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PF-06804103 Dose Escalation in HER2 Positive Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03284723
Recruitment Status : Recruiting
First Posted : September 15, 2017
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of PF-06804103 in patients with HER2 positive solid tumors. The study will expand to look at the selected dose in patients with breast cancer, gastric cancer and non-small cell lung cancer

Condition or disease Intervention/treatment Phase
Breast Neoplasms Stomach Neoplasms Esophagogastric Junction Neoplasm Carcinoma, Non-small-cell Lung Drug: PF-06804103 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A PHASE 1 DOSE ESCALATION STUDY EVALUATING THE SAFETY AND TOLERABILITY OF PF-06804103 IN PATIENTS WITH HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2) POSITIVE SOLID TUMORS
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : September 14, 2021
Estimated Study Completion Date : September 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PF-06804103
Study Treatment
Drug: PF-06804103
Dose Escalation Phase - Part 1

Drug: PF-06804103
Dose Expansion Phase - Part 2




Primary Outcome Measures :
  1. Number of participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Baseline through Day 21 ]
    First cycle DLTs in order to determine the maximum tolerated dose


Secondary Outcome Measures :
  1. Maximum Observed Concentration (Cmax) [ Time Frame: Cycle 1 Day 1 0, 1 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months ]
  2. Time to reach maximum observed concentration (Tmax) [ Time Frame: Cycle 1 Day 1 0, 1 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months ]
  3. Incidence and titers of anti-drug antibodies [ Time Frame: Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 (each cycle is 21 days) up to 24 months ]
  4. Incidence and titers of neutralizing antibodies [ Time Frame: Cycle 1 Day 1, Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 (each cycle is 21 days) up to 24 months ]
  5. Number of participant with objective response [ Time Frame: Baseline and every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months ]
  6. Number of patients with progression free survival [ Time Frame: Baseline and every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months ]
  7. HER2 expression level in patients with documented anti-tumor activity [ Time Frame: Baseline and Cycle 3 Day 1 (each cycle is 21 days) ]
  8. Area under the curve from time zero to end of dosing interval (AUCtau) [ Time Frame: Cycle 1 Day 1 0, 1 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months ]
  9. Area under the concentration-time curve from time 0 to the last measurable concentration (AUClast) [ Time Frame: Cycle 1 Day 1 0, 1 4, and 24 hours, Day 4, Day 8 and Day 15, Cycle 2 Day 1 0 and 1 hour, Cycle 3 Day 1 0 and 1 hour, Cycle 4 Day 1 0, 1, 4 and 24 hour, Day 4, Day 8, Day 15, and Day 1 0 and 1 hour of subsequent cycles (cycle is 21 days) up to 24 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HER2 positive breast cancer or gastric cancer that is resistant to standard therapy or for which no standard therapy is available
  • NSCLC (part 2 only)
  • Performance status of 0 or 1
  • Adequate bone marrow, kidney and liver function

Exclusion Criteria:

  • Known CNS disease including, but not limited to, metastases
  • History of exposure to certain cumulative doses of anthracyclines
  • Grade 3 or higher hypersensitivity reaction to prior receipt of any antibody therapy
  • Active and clinically significant bacterial, fungal, or viral infection
  • Abnormal cardiac function defined by a LVEF <50% by ECHO or MUGA
  • Patients with previous history or active interstitial lung disease or pulmonary fibrosis, or a history of other clinically significant lung diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284723


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 20 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03284723    
Other Study ID Numbers: C0541001
2017-002538-22 ( EudraCT Number )
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
PF-06804103
HER2
ADC
breast cancer
gastric cancer
esophagogastric cancer
non-small cell lung cancer
neoplasms
solid tumors
human epidermal growth receptor 2
NSCLC
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Stomach Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases