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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer

NCTNCT00345540 (opens ClinicalTrials.gov in a new tab)Other idNOV002- IS21 -OC
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
15 participants (actual)
Sponsor
Cellectar Biosciences, Inc. · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jul 2006
Primary completion
May 2008
Completion
Jun 2008
First posted
28 Jun 2006 (estimated)
Last update posted
10 Mar 2015 (estimated)
Conditions
Ovarian Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200720082009
  1. Ph 2

    Efficacy of NOV-002 in Combination With Carboplatin in Chemotherapy-resistant Ovarian Cancer

    NCT00345540

    Jul 2006 to Jun 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this trial is to determine the tumor response rate of NOV-002 plus carboplatin in a cohort of women with platinum resistant cancer of ovarian origin.

Interventions

  • NOV-002Drug
  • CarboplatinDrug

Arms1

  • Experimental

    NOV-002 plus Carboplatin

    NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Response Rate

    Time frame · At treatment completion (8 weeks) and monthly until disease progression

Secondary outcomes(2)

  1. Safety of NOV-002 and Carboplatin

    Time frame · Duration of trial and through 30-day follow-up period after final treatment

  2. Progression Free Survival (PFS)

    Time frame · From time of treatment start to time of disease progression

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· At treatment completion (8 weeks) and monthly until disease progression

Response Rate

GroupValue (Participants)
NOV-002 Plus Carboplatin0
Secondary and other outcome results(2)
Secondary outcomeNumber· Duration of trial and through 30-day follow-up period after final treatment

Safety of NOV-002 and Carboplatin

GroupValue (Adverse Events)
NOV-002 Plus Carboplatin0
Secondary outcomeMean· From time of treatment start to time of disease progression

Progression Free Survival (PFS)

GroupValue (Weeks)
NOV-002 Plus Carboplatin19.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
NOV-002 Plus CarboplatinNOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.–9 / 1515 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube cancer * ECOG 0-1 * Platinum resistant or refractory disease defined as progressive disease within 6 months of completing or while receiving their last platinum containing regimen * Measurable disease Exclusion Criteria: * History of other malignancies within 2 years except for adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, incidental stage I endometrial cancer, basal or squamous cell skin cancer * Major surgery within 2 weeks of study entry * History of anaphylactic shock with prior platinum chemotherapy * Known history of central nervous system (CNS) metastases unless subject has had treatment with surgery or radiation therapy and is neurologically stable * Treatment with more than 3 lines of chemotherapy * Chronic use of systemic corticosteroids

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