Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer

Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00350948

Acronym

ASSIST-5

Enrollment

244

Registered

2006-07-11

Start date

2006-05-31

Completion date

2008-12-31

Last updated

2013-11-27

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

Conditions

Ovarian Neoplasms

Keywords

Ovary

Brief summary

The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer that is refractory or resistant to platinum chemotherapy.

Detailed description

This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with liposomal doxorubicin (Doxil/Caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. Patients will be randomly assigned to receive either TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) or active control liposomal doxorubicin (Doxil/Caelyx).

Interventions

DRUGTelcyta

Day 1 of 28 day Cycle.

DRUGLiposomal Doxorubicin

Day 1 of 28 Day Cycle. 50 mg/m2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Are a woman 18 years of age or older * Have histologically or cytologically confirmed epithelial cancer or primary peritoneal cancer * Have platinum refractory or resistant cancer * Measurable disease according to radiographic RECIST criteria progression

Exclusion criteria

* Had treatment with first-line chemotherapy other than a platinum-containing regimen * Have clinically significant cardiac disease * Have any sign of intestinal obstruction interfering with nutrition * Are pregnant or lactating * Had prior treatment with liposomal doxorubicin * Had prior treatment with Telcyta

Design outcomes

Primary

Measure	Time frame
To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin	Once 244 planned pts. received at least 2 cycles of study treatment(s)

Secondary

Measure	Time frame
To evaluate and compare the safety profile of each treatment arm	Any patient who received 1 dose of study treatment(s) will be evaluable for safety.

Countries

Belgium, Brazil, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026