TAK-659 and Paclitaxel in Treating Patients With Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03756818|
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : March 11, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Solid Neoplasm KRAS Gene Mutation Ovarian Carcinoma Refractory Malignant Solid Neoplasm Refractory Ovarian Carcinoma||Drug: Paclitaxel Other: Pharmacokinetic Study Drug: Spleen Tyrosine Kinase Inhibitor TAK-659||Phase 1|
PRIMARY OBJECTIVES I. To define the maximum tolerated doses (MTD) of spleen tyrosine kinase inhibitor TAK-659 (TAK-659) and paclitaxel.
II. To define the safety profiles of the combination.
SECONDARY OBJECTIVES I. To evaluate clinical response signals to the combination. II. To analyze pharmacokinetic interactions between TAK-659 and paclitaxel. III. To assess predictive biomarkers (baseline molecular mutation status) and/or resistant pathways by comparing molecular signatures at baseline versus at time of relapse in patients who have achieved objective responses.
OUTLINE: This is a dose-escalation study of spleen tyrosine kinase inhibitor TAK-659 and paclitaxel.
Patients receive spleen tyrosine kinase inhibitor TAK-659 orally (PO) once daily (QD) and paclitaxel intravenously (IV) over approximately 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 28 days.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of TAK-659 and Paclitaxel in Patients With Advanced Solid Tumors|
|Actual Study Start Date :||March 5, 2019|
|Estimated Primary Completion Date :||February 24, 2022|
|Estimated Study Completion Date :||February 24, 2022|
Experimental: Treatment (TAK-659 and paclitaxel)
Patients receive spleen tyrosine kinase inhibitor TAK-659 PO QD and paclitaxel IV over approximately 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Pharmacokinetic Study
Drug: Spleen Tyrosine Kinase Inhibitor TAK-659
- Incidence of adverse events and serious adverse events assessed by NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 5.0 [ Time Frame: Up to 4 years ]Adverse events (clinical manifestations and laboratory tests) and serious adverse events will be assessed by clinical symptoms and laboratory values, evaluation of vital signs, and performance of physical exam with a special attention to treatment-related fatigue, gastrointestinal symptoms, cardiovascular events, myelosuppression, and neurotoxicity.
- Incidence and grade of adverse events assessed by NCI CTCAE version 5.0 [ Time Frame: Up to 4 years ]Will assess incidence and grade of adverse events (clinical manifestations and laboratory tests) with particular attention to >= grade 2 adverse events over time by dose.
- Maximum tolerated dose [ Time Frame: Up to 28 days ]Defined according to the 3+3 design. Deaths during the study will be documented.
- Dose-limiting toxicity [ Time Frame: Up to 28 days ]
- Categorization of response based on Response Evaluation Criteria in Solid Tumors 1.1 [ Time Frame: Up to 4 years ]A patient will be determined as having a response if he/she has complete response, partial response or stable disease for at least 4 months; a patient will be determined as a non-response if there is no evidence of response by 4 months during this study.
- Minimum detectable effect size [ Time Frame: Baseline up to 28 days post-treatment ]Will use the Wilcoxon signed-rank test to calculate the minimum detectable effect size on biomarker data and tumor response. A mixed model accounting for patient effects will be used to analyze longitudinal data (including biomarker data) over time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756818
|Contact: Siqing Fufirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Siqing Fu 713-563-0181|
|Principal Investigator: Siqing Fu|
|Principal Investigator:||Siqing Fu||M.D. Anderson Cancer Center|