Clinical trial NCT00718380: A Phase 1 Study of ABT-869 in Subjects With Solid Tumors
Official title: An Open Label, Phase I Study Evaluating Pharmacokinetics, Safety, and Tolerability of ABT-869 in Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-07-18
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Safety tolerability assessment
timeFrame: Weekly assessment for 3 weeks then every 3 weeks or more frequently as needed
measure: Dose limiting toxicity determination
timeFrame: Weekly assessment for the first 3 weeks
measure: Pharmacokinetic profile evaluation
timeFrame: Day 1 and Day 15
Secondary outcomes:
measure: Preliminary tumor response
timeFrame: Every 6 week
Other outcomes:
Locations:
Study officials:
affiliation: Abbott Japan Co.,Ltd
name: Susumu Matsuki, BS
role: STUDY_DIRECTOR
References:
citation: Asahina H, Tamura Y, Nokihara H, Yamamoto N, Seki Y, Shibata T, Goto Y, Tanioka M, Yamada Y, Coates A, Chiu YL, Li X, Pradhan R, Ansell PJ, McKeegan EM, McKee MD, Carlson DM, Tamura T. An open-label, phase 1 study evaluating safety, tolerability, and pharmacokinetics of linifanib (ABT-869) in Japanese patients with solid tumors. Cancer Chemother Pharmacol. 2012 Jun;69(6):1477-86. doi: 10.1007/s00280-012-1846-6. Epub 2012 Mar 2.