TAK-659 and Paclitaxel in Treating Patients With Advanced Solid Tumors

NCT03756818 | Completed Phase 1 FDA Drug

• 3 other identifiers: 2017-0422NCI-2018-02665P30CA016672
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial studies the best dose and side effects of TAK-659 and paclitaxel in treating patients with advanced solid tumors. TAK-659 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving TAK-659 and paclitaxel may work better in treating patients with advanced solid tumors.

Conditions

Advanced Malignant Solid Neoplasm; Ovarian Carcinoma; Refractory Malignant Solid Neoplasm; Refractory Ovarian Carcinoma

Outcome Measures

Primary Outcomes (1)

• To define the maximum tolerated doses (MTD) of TAK-659 and paclitaxel

  This is a dose-escalation study of mivavotinib and paclitaxel

  Up to 4 years

Study Arms (1)

Treatment (mivavotinib and paclitaxel)

EXPERIMENTAL

Patients receive mivavotinib PO QD and paclitaxel IV over approximately 1 hour on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Mivavotinib; Drug: Paclitaxel; Other: Pharmacokinetic Study

Interventions

Mivavotinib DRUG

Given PO

Also known as: Spleen Tyrosine Kinase Inhibitor TAK659, syk Inhibitor TAK-659, syk Inhibitor TAK659, syk-Inhibitor TAK-659, syk-Inhibitor TAK659, TAK-659 Free Base, TAK659 Free Base

Treatment (mivavotinib and paclitaxel)

Paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Treatment (mivavotinib and paclitaxel)

Pharmacokinetic Study OTHER

Correlative studies

Also known as: PHARMACOKINETIC, PK Study

Treatment (mivavotinib and paclitaxel)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients have advanced malignancy, including but not limited to high-grade epithelial ovarian cancer or cancer harboring K-RAS mutation, either refractory to standard therapy or for which no effective standard therapy is available
• Patients must have measurable or evaluable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 and life expectancy of greater than 3 months and/or other performance status of 0 to 1
• Female patients who:
• Are postmenopausal for at least 1 year before the screening visit, OR
• Are surgically sterile, OR
• If they are of childbearing potential, agree to practice 1 highly effective method of contraception and one additional effective (barrier) method at the same time, from the time of signing the informed consent through 180 days after the last dose of study drug, OR
• Agree to practice true abstinence, when is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together)
• Agree not to donate eggs (ova) during the course of this study or 180 days after receiving their last dose of study drug
• Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:
• Agree to practice effective barrier contraception during the entire study treatment period and through 180 days after the last dose of study drug, or
• Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \[eg, calendar, ovulation, symptothermal, postovulation methods for the female partner\] and withdrawal are not acceptable methods of contraception. Female and male condoms should not be used together.)
• Agree not to donate sperm during the course of this study or within 180 days after receiving their last dose of study drug
• Absolute neutrophil count (ANC) \>= 1,500/uL
• Platelet count \>= 100,000/uL (red blood cell count \[RBC\] and platelet transfusion allowed \>= 14 days before assessment)

You may not qualify if:

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), or history of myocardial infarction, unstable angina, stroke or transient ischemic attack within 6 months prior to study enrollment
• Active brain metastases or leptomeningeal metastases
• History of drug-induced pneumonitis requiring treatment with steroids; history of idiopathic pulmonary fibrosis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted
• Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 before first dose of study drug
• Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol
• Life-threatening illness unrelated to cancer that could, in the investigator's opinion, make the patient not appropriate for this study
• Known human immunodeficiency virus (HIV) positive
• Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection
• Any treatment specific for systemic tumor control within 3 weeks prior to the initiation of the study drugs; or within 2 weeks if cytotoxic agents were given weekly (within 6 weeks for nitrosoureas or mitomycin C), or within 5 half-lives for targeted agents with half-lives and pharmacodynamic effects lasting less than 4 days (that includes but is not limited to erlotinib, sorafenib, sunitinib, bortezomib, and other similar agents), or failure to recover from toxic effects of any therapy prior to the study drug treatment
• Any clinically significant comorbidities, such as uncontrolled pulmonary disease, known impaired cardiac function or clinically significant cardiac disease (specified below), active central nervous system (CNS) disease, active infection, or any other condition that could compromise the patient's participation in the study. Patients with any of the following cardiovascular conditions are excluded:
• Acute myocardial infarction within 6 months before starting study drug
• Current or history of New York Heart Association Class III or IV heart failure
• Evidence of current, uncontrolled cardiovascular conditions including cardiac arrhythmias, angina, pulmonary hypertension, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
• Fridericia corrected QT interval (QTcF) \> 450 milliseconds (msec) (men) or \> 475 msec (women) on a 12-lead electrocardiogram (ECG) during the screening period
• Abnormalities on 12-lead ECG including, but not limited to, changes in rhythm and intervals that, in the opinion of the investigator, are considered to be clinically significant

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

TAK-659; Paclitaxel; Taxes; Pharmacogenomic Variants

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Polymorphism, Genetic; Genetic Variation; Genetic Phenomena

Study Officials

• Siqing Fu

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: March 5, 2019
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

US (1)