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Dacomitinib for Treatment of Patients in India With Metastatic Non Small Cell Lung Cancer With EGFR Activating Mutations

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ClinicalTrials.gov Identifier: NCT04511533
Recruitment Status : Recruiting
First Posted : August 13, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is a Phase 4, open label, single arm, multi-center, prospective clinical trial of dacomitinib that will be performed in India. This study will enroll a sufficient number of participants to ensure that 100 participants are treated with dacomitinib. The primary objective of this study is to assess the safety and tolerability of dacomitinib. The secondary objective is to evaluate antitumor activity of dacomitinib by objective response rate and duration of response.

Condition or disease Intervention/treatment Phase
Metastatic Non Small Cell Lung Cancer Drug: Dacomitinib Phase 4

Detailed Description:

This is a Phase 4, open label, single arm, multi-center, prospective clinical trial of dacomitinib that will be performed in India. This study will enroll a sufficient number of participants to ensure that 100 participants are treated with dacomitinib. The primary objective of this study is to assess the safety and tolerability of dacomitinib. The secondary objective is to evaluate antitumor activity of dacomitinib by objective response rate and duration of response. Drug administration: Dacomitinib will be supplied by Pfizer and administered in accordance with the India Local Product Document (LPD). The recommended dosage of dacomitinib is 45 mg taken orally once a day at approximately the same time each day, until disease progression, participant refusal/lost to follow-up, or unacceptable toxicity occurs.

STUDY PROCEDURES:

Screening: Participants will be screened within 28 days prior to first dosing of dacomitinib to confirm that they meet the eligibility criteria for the study.

Follow-up Visit: All participants will return to the study site up to 28 days after the last dose of study drug administration for assessment of potential AEs, recording of concomitant treatment use and to confirm appropriate contraception usage.

ASSESSMENTS Tumor Assessments: Tumor assessments will include all known or suspected disease sites. Computerized tomography (CT) or Magnetic resonance imaging (MRI) scans of Chest Abdomen and Pelvis and MRI of the brain will be performed at Screening and repeated every 12 weeks ±1 week until the end of treatment. For all tumor assessments, the method of assessment that was used at Screening will be used throughout the study. Tumor assessment will be repeated at the end of treatment if more than 6 weeks have passed since the last evaluation. Assessment of response will be made using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Confirmation of response will be required ≥4 weeks after initial response is observed.

Safety Assessments: The following parameters will be assessed - Physical examination, vital signs, Eastern Cooperative Oncology Group Performance score (ECOG PS), safety lab data, 12 lead electrocardiogram (ECG). Unscheduled clinical laboratory measurements may be obtained at any time during the study to assess any perceived safety concerns.

Adverse event reporting: All observed or volunteered AEs regardless of treatment group or suspected causal relationship to the investigational product(s) will be reported as per regulatory requirements.

End of Study: The end of study is defined as 1 year after the last participant first visit (LPFV) date in the study. At the end of study, participants who are on treatment and benefiting from dacomitinib treatment will be switched to commercially available dacomitinib if considered appropriate by the investigator, as soon as feasible.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SINGLE ARM STUDY TO EVALUATE THE SAFETY OF DACOMITINIB FOR THE FIRST-LINE TREATMENT OF PARTICIPANTS IN INDIA WITH METASTATIC NON-SMALL CELL LUNG CANCER WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR)-ACTIVATING MUTATIONS
Actual Study Start Date : August 27, 2020
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : August 1, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Dacomitinib

Arm Intervention/treatment
Experimental: Treatment Arm
The recommended dosage of dacomitinib is 45 mg taken orally once a day at approximately the same time each day, until disease progression, participant refusal/lost to follow-up, or unacceptable toxicity occurs.
Drug: Dacomitinib
Dacomitinib is a kinase inhibitor indicated for the first line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.
Other Name: DACOPLICE




Primary Outcome Measures :
  1. Incidence of Adverse events (AEs) [ Time Frame: From the time of first dose to 28 days post last dosing date or the date of initiation of a new anticancer therapy, whichever occurs first ]
    The incidence of adverse events will be assessed for all participants who receive at least one dose of dacomitinib, regardless of dosing interruptions or dosing compliance.


Secondary Outcome Measures :
  1. Confirmed Objective Response Rate (ORR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 [ Time Frame: From time of first dose until disease progression, death or initiation of a new anticancer therapy, whichever occurs first, assessed for up to 3 years ]
    The secondary outcome measure is the treatment effect of dacomitinib as assessed by the investigator for all participants who receive at least one dose of dacomitinib without regard to tolerability or discontinuation from treatment.

  2. Confirmed Duration of Response (DoR) as assessed by the investigator using Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 [ Time Frame: From time of first tumor response until disease progression, death or initiation of a new anticancer therapy, whichever occurs first, assessed for up to 3 years ]
    The secondary outcome measure is the treatment effect of dacomitinib as assessed by the investigator for all participants who receive at least one dose of dacomitinib without regard to tolerability or discontinuation from treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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. Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC with EGFR activating mutations as detected by an appropriate test.
  2. No prior treatment with systemic therapy and EGFR/Other Tyrosine Kinase Inhibitors (TKIs) for metastatic NSCLC.
  3. Participants with asymptomatic Central Nervous System (CNS) metastases (including participants controlled with stable or decreasing steroid use within the last 2 weeks prior to study entry) will be eligible.
  4. Age >=18 years.
  5. ECOG PS of 0-2.
  6. Adequate . hematologic, renal, liver function: ANC >= 1000/mm3; Platelets>=50000/mm3; Hb >=8 g/dL; est. Cr.Cl >=30 mL/min; Total serum bilirubin <1.5 × ULN; AST,ALT <=2.5 × ULN; (<=5.0 × ULN, if liver metastases).
  7. Acute effects of any prior therapy resolved to baseline severity or to Common Terminology Criteria for Adverse Events (CTCAE) Grade <1 except for AEs that in the investigator's judgment do not constitute a safety risk for the participant.
  8. Serum or urine pregnancy test (for females of childbearing potential) negative at Screening.

Exclusion Criteria:

  1. Any evidence of mixed histology that includes elements of small cell or carcinoid lung cancer.
  2. Any other mutation other than exon 19 deletion or L858R in exon 21, with or without the presence of the exon 20 T790M mutation.
  3. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Prior irradiation to >25% of the bone marrow.
  4. Major surgery within 4 weeks prior to first dose of dacomitinib. Minor surgical procedures (eg, port insertion) are not excluded, but sufficient time should have passed for adequate wound healing.
  5. Known prior or suspected severe hypersensitivity to dacomitinib or any component of its formulation.
  6. History or known presence of interstitial fibrosis, interstitial lung disease, pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, obliterative bronchiolitis, and pulmonary fibrosis.
  7. Other severe acute or chronic medical or psychiatric condition, that may interfere with the interpretation of study results and, would make the participant inappropriate for entry into this study.
  8. Evidence of active malignancy (other than current NSCLC) within the last 3 years prior to first dose of dacomitinib.
  9. Breastfeeding female participants.
  10. Pregnant female participants; male participants able to father children and female participants of childbearing potential who are unwilling or unable to use contraception method per protocol

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): NCT04511533


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

Locations
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India
Rajiv Gandhi Cancer Institute And Research Centre Recruiting
New Delhi, Delhi, India, 110085
The Gujarat Cancer and Research Institute Recruiting
Ahmedabad, Gujarat, India, 380016
Hemato Oncology Clinic Ahmedabad Pvt. Ltd Not yet recruiting
Ahmedabad, Gujarat, India, 380054
Artemis Hospital Recruiting
Gurugram, Haryana, India, 122001
National Cancer Institute Recruiting
Nagpur, Maharashtra, India, 441108
Apex Wellness Hospital Recruiting
Nashik, Maharashtra, India, 422009
Sahyadri Super Speciality Hospital Recruiting
Pune, Maharashtra, India, 41004
Grant Medical Foundation, Ruby Hall Clinic Recruiting
Pune, Maharashtra, India, 411001
Bhaktivedanta Hospital and Research Institute Recruiting
Thane, Maharashtra, India, 401107
Yashoda Hospital Not yet recruiting
Hyderabad, Telangana State, India, 500082
Tata Medical Center Recruiting
Kolkata, WEST Bengal, India, 700160
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: NCT04511533    
Other Study ID Numbers: A7471064
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
URL: 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: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Dacomitinib
Metastatic Non Small Cell Lung Cancer
EGFR-activating mutations
NSCLC
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms