PF-00477736 Is Being Studied In Advanced Solid Tumors In Combination With Chemotherapy With Gemcitabine

NCT00437203 | Terminated Phase 1 Results

• 1 other identifier: A8211001
• Study Type: interventional
• Target: 43
• Locations: 2 countries
• Sites: 7

Brief Summary

To determine the overall safety of PF-00477736 when given in combination with gemcitabine, a chemotherapy agent, in patients with advanced solid tumors and determine the maximum dose of PF-00477736 that can be safely given in combination with gemcitabine. This is the first study of PF-00477736 in humans.

Conditions

Neoplasms

Keywords

Advanced cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of PF-00477736 When Administered in Combination With Gemcitabine

  Up to Day 21 Cycle 1

Secondary Outcomes (10)

• Number of Participants With Objective Response (OR)

  Baseline, Day 15 of Cycle 2 and 4 and every 4 cycles thereafter up to Week 62

• Maximum Observed Plasma Concentration (Cmax)

  0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10

• Minimum Observed Plasma Trough Concentration (Cmin)

  0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10

• Time to Reach Maximum Observed Plasma Concentration (Tmax)

  0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start:Day 1, 8 Cycle 0 Cohort 1-3; 0(pre-dose), 0.25, 1, 2, 24, 24.25, 24.5, 25, 27, 29, 31, 48 hr post-infusion start:Day 1-2, 8-9 Cycle 0 Cohort 4-8; Day 2-3, 9-10 Cycle 1 Cohort 9-10

• Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-24)]

  0(pre-dose), 0.25, 1, 3, 3.25, 3.5, 4, 6, 8, 10, 24 hr post-infusion start: Day 1, 8 Cycle 0

Study Arms (1)

1

EXPERIMENTAL

Drug: PF-00477736; Drug: gemcitabine

Interventions

PF-00477736 DRUG

* Escalating doses of PF-00477736 will be administered intravenously on Days 2 and 9 and gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts). * If a patient is administered Cycle 0 - only PF-0047736 will be administered intravenously on Days 1 and 8 of a 21-day cycle for patients who have a 3-hour infusion and Days 1 and 8 of a 14-day cycle for patients who have a 24-hour infusion.

1

gemcitabine DRUG

gemcitabine will be administered intravenously on Days 1 and 8 of a 21-day cycle (doses to be evaluated range from 750 to 1250 mg/m2 in three separated cohorts).

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytopathological diagnosis of solid malignancy that is refractory to standard therapy or for which no curative therapy exists.
• ECOG performance status 0 or 1.
• Adequate blood cell counts, kidney function and liver function.

You may not qualify if:

• Prior treatment with gemcitabine.
• Uncontrolled brain metastases, spinal cord compression, carcinomatous meningitis, or leptomeningeal disease.
• NCI CTC Grade 2 or higher ARDS, non-infectious pneumonitis, or pulmonary fibrosis.
• NCI CTC Grade 2 or higher cardiovascular toxicities with the exception of NCI CTC Grade 3 hypertension that is well controlled.
• Known human immunodeficiency virus (HIV) seropositivity.
• Concurrent treatment with anticoagulants or known coagulopathy

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Pfizer Investigational Site

Los Angeles, California, 90095-6984, United States

Location

Pfizer Investigational Site

Los Angeles, California, 90095, United States

Location

Pfizer Investigational Site

Santa Monica, California, 90403, United States

Location

Pfizer Investigational Site

Santa Monica, California, 90404, United States

Location

Pfizer Investigational Site

New York, New York, 10022, United States

Location

Pfizer Investigational Site

New York, New York, 10065, United States

Location

Pfizer Investigational Site

East Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Neoplasms

Interventions

PF 00477736; Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

The study was prematurely terminated due to business reasons.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2007
• First Posted: February 19, 2007
• Study Start: December 1, 2006
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 3, 2012
• Results First Posted: April 3, 2012

Record last verified: 2012-03

Locations

US (6); AU (1)