Clinical trial NCT01041235 (phase 1, status: completed)
Conditions: solid tumor, breast cancer, ovarian cancer, pancreatic cancer, non-small cell lung
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, C25.3
Drugs: ati-1123 (active drug = docetaxel)
SMILES: [H][C@@]12C[C@H](O)[C@@]3(C)C(=O)[C@H](O)C4=C(C)[C@H](C[C@@](O)([C@@H](OC(=O)C5=CC=CC=C5)[C@]3([H])[C@@]1(CO2)OC(C)=O)C4(C)C)OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Understand and sign a written IRB-approved informed consent form.

          -  Have a histologically confirmed solid tumor.

          -  Have progressive disease following standard/approved chemotherapy or have no
             appropriate alternative therapy available.

          -  Have one or more tumors measurable or evaluable as outlined by modified RECIST or
             evaluable by CT or MRI scan.

          -  Have an ECOG performance status of ≤ 2.

          -  Have a life expectancy of at least 3 months.

          -  Be ≥ 18 years old.

          -  Have a negative pregnancy test (if female of childbearing potential)

          -  Demonstrate acceptable hepatic function:

          -  Bilirubin ≤ upper limit of normal (ULN)

          -  AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN

          -  Demonstrate acceptable renal function:

          -  Serum creatinine ≤ 1.5 x ULN, OR calculated creatinine clearance ≥ 60 mL/min/1.73 m2
             for patients with creatinine levels above institutional normal (Calculated according
             to the Cockroft and Gault formula)

          -  Demonstrate acceptable hematologic status:

          -  Absolute neutrophil count ≥ 1500/mm3

          -  Platelet count ≥ 100,000/mm3 (measured within 72 hours prior to initial dose)

          -  Hemoglobin ≥ 9 g/dL

          -  Demonstrate acceptable coagulation status:

          -  PT or INR within 1.5x ULN

          -  PTT within 1.5x ULN

          -  Have recovered from prior treatments (eg, surgery, radiation, chemotherapy,
             investigational therapies) sufficiently prior to Day 1 so that, in the opinion of the
             Investigator and/or Medical Monitor, the protocol objectives would not be compromised.

          -  Agree to use an effective contraceptive method (hormonal or barrier method; or
             abstinence) for the duration of the study and for 30 days after the last dose (for men
             and women of child-producing potential).

        Exclusion Criteria:

          -  Have New York Heart Association Class III or IV cardiac disease, myocardial infarction
             within the past 6 months prior to Day 1, unstable arrhythmia, or evidence of ischemia
             on electrocardiogram (ECG).

          -  Have a seizure disorder requiring anticonvulsant therapy.

          -  Have active CNS metastasis. Patients with a history of CNS metastases will be eligible
             if they have been treated and are stable without symptoms for 4 weeks after completion
             of treatment, with image documentation required, and must be either off steroids or on
             stable dose of steroids for ≥ 1 week prior to enrollment.

          -  Have severe, chronic obstructive pulmonary disease with hypoxemia.

          -  Have active, uncontrolled bacterial, viral, or fungal infections requiring systemic
             therapy.

          -  Are pregnant or nursing.

          -  Have undergone radiation therapy, surgery, chemotherapy, or investigational therapy
             within 28 days prior to study entry (6 weeks for nitrosoureas or Mitomycin C).

          -  Are unwilling or unable to comply with procedures required in this protocol.

          -  Have a known history of infection with HIV, hepatitis B, or hepatitis C.

          -  Have a serious nonmalignant disease that, in the opinion of the Investigator and/or
             the Medical Monitor, could compromise protocol objectives.

          -  Are currently receiving any other investigational agent.

          -  Have exhibited allergic reactions to docetaxel, or a similar structural compound,
             biological agent, or formulation.