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Hedgehog Inhibition for Pancreatic Ductal Adenocarcinoma (PDAC) in the Preoperative Setting (HIPPoS) (HIPPoS)

Primary Purpose

Pancreatic Ductal Adenocarcinoma

Status

Terminated

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

GDC-0449

About this trial

This is an interventional treatment trial for Pancreatic Ductal Adenocarcinoma focused on measuring Pancreatic, adenocarcinoma, cancer

Eligibility Criteria

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

Inclusion Criteria:

Documented tissue diagnosis of pancreatic ductal adenocarcinoma with a sufficient amount of tissue for Laser Capture Micro-dissection (LCM) of the stromal and tumour compartments.
Confirmed eligibility for a Whipple's or distal pancreatectomy procedure by Multi-Disciplinary Team (MDT) and surgeon review.
Adequate organ function defined as:
- Creatinine clearance ≥ 50ml/min (as defined by Cockcroft-Gault)
- Electrolytes (Sodium (Na)/Potassium (K)/Calcium (Ca)) within institutional normal limits
- Alanine transaminase (ALT)/Aspartate transaminase (AST) <5*ULN
- Partial thromboplastin time (PTT)<2*ULN, prior supplementation with vitamin K is allowed
- Adequate blood counts: neutrophils >1,500/μl, Hb > 6mmol/L,platelets >100.000/μl
- Albumin ≥ 25mg/dL
Written informed consent
Male or female aged 18 years or over.
World Health Organization (WHO) performance status 0-1
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Males should not donate sperm during treatment or up to 3 months after the last dose.
Women of childbearing potential are required to have a negative serum pregnancy test (with sensitivity of at least 25 mIU/mL) within 10-14 days and within 24 hours prior to the first dose of GDC-0449.

Exclusion Criteria:

Known Hepatitis B/C or Human Immunodeficiency Virus (HIV) infection
Known hypersensitivity to GDC-0449
Active cardiac ischemic disease (this criterion only applies for participation in the imaging part of the study)
Women, who are pregnant plan to become pregnant or are lactating (during the study or for up to 12 months after the last dose).
Concurrent participation in another clinical trial using an investigational medicinal product.
Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or in the judgment of the investigator would make it undesirable for the patient to enter the trial (i.e. patients is not able to swallow tablets).

Sites / Locations

Cambridge University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GDC-0449

Arm Description

Study drug.

Outcomes

Primary Outcome Measures

To study the effect of GDC-0449 treatment on the stromal cell and tumour cell hedgehog signalling in patients with Pancreatic Ductal Adenocarcinoma.

To study the effect of GDC-0449 treatment on the stromal cell and tumour cell hedgehog signalling in patients with Pancreatic Ductal Adenocarcinoma. To study the safety and tolerability of pre-operative GDC-0449 treatment in patients who undergo Whipple's or distal pancreatectomy surgery for Pancreatic Ductal Adenocarcinoma.

Secondary Outcome Measures

Full Information

NCT ID

NCT01096732

First Posted

March 30, 2010

Last Updated

January 7, 2014

Sponsor

Lisa Bax

Collaborators

Roche Pharma AG, Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01096732

Brief Title

Hedgehog Inhibition for Pancreatic Ductal Adenocarcinoma (PDAC) in the Preoperative Setting (HIPPoS)

Acronym

HIPPoS

Official Title

Proof of Mechanism Study of an Oral Hedgehog Inhibitor (GDC-0449) in Patients With Resectable Pancreatic Ductal Adenocarcinoma in the Pre-operative Window Period

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Terminated

Why Stopped

Slow recruitment

Study Start Date

February 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lisa Bax

Collaborators

Roche Pharma AG, Genentech, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This clinical trial is looking at the effect of a new drug called GDC-0449 in patients with cancer of the pancreas. Laboratory studies have shown that this drug blocks a process in pancreatic cells thought to be involved in cancer development and spread. This process is called the 'Hedgehog signalling pathway'. As yet, it is unclear whether blocking hedgehog signalling will directly affect the tumour cells themselves or the surrounding normal tissue. Understanding this distinction will help improve treatment strategies for pancreatic cancer. Patients will be offered to participate in this research study if they have localised pancreatic cancer that can be removed by surgery. In the period between diagnosis and surgery the investigators do not normally treat patients, however in this trial the investigators will ask patients to take GDC-0449 during the approximately two weeks until the day of surgery. All patients that enter this study will have undergone a diagnostic biopsy of the pancreatic tumour and the investigators will collect a second sample of the tumour at surgery. The main question of this study is whether the investigators can detect a change in hedgehog signalling in the normal tumour surrounding tissue. Furthermore the investigators will look very carefully whether this treatment is safe for patients. All problems before and after surgery will be carefully documented and the investigators have defined strict rules to stop the study if the investigators observe serious problems.

Detailed Description

Please contact Principal Investigators team for full details.

6. Conditions and Keywords

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

Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic, adenocarcinoma, cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GDC-0449

Arm Type

Experimental

Arm Description

Study drug.

Intervention Type

Drug

Intervention Name(s)

GDC-0449

Other Intervention Name(s)

VISMODEGIB

Intervention Description

Gelatine capsules of 150mg.Taken O.D. for 14 days.

Primary Outcome Measure Information:

Title

To study the effect of GDC-0449 treatment on the stromal cell and tumour cell hedgehog signalling in patients with Pancreatic Ductal Adenocarcinoma.

Description

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Documented tissue diagnosis of pancreatic ductal adenocarcinoma with a sufficient amount of tissue for Laser Capture Micro-dissection (LCM) of the stromal and tumour compartments. Confirmed eligibility for a Whipple's or distal pancreatectomy procedure by Multi-Disciplinary Team (MDT) and surgeon review. Adequate organ function defined as: Creatinine clearance ≥ 50ml/min (as defined by Cockcroft-Gault) Electrolytes (Sodium (Na)/Potassium (K)/Calcium (Ca)) within institutional normal limits Alanine transaminase (ALT)/Aspartate transaminase (AST) <5*ULN Partial thromboplastin time (PTT)<2*ULN, prior supplementation with vitamin K is allowed Adequate blood counts: neutrophils >1,500/μl, Hb > 6mmol/L,platelets >100.000/μl Albumin ≥ 25mg/dL Written informed consent Male or female aged 18 years or over. World Health Organization (WHO) performance status 0-1 Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Males should not donate sperm during treatment or up to 3 months after the last dose. Women of childbearing potential are required to have a negative serum pregnancy test (with sensitivity of at least 25 mIU/mL) within 10-14 days and within 24 hours prior to the first dose of GDC-0449. Exclusion Criteria: Known Hepatitis B/C or Human Immunodeficiency Virus (HIV) infection Known hypersensitivity to GDC-0449 Active cardiac ischemic disease (this criterion only applies for participation in the imaging part of the study) Women, who are pregnant plan to become pregnant or are lactating (during the study or for up to 12 months after the last dose). Concurrent participation in another clinical trial using an investigational medicinal product. Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or in the judgment of the investigator would make it undesirable for the patient to enter the trial (i.e. patients is not able to swallow tablets).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Tuveson, MD PhD

Organizational Affiliation

Cancer Research UK

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cambridge University Hospitals NHS Foundation Trust

City

Cambridge

ZIP/Postal Code

CB2 0QQ

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Hedgehog Inhibition for Pancreatic Ductal Adenocarcinoma (PDAC) in the Preoperative Setting (HIPPoS)

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