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Trial record 24 of 201 for:    Ovarian Dysgenesis 1

A Study Of PF-06664178 In Patients With Advanced 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02122146
Recruitment Status : Terminated (The study was prematurely discontinued due to a business-related decision on 09-FEB-2016. The decision to terminate the trial was based on the overall results.)
First Posted : April 24, 2014
Results First Posted : February 16, 2018
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
To assess the safety and tolerability at increasing dose levels of PF-06664178 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: PF-06664178 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Dose Escalation Study Of Pf-06664178 In Patients With Locally Advanced Or Metastatic Solid Tumors
Actual Study Start Date : August 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PF-06664178
Experimental
Drug: PF-06664178
Part 1 - PF-06664178 will be administered intravenously every 21 days in cohorts of 2 or more patients starting at a dose of 0.15 mg/kg. Increases in dose will continue until MTD is determined.

Drug: PF-06664178
Part 2 - patients with select tumor types (Non Small Cell Lung Cancer ovarian cancer, and breast cancer ) will be treated at the MTD selected in Part 1.




Primary Outcome Measures :
  1. First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD) [ Time Frame: Day 1 up to Day 21 ]
    Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.

  2. Number of Patients With All-Causality Treatment-Emergent Adverse Events(TEAEs) [Part 2 & 3] [ Time Frame: Day 1 up to Day 21 ]
    An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.

  3. Number of Participants With Laboratory Abnormalities [Part 2 & 3] [ Time Frame: On Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued) ]
    Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.


Secondary Outcome Measures :
  1. Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs ) [Part 1] [ Time Frame: From screening up to 28 days after the last treatment administration in each cycle, and follow-up visits(At least 28 days and no more than 35 days after discontinuation of treatment) ]
    An adverse event (AE) was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. TEAEs were those AEs with initial onset or increasing in severity after the first dose of study drug.

  2. Number of Participants With Laboratory Abnormalities[Part 1] [ Time Frame: Screening; on Day1, Day4, Day8, Day15 of the first cycle; on Day1, Day8, Day15 of the second cycle; on Day 1 of the subsequent cycles; end of treatment visit(no longer than 1 week after the patient has been discontinued) ]
    Number of participants with a laboratory abnormality meeting specified criteria. The laboratory test included: hematology( hemoglobin, platelets, white blood cell count, absolute neutrophils, absolute lymphocytes, absolute monocytes, absolute eosinophils, absolute basophils), chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate), coagulation (prothrombin time or International normalized ratio, partial thromboplastin time), Urinalysis (urine protein, urine blood) and pregnancy test.

  3. Overall Incidence of Anti-PF-06664178-Antibodies[Part 1] [ Time Frame: Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment ]
    Number of participants with the presence of anti-PF-06664178 antibodies

  4. Overall Incidence of Anti-PF-06664178-Antibodies [Part 2 & 3] [ Time Frame: Day 1, 15, 21, and every 21 days thereafter up to 24 months, and end of treatment ]
    Number of participants with the presence of anti-PF-06664178 antibodies

  5. Overall Number of Participants With Objective Tumor Response[Part 1] [ Time Frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months ]
    Objective tumor response, was assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate, and Prolonged Stable Disease. The criterion is defined as: Objective Progression(PD):20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5mm; Stable (SD): All target lesions must be assessed. Stable can follow PR only in the rare case that the sum increases by less than 20% from the nadir, but enough that a previously documented 30% decrease no longer holds; symptomatic deterioration(Sym):Participants with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time; Indeterminate (In):Progression has not been determined and one, or more non-target sites were not assessed, or assessment methods were inconsistent with those used at baseline.

  6. Overall Number of Participants With Objective Tumor Response [Part 2 & 3] [ Time Frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months ]
    Objective tumor response, as assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 by calculating the Overall Response Rate (ORR), and Prolonged Stable Disease (SD).No Progression Free Survival (PFS) was completed. The criterion is as follow: Objective Progression(PD), Stable (SD), symptomatic deterioration(Sym), and Indeterminate (In)

  7. Maximum Observed Plasma Concentration (Cmax) for PF-06664178 [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    Cmax of PF-06664178 was observed directly from data

  8. Maximum Observed Plasma Concentration (Cmax) for Total Antibody (PF-06479118) [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    Cmax of total antibody PF-06479118 was observed directly from data

  9. Maximum Observed Plasma Concentration (Cmax) for Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    Cmax of unconjugated payload PF-06380101 was observed directly from data

  10. Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of PF-06664178 [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval

  11. Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Total Antibody(PF-06479118) [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval.

  12. Area Under the Concentration-Time Curve Over the Dosing Interval(AUCtau) of Unconjugated Payload(PF-06380101) [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    AUCtau refers to area under the concentration-time profile from time zero to the time tau, the dosing interval.

  13. Systemic Clearance (CL) of PF-06664178 [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

  14. Systemic Clearance (CL) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

  15. Systemic Clearance (CL) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

  16. Volume of Distribution (Vss) of PF-06664178 [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

  17. Volume of Distribution (Vss) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

  18. Volume of Distribution (Vss) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

  19. Terminal Elimination Half-Life (t1/2) of PF-06664178 [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half

  20. Terminal Elimination Half-Life (t1/2) of Total Antibody (PF-06479118)[Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half

  21. Terminal Elimination Half-Life (t1/2) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half

  22. Trop-2 Expression Levels on Archived Tissue [Part 2 & 3] [ Time Frame: Day 1 ]
    Number of participents meeting the following criterion for Trop-2 expression assessment : low expression, medium expression and high expression

  23. Accumulation Ratio (Rac) of PF-06664178 [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.

  24. Accumulation Ratio (Rac) of Total Antibody (PF-06479118) [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.

  25. Accumulation Ratio (Rac) of Unconjugated Payload (PF-06380101) [Part 1 ,2 & 3] [ Time Frame: 0, 1, 4, 24 hours post-dose on Day 1, and on Day 4, Day 8 and Day 15 of cycles 1 and 4; 0, 1hour post-dose on Cycle 2, 3 and every cycle after cycle 4, end of treatment ]
    Accumulation ratio refers to AUCtau for cycle 4/AUCtau for cycle 1, where AUCtau is defined as area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to the time tau, the dosing interval.



Information from the National Library of Medicine

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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:

  • Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available
  • Performance Status of 0 or 1
  • Adequate bone marrow, kidney and liver function
  • Part 2 includes target expressing NSCLC, ovarian or breast cancer patients

Exclusion Criteria:

  • Brain metastases requiring steroids
  • Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start (6 weeks for mitomycin C or nitrosoureas)
  • Active and clinically significant bacterial, fungal, or viral infection

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): NCT02122146


Locations
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United States, California
Keck Hospital of USC
Los Angeles, California, United States, 90033
LAC&USC Medical Center
Los Angeles, California, United States, 90033
USC/Norris Comprehensive Cancer Center / Investigational Drug Services
Los Angeles, California, United States, 90033
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, Colorado
Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
University of Colorado Denver CTO (CTRC)
Aurora, Colorado, United States, 80045
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
University of Washington Medical Center
Seattle, Washington, United States, 98195
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: NCT02122146     History of Changes
Other Study ID Numbers: B7401001
2015-002704-84 ( EudraCT Number )
First Posted: April 24, 2014    Key Record Dates
Results First Posted: February 16, 2018
Last Update Posted: February 16, 2018
Last Verified: August 2017
Keywords provided by Pfizer:
ovarian cancer
Phase 1
ADC
PF-06664178
solid tumors
tumors
neoplasm metastasis
NSCLC
non small cell lung cancer
OVCA
breast cancer
Additional relevant MeSH terms:
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Neoplasms