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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Solid Tumor

Treatments: Drug: ABT-869

Study type: Interventional

Funder types: Industry

Identifiers

NCT00718380

M10-227

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 4 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: ABT-869

Group 2

Experimental group

Description:

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

Treatment:

Drug: ABT-869

Group 3

Experimental group

Description:

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

Treatment:

Drug: ABT-869

Group 4

Experimental group

Description:

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

Treatment:

Drug: ABT-869