You are here

Our science / Clinical Trials / Find a Trial / NCT00932126

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

Back to Search Print Save as PDF Bookmark Trial

NCT00932126

Last updated on August 9, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Santa Monica, California, 90404 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Advanced Solid Tumors
An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)
NCT02997176
All Genders
18+
Years
Multiple Sites
Part 1, MELANOMA, SCCHN, OVCA, SARCOMA, OTHER SOLID TUMORS, Part 1 and 2, NSCLC, UROTHELIAL CARCINOMA
A Dose Escalation Study Of PF-06801591 In Melanoma, Head And Neck Cancer (SCCHN), Ovarian, Sarcoma, Non-Small Cell Lung Cancer, Urothelial Carcinoma or Other Solid Tumors
NCT02573259
All Genders
18+
Years
Multiple Sites
Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors
NCT03330405
All Genders
18+
Years
Multiple Sites
Androgen Receptor Positive Triple Negative Breast Cancer Advanced
Safety and Efficacy Study of Enzalutamide in Patients With Advanced, Androgen Receptor-Positive, Triple Negative Breast Cancer
NCT01889238
Females
18+
Years
Multiple Sites
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now