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Clinical Trials

Date: 2014-07-23

Type of information: Initiation of the trial

phase: 1

Announcement: initiation of the trial

Company: PharmaMar (Spain)

Product: Aplidin® (plitidepsin) in combination with bortezomib and dexamethasone

Action mechanism:

Aplidin® (plitidepsin) is an antitumour agent of marine origin, originally isolated from the marine tunicate Aplidium albicans, and currently obtained by chemical synthesis. This marine-derived cyclodepsipeptide is PharmaMar\'s second most advanced compound. It is currently in phase II clinical trials for solid and haematological malignant neoplasias like T cell lymphoma and in phase III clinical trials for multiple myeloma. Aplidin® has been designated an orphan drug by the European Commission (EC) and the FDA for multiple myeloma (MM).

Disease:

relapsed and/or refractory multiple myeloma

Therapeutic area: Cancer - Oncology - Rare diseases

Country: France, Spain

Trial details:

Latest news:

* On July 23, 2014, Grupo Zeltia, announced that its oncology subsidiary, PharmaMar SA, has initiated of a Phase I clinical trial with Aplidin® (plitidepsin) in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma. The primary endpoint of this trial is to determine the recommended dose of Aplidin® in combination with bortezomib and dexamethasone and to evaluate the efficacy of the combination in patients with multiple myeloma. The trial will be conducted in 6 centres in Spain and France and will recruit 30 patients. Once the trial appropriate dose is determined, an expansion cohort is planned in order to assess the efficacy of Aplidin® for this indication in early stages of treatment. This trial is part of the company’s strategy for the development of Aplidin® as an earlier treatment option for patients with multiple myeloma. The compound is also currently being evaluated in an ongoing Phase III trial for patients with multiple myeloma after the third line of treatment.

Is general: Yes