Current Clinical Trials

  • DEP® docetaxel – Phase 1

  • VivaGel® - Prevention of recurrence in BV – Phase 3

DEP® docetaxel – Phase 1

Status: Recruiting patients

 

Title

A phase 1 study of dendrimer-docetaxel (DEP® docetaxel) in patients with advanced cancer.

 

Overview

The study is evaluating the safety, tolerability and pharmacokinetics of DEP® docetaxel (a docetaxel (DTX)-dendrimer conjugate) in patients with advanced solid tumours.

 

Trial details:

Participants in this study will be administered DEP® docetaxel via intravenous infusion in escalating doses once every 3 weeks.

 

Endpoints

Primary Outcomes:

Determination of the maximum tolerated dose (MTD) as assessed by occurrence of dose limiting toxicities (DLT)

Secondary Outcomes:

General safety and tolerability profile, as determined by adverse events (AE)

Tumour response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria

Pharmacokinetic profile in blood

 

Clinical Trial Identifier

ACTRN12614000171617

 

VivaGel® - Prevention of recurrence in BV – Phase 3

Status: Completed, results reported.

 

Title

Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV)

 

Overview

Two double-blind, phase 3 studies to determine the efficacy of SPL7013 Gel when administered on alternate days for 16 weeks, compared to placebo gel in preventing the recurrence of BV in women with a history of recurrent BV

 

Endpoints

Primary Outcome Measures:

•    Recurrence of BV where a diagnosis of BV is defined as the presence of at least 3 clinical findings.

Secondary Outcome Measures:

•    Time to recurrence of BV according to the primary efficacy endpoint definition

•    Presence of patient-reported BV symptoms.

•    Recurrence of individual Amsel criteria. 

•    Amsel criteria are:

              i) Presence of homogenous vaginal discharge characteristic of BV

              ii) Positive whiff test

              iii) Clue cells representing at least 20% of total epithelial cells

              iv) vaginal fluid pH greater than 4.5

•    Recurrence of BV as determined by presence of a Nugent score of 7-10.

•    Recurrence of BV according to the primary efficacy endpoint definition.

•    Recurrence of BV according to the composite definition of at least 3 clinical findings and a Nugent score of at least 4.

•    Adverse events (AEs)

•    Responses to Quality of Life (QoL) Questionnaires.

 

Clinical Trial Identifier

NCT02236156

NCT02237950

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For more information regarding trial participation email:

clinicaltrials@starpharma.com

 

 

 

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