Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02739633
Other study ID # Genexol-PM PC
Secondary ID
Status Recruiting
Phase Phase 2
First received March 21, 2016
Last updated April 16, 2018
Start date April 2016
Est. completion date December 2019

Study information

Verified date April 2018
Source Samyang Biopharmaceuticals Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase II Study of Weekly Genexol®-PM Plus Gemcitabine in Subjects With Recurrent and Metastatic Adenocarcinoma of the Pancreas.


Description:

The aim of the this phase II study is to assess the efficacy and safety of a combination treatment of Genexol®-PM plus gemcitabine in patients with recurrent and metastatic adenocarcinoma of the pancreas.


Recruitment information / eligibility

Status Recruiting
Enrollment 47
Est. completion date December 2019
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

1. Patient has definitive histologically or cytologically confirmed recurrent and metastatic adenocarcinoma of the pancreas. The definitive diagnosis of recurrent and metastatic pancreatic adenocarcinoma will be made by integrating the histopathological data within the context of the clinical and radiographic data. Patients with islet cell neoplasms are excluded.

2. Initial diagnosis of recurrent and metastatic disease must have occurred =6 weeks prior to randomization in the study.

3. Patient has one or more lesions measurable by CT scan or MRI (if patient is allergic to CT contrast media).

4. Male or non-pregnant and non-lactating female, and = 20 years of age.

5. Patient must meet the following blood counts at Baseline (obtained =14 days prior to randomization):

- Absolute neutrophil count (ANC) = 1.5 × 10^9/L

- Platelet count = 100,000/mm3 (100 × 10^9/L)

- Hemoglobin (Hgb) = 9 g/dL.

6. Patient has the following blood chemistry levels at Baseline (obtained =14 days prior to randomization):

- AST (SGOT), ALT (SGPT) = 2.5 × upper limit of normal range (ULN), unless liver metastases are clearly present, then = 5 × ULN is allowed.

- Total bilirubin =ULN

7. Patient has a Karnofsky performance status (KPS) = 70. Two observers will be required to assess KPS. If discrepant, the one with the lowest assessment will be considered true.

8. Patient has voluntarily agreed to participate in the study, and signed the Informed Consent Form (ICF) prior to participation in any study-related activities.

Exclusion Criteria:

1. History of malignancy in the last 5 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible if they were cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.

2. Patients have uncontrolled bacterial, viral, or fungal infections

3. Patient has known historical or active infection with HIV, hepatitis B, or hepatitis C.

4. Patients have a history of allergy or hypersensitivity to any of Paclitaxel, Gemcitabine, or Cremophor EL.

5. Patients with high cardiovascular risk, including recent coronary stenting or myocardial infarction in the past 6 months.

6. History of Peripheral Artery Disease (e.g,. claudication, Leo Buerger's disease).

Study Design


Related Conditions & MeSH terms

  • Adenocarcinoma
  • Metastatic Adenocarcinoma of the Pancreas
  • Recurrent Adenocarcinoma of the Pancreas

Intervention

Drug:
Genexol-PM
125 mg/m2 given intravenously over 60 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
Gemcitabine
1000 mg/m2 given intravenously for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.

Locations

Country Name City State
Korea, Republic of Samyang Biopharmaceuticals Seoul

Sponsors (1)

Lead Sponsor Collaborator
Samyang Biopharmaceuticals Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective response rate (ORR) as assessed by RECIST. ORR will be summarized as the percentage of participants who achieved a confirmed complete (CR) or partial response (PR) using RECIST guidelines.
Response is confirmed at least 4 weeks later.
8 weeks
Secondary Progression free survival (PFS) Time from the date of enrollment until the date of objective disease progression or the date of death.
PFS will be summarized using Kaplan-Meier methods.
2 years
Secondary Overall survival (OS) OS will be summarized using Kaplan-Meier methods. 2 years
Secondary Disease control rate (DCR) DCR is defined as the percentage of patients who have achieved complete response, partial response and stable disease 8 weeks
Secondary Number of participants with adverse events A adverse event (AE) is as any AE occurring or worsening on or after the first treatment of any study drug, and within 21 days after the last dose of the last study drug.
Severity grades according to NCI CTCAE version 4.0.
Baseline up to Day 21 after the last dose of study treatment
See also
  Status Clinical Trial Phase
Recruiting NCT05557851 - Minnelide Along With Abraxane Plus Gemcitabine in Patients With Metastatic Adenocarcinoma of the Pancreas Phase 1
Not yet recruiting NCT06225999 - Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas Phase 2
Completed NCT00873353 - Trial to Evaluate the Efficacy and Safety of Tarceva and Capecitabine in Advanced Pancreatic Cancer Patients Phase 2
Terminated NCT01654861 - Safety & Efficacy Study of Gemcitabine...With High Dose IV Vit. C (HDIVC) Phase 1
Active, not recruiting NCT04083235 - A Study to Assess the Effectiveness and Safety of Irinotecan Liposome Injection, 5-fluorouracil/Leucovorin Plus Oxaliplatin in Patients Not Previously Treated for Metastatic Pancreatic Cancer, Compared to Nab-paclitaxel+Gemcitabine Treatment Phase 3
Completed NCT02184195 - Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy Phase 3