Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03430882 : TAK228 With Carbo and Taxol in Advanced Malignancies
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

1. Male or female patients 18 years or older.

2. Patients must have a diagnosis of a solid tumor malignancy and is refractory to
standard therapies who have relapsed after standard therapy, or whose cancers have no
standard therapy.

3. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance
status <=1.

4. 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 effective method of contraception and 1 additional effective (barrier)
method, at the same time, from the time of signing the informed consent through 90
days (or longer as mandated by local labeling [e.g., USPI, SmPC, etc,]) 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 patient. (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.)

5. Continued from Inclusion Criteria # 4: Male patients, even if surgically sterilized
(i.e., status post-vasectomy), who: agree to practice highly effective barrier
contraception during the entire study treatment period and through 120 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 patient. (Periodic abstinence [e.g.,
calendar, ovulation, symptothermal, postovulation methods for the female partner],
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 sperm during the course of this study or within 120 days after receiving their
last dose of study drug.

6. Screening clinical laboratory values as specified below: a) Bone marrow reserve
consistent with: absolute neutrophil count (ANC) >/= 1.5 x 10^9/L; platelet count >/=
100 x 10^9/L; hemoglobin >/= 9 g/dL without transfusion within 1 week preceding study
drug administration b) Hepatic: total bilirubin transaminases (aspartate aminotransferase/serum glutamic oxaloacetic
transaminase-AST/SGOT and alanine aminotransferase/serum glutamic pyruvic
transaminase-ALT/SGPT) Renal: creatinine clearance >/=50 mL/min based either on Cockcroft-Gault estimate or
based on urine collection (12 or 24 hour); d) Metabolic: Glycosylated hemoglobin
(HbA1c)<7.0%, fasting serum glucose ( mg/dL

7. Ability to swallow oral medications.

8. Voluntary written consent must be given before performance of any study related
procedure not part of standard medical care, with the understanding that consent may
be withdrawn by the patient at any time without prejudice to future medical care.

9. Patients who have a history of brain metastasis are eligible for the study provided
that all the following criteria are met: a) Brain metastases which have been treated
b) No evidence of disease progression for >/= 3 months before the first dose of study
drug. c) No hemorrhage after treatment d) Off-treatment with dexamethasone for 4 weeks
before administration of the first dose of TAK-228 e) No ongoing requirement for
dexamethasone or anti-epileptic drugs.

10. Patients must have evaluable or measurable disease by Response Evaluation Criteria in
Solid Tumors (RECIST) 1.1 criteria.

11. Patients must be 4 weeks beyond previous treatment of any chemotherapy or
radiotherapy, and must have recovered to toxicity. Exception: Patients may have received palliative low dose radiotherapy to
the limbs 1-4 weeks before this therapy provided pelvis, sternum, scapulae, vertebrae,
or skull were not included in the radiotherapy field. Patients who have received
non-chemotherapeutic biological agents will need to wait at least 5 half-lives or 4
weeks, whichever is shorter, from the last day of treatment of non-chemotherapeutic
biological agents.

Exclusion Criteria:

1. Carboplatin or Paclitaxel exposure within past 6 months

2. Central nervous system (CNS) metastasis.

3. Other clinically significant co-morbidities, such as uncontrolled pulmonary disease,
active central nervous system disease, active infection, or any other condition that
could compromise the patient's participation in the study.

4. Known human immunodeficiency virus infection.

5. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C
infection.

6. Any serious medical or psychiatric illness that could, in the investigator's opinion,
potentially interfere with the completion of treatment according to this protocol.

7. Diagnosed or treated for another malignancy within 2 years before administration of
the first dose of study drug, or previously diagnosed with another malignancy and have
any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma
in situ of any type are not excluded if they have undergone complete resection.

8. Breast feeding or pregnant.

9. Treatment with any investigational products within 4 weeks before the first dose of
study drug.

10. Previous treatment with dual PI3K/mTOR inhibitors, TORC1/2 inhibitors or TORC1
inhibitors.

11. Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI
disease, or for an unknown reason that may alter the absorption of TAK-228. In
addition, patients with enteric stomata are also excluded.

12. History of any of the following within the last 6 months before administration of the
first dose of the drug: a) Ischemic myocardial event, including angina requiring
therapy and artery revascularization procedures b) Ischemic cerebrovascular event,
including transient ischemic attack and artery revascularization procedures c)
Requirement for inotropic support (excluding digoxin) or serious (uncontrolled)
cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or
ventricular tachycardia) d) Placement of a pacemaker for control of rhythm e) New York
Heart Association (NYHA) Class III or IV heart failure f) Pulmonary embolism.

13. Significant active cardiovascular or pulmonary disease including: a) Uncontrolled
hypertension (i.e., systolic blood pressure >180 mm Hg, diastolic blood pressure > 95
mm Hg). Use of anti-hypertensive agents to control hypertension before Cycle1 Day 1 is
allowed. b) Pulmonary hypertension c) Uncontrolled asthma or O2 saturation < 90% by
arterial blood gas analysis or pulse oximetry on room air d) Significant valvular
disease; severe regurgitation or stenosis by imaging independent of symptom control
with medical intervention, or history of valve replacement e) Medically significant
(symptomatic) bradycardia f) History of arrhythmia requiring an implantable cardiac
defibrillator g) Baseline prolongation of the rate-corrected QT interval (QTc) (e.g.,
repeated demonstration of QTc interval > 480 milliseconds, or history of congenital
long QT syndrome, or torsades de pointes).

14. Poorly controlled diabetes mellitus defined as glycosylated hemoglobin (HbA1c) > 7%;
patients with a history of transient glucose intolerance due to corticosteroid
administration may be enrolled in this study if all other inclusion/exclusion criteria
are met.

15. Patients receiving systemic corticosteroids (either IV or oral steroids, excluding
inhalers or low-dose hormone replacement therapy) within 1 week before administration
of the first dose of study drug.

16. Daily or chronic use of a proton pump inhibitor (PPI) and/or having taken a PPI within
7 days before receiving the first dose of study drug.

17. Patients with hypersensitivity or other allergic reaction to platinum chemotherapy.

18. Patients with hypersensitivity or other allergic reaction to taxanes.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03430882      |      Link to official Clinicaltrials.gov listing
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