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TLK286 in Combination With Paraplatin (Carboplatin) in Recurrent 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

NCT00051948
TLK286.2018

Details and patient eligibility

About

This is a dose-ranging, open label, Phase 1-2a study of TLK286 in combination with Paraplatin (carboplatin) in patients with recurrent 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, or primary peritoneal cancer
  • Recurrent ovarian cancer or persistent disease following primary treatment
  • At least one, but no more than four, prior chemotherapy regimens (all platinum-containing counted as one)
  • At least 18 years of age

Exclusion Criteria

  • Pregnant or lactating women
  • 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 patient has been disease-free for at least 2 years
  • Known leptomeningeal metastases or carcinomatous meningitis
  • 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

6

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Data sourced from clinicaltrials.gov

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