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Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]

Phase 3
18 Years
Not Enrolling
Ovarian Neoplasms

Thank you

Trial Information

Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]

Inclusion Criteria:

- Are a woman 18 years of age or older

- Have histologically or cytologically confirmed epithelial cancer of the
ovary or fallopian tube, or primary peritoneal cancer

- Have platinum refractory or resistant cancer

- Measurable disease according to radiographic RECIST criteria with documented tumor

Exclusion Criteria:

- Had treatment with first-line chemotherapy other than platinum-based regimens
(carboplatin or cisplatin)

- Have clinically significant cardiac disease

- Have any sign of intestinal obstruction interfering with nutrition at the time of
study entry

- Are pregnant or lactating

- Had prior treatment with liposomal doxorubicin for ovarian cancer

- Had prior treatment with TLK286

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Study Objectives

Outcome Description:

To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin

Outcome Time Frame:

Every 8 Weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2004

Completion Date:

July 2008

Related Keywords:

  • Ovarian Neoplasms
  • Ovary
  • Neoplasms
  • Ovarian Neoplasms



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