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

Phase 1

Active, not recruiting

• Conditions: Advanced solid tumors and first-line metastatic squamous NSCLC; firstline 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: 21.1Level: 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 10005003Term: Bladder 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-IT
• Lead Sponsor: ANOCARRIER CO, LIMITED

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-05
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Not 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.
- 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.
- Patients whose tumors are known to harbor an ALK translocation must have had intolerance or have progressed on at least 1 and up to 2 ALK inhibitors.
(Part 2 only) 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. (Part 2 only) 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.
Mixed
undifferentiated histology requires immunohistochemistry consistent with a TCC origin. Predominantly squamous or
neuroendocrine tumors
are excluded.
3. Have measurable disease per RECIST version 1.1.
4. Are males or females aged =18 years.
5. Have an ECOG performance status of 0 to 1.
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 postmen

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
XML File Identifier: tPlPZ5rSiOxuu1wqhkLYhtuhz2U=
Page 17/27 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. 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.
11. 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.
12. 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