An Open-Label Phase I/II Clinical Study of PT-112 in Combination With Docetaxel in Subjects With Advanced Solid Tumor in a Phase I Dose Escalation Study and in Subjects With Non-Small Cell Lung Cancer (NSCLC) in a Phase II Dose Confirmation Study

NCT02884479 | Unknown Phase 1 DMC

• 1 other identifier: SCI-PT112-ONC-P1-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to test PT-112 in Combination with Docetaxel in Subjects with Advanced Solid Tumor in a Phase I Dose Escalation Study and in Subjects with Non-Small Cell Lung Cancer.

Conditions

Advanced Solid Tumor; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• dose-limiting toxicities (DLTs)

  Day 0 to Day 28

• area under the plasma concentration-time curve from 0 to the last measurable concentration (AUClast)

  Cycle 1, Day 1: Pre-dose, 0.5, 1, 1.25, 1.5, 2, 3, 5, 8, 12, 24 hours post dose Cycle 1, Day 8: Pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24 hours post dose Cycle 2, Day 8: Pre-dose, 1, 2, 4 hours post dose Cycle 3 & 4, Day 8: Pre-dose

Secondary Outcomes (1)

• Adverse Events

  Cycle 1: Day 1, Day 8, Day 15; Cycle 2: Day 1, Day 8; Follow up: 30 days post final dose

Study Arms (1)

PT-112 + Docetaxel

EXPERIMENTAL

Increasing doses of intravenously administered PT-112 in combination with 60 mg/m2 docetaxel every 3 weeks (Q3W) in subjects with advanced solid tumor of any histological type.

Drug: PT-112; Drug: Docetaxel

Interventions

PT-112 DRUG

Increasing doses of intravenously administered PT-112 in combination with 60 mg/m2 docetaxel every 3 weeks (Q3W) in subjects with advanced solid tumor of any histological type.

PT-112 + Docetaxel

Docetaxel DRUG

Increasing doses of intravenously administered PT-112 in combination with 60 mg/m2 docetaxel every 3 weeks (Q3W) in subjects with advanced solid tumor of any histological type.

PT-112 + Docetaxel

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 20 years of age on the day of signing informed consent.
• Subjects with advanced tumor of any histological type and meet the following eligibility criteria for the corresponding part of the study:
• In Part 1, the subjects who failed at least one prior therapy must have pathologically confirmed advanced solid tumor of any histological type with preference of subjects with advanced NSCLC and either no available, or intolerable to, standard of-care treatment.
• In Part 2, the subjects must have pathologically confirmed advanced NSCLC. Subjects are required to have evidence of measurable disease per RECIST v1.1.
• Eastern Collaborative Oncology Group (ECOG) Performance Status ≤ 1.
• Subject must have adequate organ function as indicated by the following laboratory values:
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L.
• Platelets ≥ 100 × 109/L.
• Hemoglobin ≥ 90 g/L or 5.6 mmol/L.
• Serum creatinine ≤ 1.5 × upper limit of normal (ULN), or calculated or directly measured creatinine clearance ≥ 60% lower limit of normal (LLN).
• Serum total bilirubin ≤ 1.5 × ULN (subjects with Gilbert's Syndrome are allowed if direct bilirubin is within normal limits).
• Aspartate aminotransferase (AST \[SGOT\]) and/or alanine aminotransferase (ALT \[SGPT\]) ≤ 2.5 × ULN, or ≤ 5 × ULN in presence of liver metastases.
• International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.
• Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
• Albumin ≥ 3 mg/dL.

You may not qualify if:

• Subjects meeting any of the following criteria are ineligible for participation in the study:
• Any cytotoxic chemotherapy within 21 days, prior to initiation of study drug.
• Receipt of more than three prior regimens of cytotoxic chemotherapy (immunotherapy and targeted therapy will not be counted as a line of therapy).
• History of hypersensitivity reaction to docetaxel and polysorbate 80 or any of its components.
• Presence of an acute or chronic toxicity of prior chemotherapy, with the exception of alopecia, that has not resolved to Grade 1, as determined by National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03.
• Evidence of peripheral neuropathy of Grade 2 or greater within 28 days prior to initiation of dosing.
• Symptomatic brain metastasis requiring active treatment.
• Bone marrow reserve which, in the clinical judgment of the Principal Investigator, is not adequate for participation in this study.
• Known allergy or hypersensitivity to Pt-containing agents, or known intolerance to a prior Pt-containing agent which, in the judgment of the Principal Investigator, precludes re-exposure to a Pt-containing agent.
• Radiotherapy within 28 days prior to baseline and/or receipt of radiotherapy to \>25 % of bone marrow volume.
• Major surgery within 28 days prior to initiation of study drug combination.
• Life expectancy \<12 weeks.
• Active or clinically unstable bacterial, viral, or fungal infection requiring systemic therapy.
• Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness.
• Clinically significant hearing impairment, as judged by the Principal Investigator.

Sponsors & Collaborators

• SciClone Pharmaceuticals International (Cayman) Development Limited: lead
• Parexel: collaborator
• National Cheng-Kung University Hospital: collaborator

Study Sites (4)

Changhua Christian Hospital

Changhua County, Taiwan

RECRUITING

China Medical University & Hospital

Taichung, Taiwan

NOT YET RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

RECRUITING

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Wu-Chou Su

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Qin, M.D, Ph.D

CONTACT

86-21-2319 3802; cqin@sciclone.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 31, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: April 25, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

TW (4)