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Dose Escalation Study of BI 2536 With Pemetrexed in Previously Treated Patients With Non-small-cell Lung Cancer

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. Identifier: NCT02211833
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
Exploratory evaluation of safety, tolerability, pharmacokinetics (PK), maximum tolerated dose (MTD), and efficacy of BI 2536 administered in combination with pemetrexed

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: BI 2536 Drug: Pemetrexed Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open-label Dose Escalation Study of Intravenous BI 2536 Together With Pemetrexed in Previously Treated Patients With Non-small-cell Lung Cancer
Study Start Date : October 2006
Actual Primary Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BI 2536 with pemetrexed
combination therapy phase may be followed by BI 2536 monotherapy for eligible patients
Drug: BI 2536
Drug: Pemetrexed

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of BI 2536 in combination with pemetrexed [ Time Frame: up to 3 weeks ]
    by occurrence of dose limiting toxicities (DLT)

  2. Number of patients with adverse events during combination therapy [ Time Frame: up to 20 weeks ]
    according to common terminology criteria for adverse events (CTCAE) 3.0

Secondary Outcome Measures :
  1. Objective tumor response after combination therapy [ Time Frame: up to 20 weeks ]
    according to Response Evaluation Criteria in Solid Tumours (RECIST)

  2. Duration of objective tumor response after combination therapy [ Time Frame: up to 1 year ]
  3. Progression free survival (PFS) [ Time Frame: up to 2 years ]
  4. Overall survival [ Time Frame: up to 2 years ]
  5. Number of patients with abnormal laboratory findings [ Time Frame: up to 20 weeks ]
  6. Change in Eastern Cooperative Oncology Group (ECOG) performance score [ Time Frame: baseline, up to 1 year ]

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

Inclusion Criteria:

  1. Pathologic or cytologic confirmed diagnosis of NSCLC
  2. Recurrent, advanced or metastatic NSCLC that had progressed following 1 prior chemotherapy regimen for advanced disease. Patients could have received prior adjuvant chemotherapy as long as the disease free interval was longer than 1 year.
  3. Measurable disease by 1 or more techniques (CT, MRI) according to RECIST criteria
  4. Male or female aged 18 years or older
  5. Life expectancy of at least 3 months
  6. Eastern Cooperative Oncology Group (ECOG) performance score 0-2
  7. Written informed consent that was consistent with International Conference on Harmonization (ICH) - Good Clinical Practice (GCP) guidelines

Exclusion Criteria:

  1. Treatment with an investigational drug in another clinical study within the 28 days prior to the start of therapy or concomitantly with this study
  2. Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the 28 days prior to Day 1 of treatment period 1 of this trial
  3. Any persisting toxicities that were deemed to be clinically significant from the previous therapy
  4. Received more than 1 prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients could have received prior epidermal growth factor receptor tyrosine kinase inhibitors
  5. Unwilling or unable to take folic acid and vitamin B12 supplementation
  6. Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids). Patients who had received prior whole brain irradiation and whose brain metastases were stable according to the criteria above were not excluded
  7. Other active malignancy diagnosed within the past 3 years (other than non-melanomatous skin cancer and cervical intraepithelial neoplasia)
  8. Concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would have limited compliance with trial requirement or which were considered relevant for the evaluation of the efficacy or safety of the trial drug
  9. Unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to the day of and up to 2 days after the administration of pemetrexed
  10. Received prior therapy with pemetrexed
  11. Absolute neutrophil count (ANC) ≤1 500/μL, platelet count ≤100 000/μL, or haemoglobin <9 mg/dL
  12. Total bilirubin >1.5 mg/dL (26 μmol/L), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2.5 x the upper limit of normal (ULN), except in cases of known liver metastasis where a maximum 5 x ULN was acceptable
  13. Serum creatinine level >1.5 mg/dL and or creatinine clearance <45 mL/min
  14. Sexually active and unwilling to use a medically acceptable method of contraception
  15. Pregnancy or breast feeding
  16. Known or suspected active alcohol or drug abuse
  17. Unable to comply with the protocol
  18. Any known hypersensitivity to the trial drugs or their excipients
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02211833    
Other Study ID Numbers: 1216.5
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors