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

Phase 1-2a Dose-Ranging Study of TLK286 in Combination With Doxil in Platinum Refractory or Resistant Ovarian Cancer

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00052065

Enrollment

Registered

2003-01-23

Start date

2003-02-28

Completion date

2006-03-31

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

Brief summary

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.

Interventions

DRUGTLK286

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Countries

United States

Outcome results

None listed

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