TAK228 With Carbo and Taxol in Advanced Malignancies
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|ClinicalTrials.gov Identifier: NCT03430882|
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : September 3, 2018
The goal of this clinical research study is to find the highest tolerable dose of the combination of TAK-228, carboplatin, and paclitaxel that can be given to patients with advanced cancer. The safety of the drug combination will also be studied.
This is an investigational study. TAK-228 is not FDA approved or commercially available. TAK-228 is currently being used for research purposes only. Carboplatin and paclitaxel are both FDA approved and commercially available for the treatment of various cancers. The combination of carboplatin and paclitaxel is frequently used in clinical practice. The combination of these drugs with TAK-228 to treat advanced cancer is considered investigational.
The study doctor can explain how the study drugs are designed to work.
Up to 50 participants will take part in this study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Breast Malignant Neoplasms of Bone and Articular Cartilage Malignant Neoplasms of Digestive Organs Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System Malignant Neoplasms of Female Genital Organs Malignant Neoplasms of Ill-defined Secondary and Unspecified Sites Malignant Neoplasms of Independent (Primary) Multiple Sites Malignant Neoplasms of Lip Oral Cavity and Pharynx Malignant Neoplasms of Male Genital Organs Malignant Neoplasms of Mesothelial and Soft Tissue Malignant Neoplasms of Respiratory and Intrathoracic Organs Malignant Neoplasms of Thyroid and Other Endocrine Glands Malignant Neoplasms of Urinary Tract Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic||Drug: TAK-228 Drug: Paclitaxel Drug: Carboplatin||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of TAK-228 (MLN0128) in Combination With Carboplatin Plus Paclitaxel in Patients With Advanced Malignancies|
|Actual Study Start Date :||March 12, 2018|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2024|
Experimental: TAK-228 + Paclitaxel + Carboplatin
Participants take TAK-228 by mouth at about the same time each day on Days 2-4, 9-11, and 16-18 of Cycles 1-6. Participants then take TAK-228 on Day 1 of Cycles 7 and beyond.
Participants receive Carboplatin by vein over about 60 minutes on Day 1 of Cycles 1-6.
Participants receive Paclitaxel by vein over about 3 hours on Days 1, 8, and 15 of Cycles 1-6.
Each cycle is 21 days.
Dose Escalation Starting Dose of TAK-228: 2 mg by mouth at about the same time each day on Days 2-4, 9-11, and 16-18 of Cycles 1-6. Participant then takes TAK-228 on Day 1 of Cycles 7 and beyond.
Dose Expansion Starting Dose of TAK-228: Maximum tolerated dose from Dose Escalation Phase.
Dose Escalation Starting Dose of Paclitaxel: 40 mg/m2 by vein weekly for 6, 21 day cycles.
Dose Expansion Starting Dose of Paclitaxel: Maximum tolerated dose from Dose Escalation Phase.
Other Name: Taxol
Dose Escalation Starting Dose of Carboplatin: AUC 5 by vein on Day of cycles 1-6.
Dose Expansion Starting Dose of Carboplatin: Maximum tolerated dose from Dose Escalation Phase.
Other Name: Paraplatin
- Maximum Tolerated Dose (MTD) of TAK-228 in Combination With Carboplatin Plus Paclitaxel in Patients With Advanced Malignancies [ Time Frame: Start of study drug up to 21 days ]MTD is the highest dose level in which 6 patients have been treated with at most 1 experiencing dose limiting toxicity (DLT). Toxicities graded using NCI CTCAE v4.0 toxicity criteria.
- Clinical Response of TAK-228 in Combination With Carboplatin Plus Paclitaxel in Patients With Advanced Malignancies [ Time Frame: Start of drug combination up to 6 months ]Categorization of response based on RECIST v1.1.
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): NCT03430882
|Contact: Vivek Subbiah, MDemail@example.com|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Vivek Subbiah, MD||M.D. Anderson Cancer Center|