A Safety Study Of A Monoclonal Antibody Against A5B1 Integrin In Solid Tumors

NCT00915278 | Terminated Phase 1 Results

• 1 other identifier: B1001001
• Study Type: interventional
• Target: 33
• Locations: 2 countries
• Sites: 7

Brief Summary

Dose finding study of the MoaB PF-04605412 directed against the alpha5beta1 integrin. Main objective is to define the MTD (maximum tolerated dose) or MAD (maximum administrable dose) in cancer patients pre treated or unresponsive to standard therapies.

Conditions

Advanced Non-Hematologic Malignancies

Keywords

Neoplasms; monoclonal antibody; PF-04605412; advanced metastatic solid tumors

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose-limiting Toxicities (DLT)

  DLT was defined as any of the following events occurring during the first 28 days of study medication and considered at least possibly-related to study medication: any grade 3 or 4 clinically-relevant non-hematologic toxicity,any \>= Grade 3 adverse event (AE) graded by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 3.0 without a clear alternative explanation to study treatment relationship occurring during the first 6 weeks of treatment with PF-04605412. DLT was used to determine maximum tolerated dose (MTD) in this study.

  Baseline up to 6 weeks PF-04605412

Secondary Outcomes (22)

• Maximum Observed Serum Concentration (Cmax)

  Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

  Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1

• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)]

  Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1

• Serum Decay Half-Life (t1/2)

  Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1

• Time to Reach Maximum Observed Serum Concentration (Tmax)

  Predose, 1, 2, 2.5, 3, 6, 10, 24 hours after the start of infusion on Day 1; Days 3, 5, 8, 11, 15, 22 of Cycle 1

Study Arms (1)

PF-04605412

EXPERIMENTAL

Drug: PF-04605412

Interventions

PF-04605412 DRUG

PF-04605412 will be administered as 2 hr IV infusion every 4 or 2 weeks. Start dose is 7.5 mg. Multiple doses are foreseen. Treatment will continue until intolerable toxicity, progression of disease or patient's refusal

PF-04605412

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed advanced measurable or evaluable solid tumors unresponsive to currently available therapies, or for which there is no curative therapy
• Eastern Cooperative Oncology Group (ECOG) performance status 0 and 1
• Life expectancy more than12 weeks
• Adequate bone marrow, liver and renal function

You may not qualify if:

• Known brain metastasis
• Chemotherapy, radiotherapy, or any investigational cancer therapy within 4 weeks of start of screening procedures
• Major surgical procedure within 4 weeks of start of screening procedures
• Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 6 months

Sponsors & Collaborators

• Pfizer: lead

Study Sites (7)

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232-5536, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232-7610, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

Location

Pfizer Investigational Site

Tooting, London, SW17 0QT, United Kingdom

Location

Pfizer Investigational Site

North Cheam, Surrey, SM3 9DW, United Kingdom

Location

Pfizer Investigational Site

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Neoplasms

Interventions

PF-04605412

Limitations and Caveats

This study was terminated prematurely because PK data did not enable sufficient confidence in producing desired clinical benefit. Potential re-occurrence of cytokine mediated infusion reaction at higher doses did not support further development.

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 8, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 4, 2014
• Results First Posted: April 4, 2014

Record last verified: 2014-02

Locations

GB (3); US (4)