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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00718380
• Other study ID #: M10-227
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2008
• Last updated: November 17, 2017
• Start date: September 2008
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Solid Tumor

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & 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 phar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety tolerability assessment		Weekly assessment for 3 weeks then every 3 weeks or more frequently as needed
Primary	Dose limiting toxicity determination		Weekly assessment for the first 3 weeks
Primary	Pharmacokinetic profile evaluation		Day 1 and Day 15
Secondary	Preliminary tumor response		Every 6 week