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

NCT00718380 | Completed Phase 1

• 1 other identifier: M10-227
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Safety tolerability assessment

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

• Dose limiting toxicity determination

  Weekly assessment for the first 3 weeks

• Pharmacokinetic profile evaluation

  Day 1 and Day 15

Secondary Outcomes (1)

• Preliminary tumor response

  Every 6 week

Study Arms (4)

Group 1

EXPERIMENTAL

Dose escalation from Open label 0.05 to 0.25 mg/kg once a day dosing for 21 days

Drug: ABT-869

Group 2

EXPERIMENTAL

Open label 0.10 mg/kg once a day dosing after safety evolution of Group 1

Drug: ABT-869

Group 3

EXPERIMENTAL

Open label 0.20 mg/kg once a day dosing after safety evolution of Group 2

Drug: ABT-869

Group 4

EXPERIMENTAL

Open label 0.25 mg/kg once a day dosing after safety evolution of Group 3

Drug: ABT-869

Interventions

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.

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AbbVie: lead

Related Publications (1)

• 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.

  PMID: 22382879 RESULT

MeSH Terms

Interventions

linifanib

Study Officials

• Susumu Matsuki, BS

  Abbott Japan Co.,Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2008
• First Posted: July 18, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 21, 2017

Record last verified: 2012-07