Clinical trial NCT02393209 (phase 1/phase 2, status: terminated)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: docetaxel, tak-117
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    lack of efficacy in combination.
  
Eligibility criteria:

        Inclusion Criteria

          -  Has a histologically and/or cytologically confirmed diagnosis of NSCLC (squamous or
             nonsquamous).

             - For Phase 2 of the study, 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 of the study:

               -  Participants must have 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 (PD).

               -  A drug provided as maintenance therapy following cytotoxic chemotherapy will be
                  considered to be part of that regimen.

               -  Participants who received prior therapy with paclitaxel as a part of the
                  platinum-based doublet front-line regimen without PD on therapy.

               -  Participants who, after the front-line, platinum-based, non-docetaxel containing
                  chemotherapy, have been treated with 1 line of nivolumab or other
                  immune-checkpoint inhibitors but progressed on or after the therapy.

               -  For Phase 1b of the study: Participants who have experienced failure of multiple
                  lines of prior chemotherapy are eligible.

               -  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 1
             highly effective method and 1 additional effective (barrier) method of contraception,
             at the same time, from the time of signing the informed consent through 30 days (or
             longer, as mandated by local labeling) after the last dose of study drug, or agree to
             practice true abstinence.

          -  Female participants must agree to not donate eggs (ova) during the course of this
             study and for 30 days after receiving their last dose of TAK-117 and, for docetaxel,
             for as long as is mandated by local labeling.

          -  Male participants agree to practice highly effective barrier contraception during the
             entire study treatment period and through 120 days after the last dose of TAK-117 and,
             for docetaxel, for as long as is mandated by local labeling, or agree to practice true
             abstinence.

          -  Male participants must agree to not donate sperm during the course of the study and
             for 120 days after receiving their last dose of TAK-117 and, for docetaxel, for as
             long as is mandated by local labeling.

          -  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.

          -  In the opinion of the investigator, the participant or legal guardian is capable of
             understanding and complying with protocol requirements for the duration of the study.

        Exclusion Criteria:

          -  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 participant 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 a condition that requires the concomitant use of any of the protocol-excluded
             medications, supplements, or food products during the course of the study .

          -  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 electrocardiogram (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, unless has completed definitive therapy, is not on steroids, has
             a stable neurologic status for at least 2 weeks after completion of the definitive
             therapy and steroids, and does 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 TAK-117 and, for docetaxel, for as long as is
             mandated by local labeling.

          -  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.

          -  Is unwilling or unable to abide by the requirements of the study.