Medical Treatment of Advanced Solid Tumors or Squamous Non-Small Cell Lung, Biliary Tract, and Bladder Cancer

Phase 1

• Conditions: Advanced solid tumors and first-line metastatic squamous NSCLC; first-line metastatic or locally advanced cholangiocarcinoma, gallbladder cancer, or ampullary cancer (biliary tract cancer); and first-line metastatic or locally advanced transitional cell carcinoma (TCC) of the urinary tract (bladder cancer).; MedDRA version: 20.0Level: PTClassification code 10005003Term: Bladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10017614Term: Gallbladder cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000084-16-BG
• Lead Sponsor: anoCarrier Co, Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-25
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Provide signed written informed consent prior to the initiation of any study-specific procedures.
2. Cohort 1: Have histologically or cytologically confirmed diagnosis of Stage IV squamous NSCLC and have not received prior chemotherapy or
immunotherapy for metastatic disease and are not known to be PD-L1 positive. Patients with known sensitizing mutation in the epidermal
growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) fusion oncogene must have received at least 1 and up to 2 targeted therapies prior to enrollment.
- A patient with stable, treated brain metastases is eligible, provided that there is no evidence of progression after treatment and the patient
does not require corticosteroids, or, if the patient requires corticosteroid, has been receiving a stable dose of corticosteroids for at least 14 days prior to assignment to treatment.
- Patients whose tumors are known to harbor an exon 19 deletion or exon 21 L858R EGFR mutation must have had intolerance or have progressed on at least 1 and up to 2 EGFR tyrosine kinase inhibitors. Cohort 2: Have histologically or cytologically confirmed diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma) and have not received prior systemic anticancer therapy for advanced or metastatic disease. Cohort 3: Have histologically or cytologically confirmed diagnosis of
metastatic or locally advanced TCC of the urinary tract (bladder, urethra, ureter, renal pelvis) (T3b-T4 N0 M0, Tany N1-N3 M0, or Tany Nany M1)
and are not candidates for surgery.
- Patients must not have received prior treatment with systemic anticancer therapy for metastatic or locally advanced urinary tract cancer.
- Certain mixed histologies that are predominantly (>50%) TCC are eligible: squamous, adenocarcinoma, and undifferentiated.
3. Have measurable disease per RECIST version 1.1.
4. Are males or females aged =18 years.
5. Have an ECOG PS of 0 to 1, with the exception of patients in Part 2 (Cohort 3, unfit bladder cancer patients) who may have an ECOG PS of 2.
6. Have adequate bone marrow reserve defined as:
- Absolute neutrophil count of at least 1.5 × 109/L,
- Platelet count of at least 100 × 109/L, and
- Hemoglobin level of 10 g/dL (transfusion is allowed to achieve hemoglobin level of at least 10 g/dL).
7. Have adequate liver function defined as:
- Total serum bilirubin <1.5 × upper limit of normal (ULN) and
- Baseline alanine transaminase, and aspartate transaminase <2.0 × ULN or, in patients with documented hepatic metastasis =5.0 × ULN and
Serum albumin =3.5 g/dL.
8. Prothrombin time within normal limits
9. Have a negative pregnancy test result at screening (for females of childbearing potential; not applicable to patients who are unable to become pregnant, including those with bilateral oophorectomy and/or hysterectomy or postmenopausal [no menses for the previous 12 months]).
10. Male patients must agree to use a condom during treatment and for 90 days after dosing.
11. For women of childbearing potential*: are willing to follow 1 of the following effective methods of birth control from the time of study entry to 6 months after the last day of treatment:
• Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
• Progestogen-only hormonal contraception associated

Exclusion Criteria

1. Have received prior platinum therapy in the past 3 months (Part 1) or 6 months in the adjuvant or neoadjuvant setting (Part 2).
2. Have received prior cisplatin and gemcitabine concomitantly within the last 6 months or are refractory to cisplatin and gemcitabine.
3. Are unable to receive platinum-based therapy due to previous toxicity.
4. Have unresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment, with the exception of alopecia and =Grade 1 peripheral neuropathy according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 (National Cancer Institute 2010). Clinical judgment by the investigator is allowed to determine if Grade 1 fatigue at
screening is residual toxicity from prior treatment or is a symptom of the patient’s general condition or disease. The investigator and Medical Monitor will discuss the eligibility of patients with baseline toxicity.
5. Have evidence suggesting pulmonary fibrosis or interstitial pneumonia.
6. Have a history of thrombocytopenia with complications including hemorrhage or bleeding of =Grade 2 according to the NCI CTCAE version 4.03 that required medical intervention or have any hemolytic condition or coagulation disorders that would make participation unsafe in the opinion of the investigator.
7. Have known hypersensitivity to platinum compounds or gemcitabine.
8. Have uncontrolled diabetes or have hypertension requiring more than 3 medications for control of hypertension.
9. Have known active hepatitis B (defined as a known positive hepatitis B surface antigen [HBsAg] result) or hepatitis C (defined by a known positive hepatitis C antibody result or known quantitative HCV RNA results greater than the lower limits of detection of the assay).
10. Are pregnant or breast-feeding.
11. Have signs or symptoms of organ failure, major chronic illnesses other than cancer, or any concomitant medical or social conditions that, in the opinion of the investigator, make it undesirable for the patient to participate in the study or that could jeopardize compliance with the protocol.
12. Have pre-existing alcoholic liver injury or significant liver disease.
13. Are regularly consuming alcohol within 6 months of Screening defined as an average weekly intake of >21 units (or an average daily intake of >3 units) for males or >14 units (or an average daily intake >2 units) for females. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine, or 1 measure (25 mL) of spirits.
14. Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia requiring medical therapy.
15. Are unwilling or unable to comply with study procedures or are planning to take a vacation for 7 or more consecutive days during the treatment phase of the study without prior consent from the Medical Monitor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified