Clinical trial · Interventional
A Phase 1 Study of ABT-869 in Subjects With Solid Tumors
An Open Label, Phase I Study Evaluating Pharmacokinetics, Safety, and Tolerability of ABT-869 in Subjects With Solid Tumors
NCT00718380CI-TRIAL-00030472completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABT-869 | Drug | Linifanib | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Dose escalation from Open label 0.05 to 0.25 mg/kg once a day dosing for 21 days
- interventionNames
- Drug: ABT-869
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Open label 0.10 mg/kg once a day dosing after safety evolution of Group 1
- interventionNames
- Drug: ABT-869
- type
- EXPERIMENTAL
- label
- Group 3
- description
- Open label 0.20 mg/kg once a day dosing after safety evolution of Group 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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).
References
Publications (1)
- RESULTAsahina 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