tumor response [ Time Frame: Every 6 week ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: September 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: ABT-869
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.
Other Name: ABT-869
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.
Other Name: ABT-869
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.
Other Name: ABT-869

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718380

Locations
Japan
Site Reference ID/Investigator# 6891
Tokyo, Japan
Sponsors and Collaborators
Abbott
Investigators
Study Director: Susumu Matsuki, BS Abbott Japan Co.,Ltd
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00718380     History of Changes
Other Study ID Numbers: M10-227
Study First Received: July 16, 2008
Last Updated: July 13, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 21, 2013