TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer

Phase 3 Randomized Study of TLK286 (Telcyta) Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-1 (Assessment of Survival In Solid Tumors-1)]

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00057720

Enrollment

440

Registered

2003-04-08

Start date

2003-06-30

Completion date

2006-12-31

Last updated

2011-07-25

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 study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations.

Interventions

DRUGTLK286 HCl for injection

DRUGtopotecan hydrochloride for injection

DRUGdoxorubicin HCl liposome injection

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

include: * Considered platinum refractory or resistant according to standard criteria * Progressed during or following completion of one second-line treatment with Doxil/Caelyx or Hycamtin * Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer * Measurable disease according to RECIST criteria with documented tumor progression

Exclusion criteria

include: * Treatment with second-line chemotherapy other than Doxil/Caelyx or Hycamtin * History of whole pelvis radiation therapy within 12 months of enrollment * Clinically significant cardiac disease * Evidence of gross hematuria at the time of study entry * Any signs of intestinal obstruction interfering with nutrition at the time of study entry * Pregnant or lactating women

Countries

Argentina, Belgium, Brazil, Chile, Czechia, Germany, Hungary, Ireland, Netherlands, South Africa, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026