A Phase 1b/Adaptive Phase 2 Study of Docetaxel With or Without MLN1117in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
- Conditions
- non-small cell lung cancer (NSCLC)MedDRA version: 19.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-004281-25-IT
- Lead Sponsor
- MILLENNIUM PHARMACEUTICALS, INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 155
•Has a histologically and/or cytologically confirmed diagnosis of NSCLC (squamous or nonsquamous).
•For Phase 2, has a diagnosis of mixed squamous and nonsquamous (or adenosquamous) NSLC.
•Has locally advanced or metastatic disease (Stage IIIb or Stage IV) with radiographically or clinically evaluable lesions.
•Has experienced failure of at least 1 prior chemotherapy regimen.
•For Phase 2, has received 1 prior platinum-based chemotherapy regimen (excluding a docetaxel containing regimen) for advanced or metastatic (Stage IIIb or Stage IV) disease followed by documented progressive disease.
•For Phase 2, has archived or fresh tumor biopsy samples obtained during screening sufficient for genotyping.
•Has adequate organ function, before the first dose of study drug.
•Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
•Female participants who are postmenopausal for at least 1 year before the screening visit or are surgically sterile, or are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 30 days after the last dose of study drug, or agree to practice true
abstinence.
•Male participants agree to practice 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.
•Has suitable venous access for the study-required blood sampling.
•Has recovered (ie, <= Grade 1 toxicity or eligibility per this protocol is met) from the reversible effects of prior anticancer therapy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
•Previous treatment with a PI3K or AKT inhibitor.
•Prior cancer therapy or other investigational therapy within 2 weeks before the first administration of study drug or failed to recover from the reversible effects of prior anticancer therapies. For prior therapies with a half-life longer than 3 days, the interval must be at least 28 days before
the first administration of study drug, and the patient must have documented progressive disease.
•Has poorly controlled diabetes mellitus defined as HbA1c > 6.5%.
•Has taken strong inhibitors or strong inducers of CYP3A4 within 14 days before the first dose of study drug.
•Has taken histamine-H2 receptor antagonists and/or neutralizing antacids within 24 hours before the first administration of study drug.
•Has taken proton pump inhibitors within 7 days before the first administration of study drug.
•Has any clinically significant co-morbidities.
•Has 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 ECG evidence of acute ischemia or active conduction system abnormalities,
Fridericia's corrected QT interval > 475 milliseconds (msec) (males) or > 450 msec (females) on a 12-lead ECG during the Screening period, or 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.
•Has known, previously diagnosed human immunodeficiency virus infection or active chronic hepatitis B or C.
•Has brain metastasis, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids, and do not have neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
•Has active secondary malignancy that requires treatment.
•Has any serious medical or psychiatric illness, including drug or alcohol abuse.
•Male participants who intend to donate sperm during the course of this study or 120 days after receiving their last dose of study drug.
•Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive
urine pregnancy test on Day 1 before administration of the first dose of study drug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method