Phase 2 Study of EC145 Alone Versus EC145+Docetaxel Versus Docetaxel Alone in Participants With FR(++) 2nd Line Non Small Cell Lung Cancer

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will test the activity of single-agent EC145 and the combination of EC145 plus docetaxel against the current standard docetaxel in second line Non Small Cell Lung Cancer (NSCLC) (adenocarcinoma, squamous, adenosquamous or adenocarcinoma with other NSCLC variants of the lung) in participants with all target lesions expressing the folate receptor [FR(++)].

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endocyte
• Treatments: Docetaxel; Folic Acid; Vinca Alkaloids

Criteria

Inclusion Criteria:

1. Ability to sign an approved informed consent form (ICF).

2. Must be ≥ 18 years of age.

3. Histology confirmed diagnosis of non-small cell lung cancer (adenocarcinoma, squamous, adenosquamous, or adenocarcinoma with other NSCLC variants of the lung) (Stage IIIB or IV).

4. All (RECIST v1.1-defined) target lesions positive for the folate receptor [FR(++)] by SPECT scan.

5. Only one prior systemic therapy for advanced disease (e.g.,a platinum doublet or a maintenance regimen that includes a platinum doublet; in addition, the participant may have received an epidermal growth factor receptor [EGFR] inhibitor).

6. Radiological evaluation conducted no more than 28 days prior to beginning study therapy. If history of CNS metastasis baseline radiological imaging must include brain MRI or CT.

7. Radiologic evidence of disease progression following the most recent prior treatment.

8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

9. Must have recovered (to baseline/stabilization) from prior cytotoxic-therapy-associated acute toxicities.

10. Prior radiation therapy is allowed if the following criteria is met:

• Radiation to < 25% of the bone marrow; whole pelvis radiation is excluded.

• Prior radiotherapy must be completed at least 2 weeks before randomization.

• Must have recovered from the acute toxic effects of the treatment before randomized.

• Prior thoracic radiation must be completed 30 days before study enrollment.

• Irradiated pulmonary lesions cannot be used as target or non-target lesions (and must be excluded) unless there is previous documented progression of these lesions.

• Palliative extrathoracic radiotherapy can continue, but these lesions must be excluded as target and non-target lesions.

11. Adequate organ function:

• Bone marrow reserve: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. Platelets ≥ 100 x 109/L. Hemoglobin ≥ 9 g/dL.

• Hepatic: Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). Alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT), and lactate dehydrogenase (LDH) and alkaline phosphatase ≤ 2.5 x ULN.

• Renal: Serum creatinine ≤ 1.5 x ULN, or for participants with serum creatinine > 1.5 ULN, creatinine clearance ≥ 50 mL/min/1.73 m2 (50mL/min/1.73m2 is equivalent to 0.83 mL/s/m2).

12. Participants of childbearing potential:

• Women who are capable of becoming pregnant must have a negative serum pregnancy test within 1 week prior to exposure to EC20 and within 1 week prior to exposure to treatment with EC145 and/or docetaxel.

• Women who are capable of becoming pregnant and male participants who are sexually active must practice an effective method of birth control for the duration of their participation in the trial through 3 months following the last dose of EC145 and through 6 months following the last dose of docetaxel.

Exclusion Criteria:

1. Prior therapy with docetaxel, vinorelbine, or vinca-containing compounds.

2. Known hypersensitivity to docetaxel or polysorbate 80.

3. Symptomatic central nervous system (CNS) metastases or metastases that result in midline shift, significant edema.

4. Malignancies other than NSCLC that are expected to alter life expectancy or may interfere with disease assessment. Patients with adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or low-grade (Gleason score ≤ 6) localized prostate cancer and patients with prior history of malignancy who have been disease free for more than 3 years are eligible.

5. Serious cardiac illness or medical conditions such as unstable angina, pulmonary embolism, or uncontrolled hypertension.

6. Anti-folate therapy such as methotrexate for rheumatoid arthritis.

7. Baseline peripheral neuropathy CTCAE ≥ Grade 2.

8. Pregnant or lactating women.

9. Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy.

10. Active infections (e.g., hepatitis or HIV carriers)