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: 19.0 Level: PT Classification code 10005003 Term: Bladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 19.0 Level: PT Classification code 10017614 Term: Gallbladder cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-07
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Provide signed written informed consent prior to the initiation of any
study-specific procedures.
2. (Part 2 only) Cohort 1: Have histologically or cytologically confirmed
diagnosis of Stage IV squamous NSCLC and have not received prior
chemotherapy for metastatic disease. 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.
- 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:

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. Are pregnant or breast-feeding.
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