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TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

T

Telik

Status and phase

Completed
Phase 2
Phase 1

Conditions

Ovarian Neoplasms

Treatments

Drug: TLK286

Study type

Interventional

Funder types

Industry

Identifiers

NCT00052065
TLK286.2011

Details and patient eligibility

About

This is a dose-ranging, open-label, Phase 1-2a study of TLK286 in combination with Doxil in patients with platinum refractory or resistant ovarian cancer.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube cancer or primary peritoneal cancer
  • Recurrent epithelial ovarian cancer or persistent disease following primary treatment
  • At least one, but no more than four, prior platinum-containing chemotherapy regimens
  • At least one prior taxane-containing regimen

Exclusion Criteria

  • A history of prior malignancy except for adequately treated carcinoma in situ of the uterine cervix, basal cell or squamous cell skin cancer, or other cancer for which the patient has been disease-free for 2 years
  • Known leptomeningeal metastases or carcinomatous meningitis
  • Have received prior Doxil or other liposomal doxorubicin
  • Having received whole pelvis radiation therapy

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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