Phase I Study of SPH1188-11 in NSCLC

NCT03231475 | Withdrawn Phase 1

• 1 other identifier: SPH1188-11-101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will treat patients with advanced NSCLC who have already received at least one course of specific anti-cancer treatment but the tumour has started to re-grow following that treatment. This is the first time this drug has ever been tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment, it will measure the levels of drug in the body, it will also measure the anti-cancer activity. By using these pieces of information together the best dose of this drug to use in further clinical trials will be selected.

Conditions

NSCLC Stage IIIB; NSCLC Stage IV

Keywords

NSCLC; EGFR-TKI

Outcome Measures

Primary Outcomes (1)

• DLT and MTD of SPH1188-11

  Incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with increasing doses of SPH1188-11, to find DLT and MTD

  28 days

Secondary Outcomes (7)

• Tmax of SPH1188-11

  28 days

• ORR of SPH1188-11

  52 weeks

• PFS of SPH1188-11

  52 weeks

• DCR of SPH1188-11

  52 weeks

• Cmax of SPH1188-11

  28 days

Study Arms (1)

SPH1188-11

EXPERIMENTAL

SPH1188-11 dose escalation, 50mg/100mg/200mg/300mg/450mg/600mg

Drug: SPH1188-11

Interventions

SPH1188-11 DRUG

qd.po

Also known as: SPH1188

SPH1188-11

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, male or female.
• Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer(NSCLC),Stage IIIBorIV, previous treatment with 1st EGFR-TKI, and/or previous chemotherapy. Regardless of EGFR mutation status.
• At least one measurable disease according to RECIST 1.1.
• Life expectancy of at least 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
• Females should be using adequate contraceptive measures from the time of screening until 3 months after discontinuing study treatment, should not be breast feeding and must have a negative pregnancy test 7days prior to start of dosing. Males should be willing to use barrier contraception during the trial and 3 months after discontinuing study treatment.
• Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.

You may not qualify if:

• Treatment with an EGFR-TKI(eg, erlotinib, gefitinib, icotinib) within 7 days or approximately 5x half-life of study entry.
• Previous treatment with 2nd EGFR-TKI or 3rd EGFR-TKI(eg, afatinib, osimertinib).
• Any cytotoxic chemotherapy or anticancer drugs within 4 weeks of the first dose of study treatment.
• Major surgery(excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
• Radiotherapy within 4 weeks of the first dose of study treatment.
• Patients currently receiving(or unable to stop use at least 1 week prior to receiving the first dose) medications or herbal supplements known to be potent inhibitors of CYP3A4/CYP2D6, and/or potent inducers of CYP3A4/CYP2D6.
• Laboratory values within 7 days of the first dose of study treatment:
• Absolute neutrophil count\<1.5×10\^9/L
• Platelet count \<100×10\^9/L
• Haemoglobin\<90 g/L
• Alanine aminotransferase\>2.5 times the upper limit of normal(ULN) if no demonstrable liver metastases or \>5 times ULN in the presence of liver metastases.
• Aspartate aminotransferase\>2.5 times ULN if no demonstrable liver metastases or \>5 times ULN in the presence of liver metastases.
• Total bilirubin\>1.5 times ULN if no liver metastases or \>3 times ULN in the presence of documented Gilbert's Syndrome(unconjugated hyperbilirubinaemia) or liver metastases.
• Creatinine\>1.5 times ULN concurrent with creatinine clearance \<50ml/min(measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is\>1.5 times ULN.
• Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events(CTCAE) grade 1 at the time of starting study treatment (except alopecia and prior platinum-therapy related neuropathy)

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• JunNing Cao, Master

  Fudan University

  PRINCIPAL INVESTIGATOR

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: June 6, 2017
• First Posted: July 27, 2017
• Study Start: July 21, 2017
• Primary Completion: December 31, 2020
• Study Completion: March 31, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)