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

A phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) in patients with advanced solid tumours.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000171617

Enrollment

Registered

2014-02-11

Start date

2014-03-12

Completion date

2016-01-11

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study is evaluating the safety, tolerability and pharmacokinetics of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) in patients with advanced solid tumours. Who is it for? You may be eligible to join this study if you are aged over 18 years, have a histologically or cytologically confirmed advanced or metastatic cancer for which no standard or curative therapy exists, a life expectancy greater than 12 weeks, and your disease is measurable or evaluable by the Response Evaluation Criteria In Solid Tumours (RECIST). Trial details: Participants in this study will be administered DEP(TM) Docetaxel (DTX-SPL8783) via intravenous infusion in escalating doses once every 3 weeks. The number of doses and dosage amounts administered to participants are dependent on any toxicities occurring at each dose level. The starting dose is 10mg/m2, increased by 1.4 – 2 times at each dose level. Treatment will be continued until tumour progression, unacceptable toxicity or withdrawal from the study based on investigator discretion or patient decision.

Interventions

DEP(TM) Docetaxel (DTX-SPL8783) / Escalating doses by intravenous infusion, single dose once every cycle (cycle length of 3 weeks). Number of doses (i.e., cycles) and dosage amounts will depend on any toxicities occurring at each dose level. Starting dose of 10mg/m2, increased by 1.4 to 2 times at each dose level. Treatment will be continued until tumour progression, unacceptable toxicity or withdrawal from the study based on investigator discretion or patient decision.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients with histologically or cytologically confirmed advanced or metastatic cancer for which no standard or curative therapy exists; life expectancy of greater than 12 weeks; measurable or evaluable disease by RECIST.

Exclusion criteria

Allergy to docetaxel or other components of study therapy or compounds of similar chemical composition; uncontrolled intercurrent illness; participation in a study of an investigational agent within 30 days prior to first study therapy.

Outcome results