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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Santa Monica, California, 90404 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Advanced Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 (unless related to
underlying malignancy or prior related treatment) or history of abdominal fistula,
gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within
6 months prior to study enrollment.

NCT00932126
Pfizer
Terminated
This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors

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This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors
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
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.
The study was prematurely terminated on 26Jul2011 due to the undesirable PK characteristics of PF-03758309 and the lack of an observed dose-response relationship. There were no safety concerns that contributed to the study termination.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Tumors
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.
Experimental: 1
Intervention: Drug: PF-03758309
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
December 2011
December 2011   (Final data collection date for primary outcome measure)

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 (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   United States
 
 
NCT00932126
B1301001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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