Clinical trial · Interventional
Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
NCT00516672CI-TRIAL-00030301completedPhase 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)
This is a two part phase I study in Japanese patients that will determine the safety, tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination with lapatinib.
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 |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Pazopanib monotherapy or in combination with lapatinib
- interventionNames
- Drug: pazopanib
- Drug: Lapatinib
Primary outcomes (1)
- measure
- Safety and tolerability
- timeFrame
- before and after taking the study medications
- description
- The safety and tolerability endpoints will consist of the evaluation of adverse events (AEs), and changes in vital signs and laboratory values.
Secondary outcomes (2)
- measure
- Pharmacokinetics
- timeFrame
- over a 24 hour period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion criteria: * Signed informed consent. * Histologically or cytologically confirmed diagnosis of advanced solid tumor. * Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study. * ECOG performance status of 0 or 1. * Adequate bone marrow reserve and hepato-renal function. * Able to swallow and retain oral medication. * For combo part, left ventricular ejection fraction within normal range or above 50%. Exclusion criteria: * Prior treatment with pazopanib, and with lapatinib for combo part. * Clinically significant gastrointestinal abnormalities. * Sevier diseases or conditions other than cancer. * Poorly controlled hypertension. * Use of warfarin for therapeutic anticoagulation. * Use of other anti-angiogenesis agents, and other ErbB inhibitors for combo part. * Unresolved and/or unstable toxicities * Pregnant or lactating females
References
Publications (1)
- DERIVEDInada-Inoue M, Ando Y, Kawada K, Mitsuma A, Sawaki M, Yokoyama T, Sunakawa Y, Ishida H, Araki K, Yamashita K, Mizuno K, Nagashima F, Takekura A, Nagamatsu K, Sasaki Y. Phase 1 study of pazopanib alone or combined with lapatinib in Japanese patients with solid tumors. Cancer Chemother Pharmacol. 2014 Apr;73(4):673-83. doi: 10.1007/s00280-014-2374-3. Epub 2014 Jan 24. PMID 24464355