This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00932126

Purpose

This is the first study using PF-03758309, an oral compound, in patients with advanced solid tumors. In this study different doses of PF-03758309 will be administered to different groups of patients. The study will assess the compound's safety, the blood levels of PF-03758309 during the treatment and the effect of the compound on the tumor cells.

Condition	Intervention	Phase
Advanced Solid Tumors Sarcomas Carcinomas	Drug: PF-03758309	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	Phase 1, Open Label, Dose-Escalation, Safety, Pharmacokinetic And Pharmacodynamic Study Of Single Agent PF-03758309, An Oral PAK4 Inhibitor, In Patients With Advanced Solid Tumors

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Maximum tolerated dose for two different schedules consecutively explored: continuous and intermittent. [ Time Frame: 10 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the safety profile of PF-03758309 [ Time Frame: 22 Months ] [ Designated as safety issue: Yes ]
Pharmacokinetic study [ Time Frame: 22 Months ] [ Designated as safety issue: No ]
Pharmacodynamic study [ Time Frame: 22 Months ] [ Designated as safety issue: No ]
Effect of PF-03758309 on functional imaging with FLT-PET (Positron Emission Tomography) [ Time Frame: 22 Months ] [ Designated as safety issue: No ]
Antitumor activity of PF-03758309 [ Time Frame: 22 Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	August 2009
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: PF-03758309 Oral PF-03758309 will be administered in capsules (once or twice daily) until toxicity, progressive disease, or patient refusal to continue on therapy. The starting dose is 1 mg once daily.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available.
ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) must be 0 or 1.
Adequate bone marrow, liver and kidney function.

Exclusion Criteria:

Patients with known brain metastases.
Previous high dose chemotherapy requiring stem cell rescue.
Prior irradiation to >25% of the bone marrow.
Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV).
Current active treatment in another clinical study.
Pregnancy or breast feeding.
Active inflammatory gastrointestinal disease, chronic diarrhea or previous gastric resection. History of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932126

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1301001
Study First Received:	June 30, 2009
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00932126 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Phase 1 dose escalation dose finding pharmacokinetic and pharmacodynamic study

Study placed in the following topic categories:

Disulfiram
Signs and Symptoms
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor

Sarcoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on September 10, 2009