Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003621

Trial Description

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Title

A Multicenter, Randomized, Double-blind Study of Dacarbazine With or Without Genasense in Chemotherapy-naive Subjects With Advanced Melanoma and Low LDH (The AGENDA Trial)

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Trial Acronym

AGENDA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study is being performed to prospectively determine whether dacarbazine plus Genasense
is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with
advanced melanoma and low baseline LDH (LDH less than or equal to 0.8 times the upper limit
of normal). LDH is a biomarker strongly associated with improved outcomes in a recent trial
of dacarbazine plus Genasense.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00003621
  •   2012/04/18
  •   2007/08/14
  •   no
  •   [---]*
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Secondary IDs

  •   NCT00518895  (ClinicalTrials.gov)
  •   AGENDA  (Genta Incorporated)
  •   GM307 
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Health Condition or Problem studied

  •   Melanoma
  •   C43 -  Malignant melanoma of skin
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Interventions/Observational Groups

  •   Drug: dacarbazine plus Genasense
  •   Drug: dacarbazine plus placebo
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Characteristics

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

- Progression-free survival and overall survival; time frame: Every 42 days from date of randomization during protocol therapy

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Secondary Outcome

- Response rate, durable response rate, duration of response, safety; time frame: Response and progression every 42 days from date of randomization during protocol therapy

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Countries of Recruitment

  •   United States
  •   Australia
  •   Austria
  •   Canada
  •   Czech Republic
  •   France
  •   Germany
  •   Italy
  •   Poland
  •   Spain
  •   Switzerland
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2007/07/31
  •   300
  •   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

- Histologically confirmed diagnosis of melanoma

- Progressive disease that is not surgically resectable, or metastatic Stage IV

- Low-normal LDH, defined as ≤ 0.8 times the upper limit of normal

- No prior chemotherapy

- Measurable disease

- ECOG performance status ≤ 1

- At least 4 weeks and recovery from effects of major prior surgery or other therapy,
including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy

- Prior immunotherapy allowed

- Adequate organ function

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Exclusion Criteria

- Prior cytotoxic chemotherapy, including regional perfusion, or prior Genasense
treatment

- Primary ocular or mucosal melanoma

- Bone-only metastatic disease

- History or presence of brain metastasis or leptomeningeal disease

- Significant medical disease other than cancer

- Organ allograft

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Addresses

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    • Genta Incorporated
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    •   [---]*
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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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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/05/01
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Trial Publications, Results and other Documents

  •   [---]*
  •   Bedikian AY, Agarwala SS, Gilles E, Itri L, Kay R, Garbe C. The AGENDA Study: A randomized, double-blind study of Genasense plus dacarbazine (DTIC) in chemotherapy-naïve subjects with advanced melanoma and low LDH. Pigment Cell Res. 2007;20:538 [Abstract T-26].
  •   Bedikian AY, Millward M, Pehamberger H, Conry R, Gore M, Trefzer U, Pavlick AC, DeConti R, Hersh EM, Hersey P, Kirkwood JM, Haluska FG; Oblimersen Melanoma Study Group. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol. 2006 Oct 10;24(29):4738-45. Epub 2006 Sep 11.; 16966688
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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 .
  •   8
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.