Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003458

Trial Description

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Title

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of ALD518 in the Reduction of Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concomitant Chemotherapy and Radiotherapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the
course of oral mucositis in subjects with head and neck cancer receiving concomitant
chemotherapy and radiotherapy

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003458
  •   2012/10/19
  •   2011/07/25
  •   no
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Secondary IDs

  •   2011-002669-40 
  •   NCT01403064  (ClinicalTrials.gov)
  •   ALD518-CLIN-009  (Alder Biopharmaceuticals, Inc.)
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Health Condition or Problem studied

  •   Oral Mucositis
  •   K12.3 -  Oral mucositis (ulcerative)
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Interventions/Observational Groups

  •   Biological: ALD518
  •   Drug: 0.9% saline
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Safety and tolerability of ALD518, including incidence of adverse events, serious adverse events and clinically significant laboratory abnormalities; time frame: Participants will be followed for the duration of the trial, an expected average of 12 months
- Clinically assessed ulcerative OM (Who Grade ≥ 2) at a cumulative radiation dose of 55 Gy; time frame: The average time of this assessment will be 5-7 weeks after the initiation of RT

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Secondary Outcome

- Secondary efficacy endpoint of OM assessments; time frame: Measured from onset of OM through Week 4 Post-RT; Ulcerative (WHO Grade ≥ 2) and severe (WHO Grade ≥ 3) OM at cumulative doses of 35 Gy, 45 Gy, 55 Gy and 65 Gy; Duration of ulcerative and severe OM, Time of onset of ulcerative and severe OM
- Pharmacokinetics of ALD518 in plasma; time frame: Measured at Baseline, Week 2, Week 4, Last Day of RT and Week 4 Post-RT
- Impact of ALD518 on Patient-reported Outcomes as measured by the OMDQ, FACT-HN, and FACIT-fatigue scale; time frame: Begins at baseline and is measured at least weekly though WEek 4 Post-RT
- C-reactive protein serum concentrations; time frame: Measured at intervals from Screening visit through Week 4 Post-RT

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Canada
  •   Germany
  •   Italy
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Locations of Recruitment

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Recruitment

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  •   2011/07/31
  •   96
  •   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

- Have recently diagnosed (< than 6 months prior to screening visit date),
pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx,
hypopharynx or larynx that will be treated with CRT as first-line treatment; subjects
with a history of surgical management (approximately 4-6 weeks before RT with
sufficient time for post-surgical healing) are eligible

- Have a plan to receive a continuous course of conventional external beam irradiation
delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0
to 2.2 Gy, with a cumulative radiation dose between 55 and 72 Gy.

- Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to
100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2) or a standard
carboplatin regimen administered weekly (100 mg/m2)

- Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

- CRP < 80 mg/L

- Have adequate hematopoietic, hepatic, and renal function at the screening visit

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Exclusion Criteria

- Tumor of the lips, sinuses, salivary glands, nasopharynx or unknown primary tumor

- Metastatic disease (M1) Stage IV C

- Any prior history of head and neck cancer

- Prior radiation to the head and neck

- Have had a major surgical procedure, other than for HNC, or significant traumatic
injury within 4 weeks prior to the initiation of RT; or anticipation of need for a
major surgical procedure during the clinical trial

- Active infectious disease, excluding oral candidiasis

- Have OM at the screening visit

- Have a history of hypersensitivity to monoclonal antibody

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Alder Biopharmaceuticals, Inc.
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    • Alder Biopharmaceuticals, Inc.
    • Jeffrey Smith, MD FRCP 
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    • Alder Biopharmaceuticals, Inc.
    • Jeffrey Smith, MD FRCP 
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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 complete, follow-up continuing
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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 .
  •   126
  •   2013/12/01
* This entry means the parameter is not applicable or has not been set.