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

Sponsors and Collaborators:	Abbott Abbott Japan Co.,Ltd
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00718380

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 I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open Label, Phase 1 Study Evaluating Pharmacokinetics, Safety and Tolerability of ABT-869 in Subjects With Solid Tumors

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 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 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	September 2008
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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 2: Experimental 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.
Group 3: Experimental 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.
Group 4: Experimental 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.

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

Contacts

Contact: Abbott Japan Clinical Trials Registration Desk

ABTJ-CTR@abbott.com

Locations

Japan, Metropolis
	Recruiting
Tokyo, Metropolis, Japan

Sponsors and Collaborators

Abbott

Abbott Japan Co.,Ltd

Investigators

Study Director:

Yutaka Yumamura

Abbott

More Information

Responsible Party:	Abbott ( Kazuhiko Sawa )
Study ID Numbers:	M10-227
Study First Received:	July 16, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00718380
Health Authority:	Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on January 13, 2009