Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007849

Trial Description

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Title

A Randomized, Double-blind, Placebo-controlled, Phase 2 Clinical Trial of Alisertib (MLN8237) in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel as Second Line Therapy for Small Cell Lung Cancer (SCLC).

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This is a two-arm, randomized, double-blind, placebo-controlled, multicenter, phase 2 study
designed to evaluate the efficacy and safety of alisertib, an Aurora A kinase inhibitor, in
combination with paclitaxel compared with placebo + paclitaxel in patients with SCLC who
have relapsed or did not respond to first line standard therapy.

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Brief Summary in Scientific Language

Randomization will be stratified by the type of relapse after primary treatment (sensitive
or resistant/refractory disease) and presence of brain metastases.

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Organizational Data

  •   DRKS00007849
  •   2015/05/18
  •   2013/12/04
  •   no
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Secondary IDs

  •   U1111-1154-9805 
  •   2013-003713-18 
  •   NCT02038647  (ClinicalTrials.gov)
  •   C14018  (Millennium Pharmaceuticals, Inc.)
  •   2013-003713-18 
  •   U1111-1154-9805 
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Health Condition or Problem studied

  •   Small Cell Lung Cancer (SCLC)
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Drug: Alisertib (MLN8237)
  •   Drug: Placebo
  •   Drug: Paclitaxel 60 mg/m2
  •   Drug: Paclitaxel 80 mg/m2
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- Progression-free survival (PFS); time frame: Up to 22 months

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Secondary Outcome

- Overall survival (OS); time frame: Up to 22 months
- Overall response rate (ORR), including complete response rate (CRR); time frame: Duration of study until disease progression up to 22 months.
- Safety and health related quality of life (HRQOL); time frame: From screening period to the specified number of PFS events up to 22 months.
- Biomarker correlative studies including circulating tumor cells and circulating DNA assessments; time frame: Twice in cycle 1 in a 28-day cycle
- Disease control rate (DCR); time frame: From screening period to 30 days after last dose of study drug up to 22 months.
- Duration of response (DOR); time frame: From screening period to 30 days after last dose of study drug up to 22 months.

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Countries of Recruitment

  •   United States
  •   Belgium
  •   Canada
  •   Czech Republic
  •   France
  •   Germany
  •   Hungary
  •   Italy
  •   Poland
  •   Spain
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Locations of Recruitment

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Recruitment

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  •   2014/02/27
  •   166
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Inclusion Criteria

Each patient must meet all the following inclusion criteria to be enrolled in the study:

1. Male or female patients ≥ 18 years old

2. Have a pathologically (histology or cytology) confirmed diagnosis of SCLC

3. Have received and progressed after a platinum-based standard chemotherapy regimen for
first line treatment of SCLC, either limited stage (LS) or extensive stage (ES).

4. Have measurable disease within ≤ 2 weeks before randomization. Clear radiographic
evidence of disease progression after initial therapy should have been documented.

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (PS 0-1).

6. Patients with treated brain metastases (surgery, whole or stereotactic brain
radiation) are allowed provided the lesions have been stable for at least 2 weeks and
the patient is off steroids or is on a stable dose of steroids. Patients should be
without neurologic dysfunction that would confound the evaluation of neurological
and/or other AEs.

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Exclusion Criteria

Exclusion Criteria

Patients meeting any of the following exclusion criteria are not to be randomized to
treatment:

1. Any prior therapy for second-line treatment of SCLC.

2. Patients who relapsed ≥ 180 days after their response to first-line treatment.

3. Prior treatment with an Aurora A specific-targeted or pan-Aurora-targeted agent,
including alisertib, or any other investigational agent.

4. Prior treatment with paclitaxel or any other taxane agent.

5. Known hypersensitivity to Cremophor® EL, paclitaxel, or its components.

6. Any comorbid condition or unresolved toxicity that would preclude administration of
alisertib or weekly paclitaxel.

7. Prior history of ≥ Grade 2 neurotoxicity that is not resolved to ≤ Grade 1

8. Patients with symptomatic and/or progressive brain metastases or with carcinomatous
meningitis.

9. Treatment with clinically significant enzyme inducers within 14 days prior to the
first dose of alisertib and during study conduct. Major prohibited enzyme inducers
include: phenytoin, carbamazepine, phenobarbital, rifampin, rifabutin, rifapentine,
and St. John's wort.

10. Inability to swallow alisertib or other orally administered medications.

11. Requirement for administration of proton pump inhibitor (PPI), H2 antagonist, or
pancreatic enzymes.

12. Diagnosed with or treated for another malignancy within 2 years before the first dose
of study drug, or previously diagnosed with another malignancy and have any evidence
of residual disease.

13. Other severe acute or chronic medical or psychiatric condition(s) per protocol.

14. History of myocardial infarction, unstable symptomatic ischemic heart disease,
uncontrolled hypertension despite appropriate medical therapy, any ongoing cardiac
arrhythmias of Grade > 2, thromboembolic events (eg, deep vein thrombosis, pulmonary
embolism, or symptomatic cerebrovascular events), or any other cardiac condition (eg,
pericardial effusion or restrictive cardiomyopathy) within 6 months before receiving
the first dose of study drug.

15. Known history of human immunodeficiency virus (HIV) infection, hepatitis B or
hepatitis C.

16. Surgery within 3 weeks (or 2 weeks for a minor surgery) before study enrollment and
not fully recovered to baseline or to a stable clinical status.

17. Patients who are pregnant, lactating, or do not agree to use effective methods of
contraception during the study treatment period through 6 months after the last dose
of study drug per protocol.

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Addresses

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    • Millennium Pharmaceuticals, Inc.
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    • Millennium Pharmaceuticals, Inc.
    • Medical Monitor 
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    • For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2015/02/24
* This entry means the parameter is not applicable or has not been set.