CT-2106 for the Second Line Treatment of Ovarian Cancer

Phase II Open Label Study of CT-2106 as a Single Agent in Patients With Advanced Metastatic Ovarian Cancer Who Have Failed One Prior Platinum and Taxane Based Regimen

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00291837

Enrollment

Registered

2006-02-15

Start date

2004-11-30

Completion date

2007-12-31

Last updated

2010-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

ovarian, CT-2106

Brief summary

The purpose of this sudy is to determine the response rate of CT-2106 in patients with advanced ovarian cancer who have failed one prior platinum and taxane based regimen.

Interventions

DRUGCT-2106

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

* Patients with advanced ovarian carcinoma, who have failed one prior platinum and taxane containing regimen * Only one prior chemotherapy containing either cisplatin or carboplatin plus taxanes administered concomitantly * At least one measurable lesion according to RECIST * ECOG performance status 0 or 1 * at least 18 years old * Adequate haematological function * Adequate renal and hepatic functions * Normal coagulation parameters

Exclusion criteria

* Platinum-sensitive patients (Group 2) who responded (CR or PR) to a 1st line therapy and subsequently progressed or relapsed after a treatment-free interval of \> 12 months * Pregnant or lactating patients * Prior treatment with camptothecins * Presence or history of CNS metastasis or carcinomatous leptomeningitis; * Current active infection per investigator assessment; * Unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis; * Current history of chronic diarrhea \>= grade 1 (CTCAE version 3); * Surgery or radiotherapy ≤ 4 weeks before first study treatment. In case of cytoreductive surgery for the progression of the disease, ≤ 2 weeks before the 1st study treatment are allowed; * Other uncontrolled, serious illness or medical condition, as determined by the investigator; * Concomitant (or within 4 weeks before inclusion) administration of any other experimental drug under investigation; * Concurrent treatment with any other anti-cancer therapy; * Known HIV positivity or AIDS-related illness; * Patients who cannot be regularly followed up for psychological, social, familial or geographic reasons.

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
toxicity	—
response duration	—
time to progression	—
survival	—

Countries

France, Italy, United Kingdom

Outcome results

None listed

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