Clinical Trials Logo
  1. Home
  2. Neoplasms
  3. NCT00225121
  4. Details
NCT00225121 Clinical Trial

Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors

Neoplasms Clinical Trial

Official title:
A PHASE 1, OPEN-LABEL, DOSE-ESCALATION STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF 2 DOSING SCHEDULES OF PF-00299804 IN PATIENTS WITH ADVANCED MALIGNANT SOLID TUMORS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00225121
Other study ID # A7471001
Secondary ID 2005-001140-23
Status Completed
Phase Phase 1
First received
Last updated
Start date October 11, 2005
Est. completion date September 23, 2010

Study information
Verified date December 2018
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to study the side effects of PF-00299804 and determine the highest dose that can be safely administered in patients with advanced cancer.

Other known NCT identifiers
  • NCT00276653
  • NCT00278291

Recruitment information / eligibility
Status Completed
Enrollment 121
Est. completion date September 23, 2010
Est. primary completion date April 3, 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Malignant solid tumor for which there is no currently approved treatment

- Adequate bone marrow, liver, cardiac, and kidney function

Exclusion Criteria:

- Cardiac disease

- Anticancer therapy within 4-6 weeks (depending on therapy)

- Pregnant or breast-feeding

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PF-00299804
investigational drug by oral route (escalating doses depending on safety) administered until progression

Locations
Country Name City State
Netherlands Vereniging het Nederlandse Kanker Instituut Amsterdam
United States University of Colorado Hospital Aurora Colorado
United States Dana Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States Ronald Reagan UCLA Medical Center Los Angeles California
United States UCLA Hematology/Oncology Los Angeles California
United States UCLA Oncology Center Los Angeles California
United States UCLA Hematology Oncology - Santa Monica Santa Monica California
United States UCLA Santa Monica Hematology/Oncology Santa Monica California

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety 6 months
Secondary Pharmacokinetics 6 months
Secondary Pharmacodynamics 6 months
Secondary Efficacy 6 months
See also
  Status Clinical Trial Phase
Completed NCT03826043 - THrombo-Embolic Event in Onco-hematology N/A
Terminated NCT03166631 - A Trial to Find the Safe Dose for BI 891065 Alone and in Combination With BI 754091 in Patients With Incurable Tumours or Tumours That Have Spread Phase 1
Completed NCT01938846 - BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors Phase 1
Recruiting NCT06058312 - Individual Food Preferences for the Mediterranean Diet in Cancer Patients N/A
Completed NCT03308942 - Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants Phase 2
Recruiting NCT06018311 - Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads N/A
Withdrawn NCT05431439 - Omics of Cancer: OncoGenomics
Completed NCT01343043 - A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma Phase 1
Completed NCT01938638 - Open Label Phase I Dose Escalation Study With BAY1143572 in Patients With Advanced Cancer Phase 1
Recruiting NCT05514444 - Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001) Phase 1
Recruiting NCT02292641 - Beyond TME Origins N/A
Terminated NCT00954512 - Study of Robatumumab (SCH 717454, MK-7454) in Combination With Different Treatment Regimens in Participants With Advanced Solid Tumors (P04722, MK-7454-004) Phase 1/Phase 2
Recruiting NCT04958239 - A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) Phase 1
Recruiting NCT04627376 - Multimodal Program for Cancer Related Cachexia Prevention N/A
Completed NCT01222728 - Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Recruiting NCT06004440 - Real World Registry for Use of the Ion Endoluminal System
Active, not recruiting NCT05636696 - COMPANION: A Couple Intervention Targeting Cancer-related Fatigue N/A
Not yet recruiting NCT06035549 - Resilience in East Asian Immigrants for Advance Care Planning Discussions N/A
Recruiting NCT06004466 - Noninvasive Internal Jugular Venous Oximetry
Completed NCT03190811 - Anti-PD-1 Alone or Combined With Autologous DC-CIK Cell Therapy in Advanced Solid Tumors Phase 1/Phase 2

External Links