Know Cancer

forgot password

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

Phase 1
20 Years
75 Years
Not Enrolling
Solid Tumor

Thank you

Trial Information

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

Inclusion 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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety tolerability assessment

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Susumu Matsuki, BS

Investigator Role:

Study Director

Investigator Affiliation:

Abbott Japan Co.,Ltd


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

September 2008

Completion Date:

June 2012

Related Keywords:

  • Solid Tumor
  • Neoplasms