Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer

NCT04131192 | Terminated Phase 1

• 1 other identifier: PCD-DZ650-19-001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of dose limiting toxicities of each subject

  Rate will be assessed through summaries of adverse events, clinical laboratory abnormalities, and changes in physical exam and vital signs. All subjects who receive a single dose of study medication will be considered evaluable for safety.

  21 days

Secondary Outcomes (6)

• Adverse events related to pulse dose Z650 and gemcitabine

  up to 4 weeks after last dose

• Overall response rate (ORR)

  up to approximately 24 months

• Disease Control Rate (DCR)

  up to approximately 24 months

• Duration of Response (DOR)

  up to approximately 24 months

• Progression-free Survival (PFS)

  up to approximately 24 months

Study Arms (1)

z650 and Gemcitabine

EXPERIMENTAL

Z650:250 or 300 or 200 mg/d, starting on the 2nd day, once a day, continuous administration, or about half an hour after a meal Gemcitabine: intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle FOR the 4-6 cycles

Drug: Z650; Drug: Gemcitabine

Interventions

Z650 DRUG

250 or 300 or 200 mg/d, starting on the 2nd day, once a day, continuous administration, or about half an hour after a meal

Also known as: larotinib

z650 and Gemcitabine

Gemcitabine DRUG

Gemcitabine will be administered intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle ，for 4-6 cycles

Also known as: Gemzar

z650 and Gemcitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ age ≤ 75 years old, male or female is not limited; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Life expectancy of ≥ 12 weeks Pathologically confirmed advanced pancreatic cancer defined as non-operable in a curative intent, locally recurrent, or metastatic disease.

You may not qualify if:

• adjuvant treatment with gemcitabine within 6 months prior to the first dose; Radiotherapy and anti-cancer Chinese patent medicine treatment were performed within 4 weeks before the first dose; Gastrointestinal diseases that could affect the absorption of Z650, (e.g., serious swallowing obstruction, chronic diarrhea, bowel obstruction); Doppler ultrasound evaluation of Left ventricular ejection fraction \< 50%

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (2)

Jiangsu Province Hospital

Nanjing, China/jiangsu, 210029, China

Location

shandong Cancer Hospital

Jinan, China/shandong, 250117, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• shu zhang

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

• lianke liu

  The First Affiliated Hospital with Nanjing Medical 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: October 10, 2019
• First Posted: October 18, 2019
• Study Start: November 11, 2019
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: May 6, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)