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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-

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Trial Conditions
  • Ovarian Neoplasms
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Female

Eligibility

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

Gender: Female
Trial Interventions
Drug
  • TLK286 HCl for injection
  • topotecan hydrochloride for injection
  • doxorubicin HCl liposome injection
Other Information

Sponsor: Telik
Phase: Phase 3
Trial ID: NCT00057720
Volunteers:  Not Accepting Healthy Volunteers

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