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PCA062 in pCAD-positive 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: NCT02375958
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
A first-in-human sttudy using PCA062 in patients with p-CAD positive solid tumors.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Head & Neck Cancer Esophageal Cancer Drug: PCA062 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Multi-center, Open-label Dose Escalation and Expansion Study of PCA062 Administered Intravenously in Adult Patients With p-CAD Positive Tumors
Actual Study Start Date : April 15, 2015
Actual Primary Completion Date : July 17, 2018
Actual Study Completion Date : July 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Triple Negative Breast Cancer Drug: PCA062
Experimental: Head and Neck Cancer Drug: PCA062
Experimental: Esophageal Cancer Drug: PCA062



Primary Outcome Measures :
  1. Incidence rate of dose limiting toxicities [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Incidence and severity of serious/adverse events [ Time Frame: Duration of study (each treatment cycle = 14 days) ]
  2. Pharmacokinetic parameter Cmax [ Time Frame: 84 days ]
    Cmax = the maximum concentration (peak) of the drug observed in the blood after a single administration of the drug

  3. Presence of PCA062 anti-bodies [ Time Frame: 84 days ]
    The presence and/or concentration of the anti-bodies will be tested from the blood samples collected

  4. Overall response rate [ Time Frame: Duration of study (each treatment cycle = 14 days) ]
  5. Duration of response [ Time Frame: Duration of study (each treatment cycle = 14 days) ]
  6. Progression free survival [ Time Frame: 18 months ]
  7. Disease control rate [ Time Frame: 18 months ]
  8. Best overall response [ Time Frame: Duration of study (each treatment cycle = 14 days) ]
  9. Pharmacokinetic paramater Tmax [ Time Frame: 84 days ]
    Tmax = the time the drug takes to reach maximum (peak) concentration in the blood



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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:

  1. Male or female ≥ 18 years of age
  2. Documented pCAD expressing tumor cells with the exception of HNSCC and ESCC. An archived tumor sample collected within 36 months prior to baseline if available, or a new tumor biopsy sample must be available for molecular pre-screening.
  3. Consent for a tumor biopsy at screening
  4. Progressive disease and no effective therapy exists
  5. Measurable disease as per RECIST v1.1 criteria
  6. ECOG Performance status of ≤ 2

Exclusion criteria:

  1. CNS metastatic involvement
  2. Clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological conditions.
  3. A history of serious allergic reactions, which in the opinion of the investigator pose an increased risk of serious infusion reactions.
  4. Monocular vision or has media opacities or any other condition that precludes monitoring of the retina or the fundus, or has a history of ophthalmology exam with retina or cornea abnormalities
  5. Previously treated with anti-pCAD biologic therapies.
  6. Received anti-cancer therapies within the following time frames prior to the first dose of study treatment:

    • Conventional cytotoxic chemotherapy: ≤4 weeks
    • Biologic therapy (eg, antibodies), other than ADCs: ≤4 weeks
    • Non-cytotoxic small molecule therapeutics: ≤5 T1/2 or ≤2 weeks (whichever is longer)
    • Other investigational agents: ≤4 weeks
    • Radiation therapy (palliative setting is allowed.): ≤4 weeks
    • Major surgery: ≤2 weeks
  7. Patient has out of range laboratory values defined as:

    • Hematological values:
    • Absolute neutrophil count (ANC) <1.5 x 109/L
    • Hemoglobin (Hgb) <9 g/dL
    • Platelets <100 x 109/L
    • Hepatic and renal function
    • Total bilirubin >1.5 x upper limit of normal (ULN). For patients with Gilbert's syndrome, total bilirubin >2.5 x ULN.
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x ULN for patients without tumor involvement of the liver or >5 x ULN for patients with tumor involvement of the liver.
    • Serum creatinine >1.5 x ULN and/or measured creatinine clearance < 40 ml/min

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): NCT02375958


Locations
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United States, Texas
Novartis Investigative Site
Houston, Texas, United States, 77030
Novartis Investigative Site
San Antonio, Texas, United States, 78229
France
Novartis Investigative Site
Villejuif Cedex, France, 94805
Italy
Novartis Investigative Site
Milano, MI, Italy, 20133
Japan
Novartis Investigative Site
Koto ku, Tokyo, Japan, 135 8550
Singapore
Novartis Investigative Site
Singapore, Singapore, 169610
Spain
Novartis Investigative Site
Madrid, Spain, 28009
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02375958     History of Changes
Other Study ID Numbers: CPCA062X2101
2014-003732-40 ( EudraCT Number )
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Novartis ( Novartis Pharmaceuticals ):
PCA062
Triple Negative Breast Cancer
Head & Neck Cancer
Esophageal Cancer
pCAD, pcadherin, solid-tumors

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Esophageal Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Breast Neoplasms
Breast Diseases
Skin Diseases