Back to results

Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer (PC6)

Primary Purpose

Pancreatic Cancer

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

G17DT

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects with a histologically or cytologically confirmed diagnosis of pancreatic carcinoma, who were not eligible for tumor resection with curative intent (i.e., Stage II, III, or IV disease)
Male or female subjects over 18 years of age
Subjects with a life expectancy of at least 2 months
KPS score of ≥60%
Written informed consent

Exclusion Criteria:

Previous, concomitant, or anticipated use (up to Week 12) of chemotherapy, radiotherapy, immunotherapy, or any other anticancer therapy
Previous (during the 4 weeks before the study), concomitant, or anticipated use (up to Week 12) of immunosuppressants. However, for systemic [i.e., oral or injected] corticosteroids, previous use and concomitant use at study entry were prohibited, while introduction during the course of the study was permitted.)
History of other malignant tumor within the previous 5 years, except nonmelanomatous skin cancer, and in situ carcinoma of the uterine cervix
Known immunodeficiency
Females who were pregnant, planning to become pregnant, or lactating (Women who, in the opinion of the investigator, were of childbearing potential were to have a negative pregnancy test before study drug administration.)
Subjects taking part in another study involving an investigational or licensed drug or device in the 3 months preceding enrollment or up to Week 12 during this study
Previous G17DT treatment
Hematological indicators as follows:
- Hemoglobin <9.5 g/dL
- Neutrophils <2.0 × 109/L
- Platelets <100 × 109/L
Any other condition or circumstance that might have the following results:
- Worsen if the subject participated in the study
- Reduce the subject's ability to comply with the protocol
- Confound the interpretation of the study results

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

G17DT

Placebo

Arm Description

250 µg administered at Weeks 0,1,3 and 24 by intramuscular injection, followed by additional injections (boosters) of 250 µg every 6 months at investigator's discretion.

Placebo administered at Weeks 0, 1, 3, and 24 by intramuscular injection followed by additonal injections of placebo every 6 months.

Outcomes

Primary Outcome Measures

Patient Survival

The vital status of each patient was followed until death or end of the study.

Number of Participants with Serious and Non-Serious Adverse Events

Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit.

Secondary Outcome Measures

Objective tumor response

Patients were monitored for an objective tumor response measured by means of an abdomincal computed tomography.

Full Information

NCT ID

NCT02118077

First Posted

April 16, 2014

Last Updated

April 17, 2014

Sponsor

Cancer Advances Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02118077

Brief Title

Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer

Acronym

PC6

Official Title

A Prospective, Randomized, Double-blind, Placebo-controlled, Group Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

April 2001 (undefined)

Primary Completion Date

April 2004 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cancer Advances Inc.

4. Oversight

5. Study Description

Brief Summary

Compare the effect of G17DT with that of placebo on the survival of subjects with advanced pancreatic cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

154 (Actual)

8. Arms, Groups, and Interventions

Arm Title

G17DT

Arm Type

Experimental

Arm Description

250 µg administered at Weeks 0,1,3 and 24 by intramuscular injection, followed by additional injections (boosters) of 250 µg every 6 months at investigator's discretion.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered at Weeks 0, 1, 3, and 24 by intramuscular injection followed by additonal injections of placebo every 6 months.

Intervention Type

Biological

Intervention Name(s)

G17DT

Primary Outcome Measure Information:

Title

Patient Survival

Description

The vital status of each patient was followed until death or end of the study.

Time Frame

Up to week 134

Title

Number of Participants with Serious and Non-Serious Adverse Events

Description

Adverse events, defined as any event involving adverse reactions, illnesses with onset during the study, or exacerbations of pre-exisiting illnesses, were assessed at each visit.

Time Frame

up to week 134

Secondary Outcome Measure Information:

Title

Objective tumor response

Description

Patients were monitored for an objective tumor response measured by means of an abdomincal computed tomography.

Time Frame

Weeks 24 and 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with a histologically or cytologically confirmed diagnosis of pancreatic carcinoma, who were not eligible for tumor resection with curative intent (i.e., Stage II, III, or IV disease) Male or female subjects over 18 years of age Subjects with a life expectancy of at least 2 months KPS score of ≥60% Written informed consent Exclusion Criteria: Previous, concomitant, or anticipated use (up to Week 12) of chemotherapy, radiotherapy, immunotherapy, or any other anticancer therapy Previous (during the 4 weeks before the study), concomitant, or anticipated use (up to Week 12) of immunosuppressants. However, for systemic [i.e., oral or injected] corticosteroids, previous use and concomitant use at study entry were prohibited, while introduction during the course of the study was permitted.) History of other malignant tumor within the previous 5 years, except nonmelanomatous skin cancer, and in situ carcinoma of the uterine cervix Known immunodeficiency Females who were pregnant, planning to become pregnant, or lactating (Women who, in the opinion of the investigator, were of childbearing potential were to have a negative pregnancy test before study drug administration.) Subjects taking part in another study involving an investigational or licensed drug or device in the 3 months preceding enrollment or up to Week 12 during this study Previous G17DT treatment Hematological indicators as follows: Hemoglobin <9.5 g/dL Neutrophils <2.0 × 109/L Platelets <100 × 109/L Any other condition or circumstance that might have the following results: Worsen if the subject participated in the study Reduce the subject's ability to comply with the protocol Confound the interpretation of the study results

12. IPD Sharing Statement

Learn more about this trial

Sequential Trial of G17DT for the Treatment of Advanced Pancreatic Cancer

We'll reach out to this number within 24 hrs