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A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 When Given on a Q14 Day or a Q21 Day Schedule in Patients With Metastatic or Locally Advanced Platinum-Resistant Ovarian Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Tumor, Ovarian Cancer

Thank you

Trial Information

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 When Given on a Q14 Day or a Q21 Day Schedule in Patients With Metastatic or Locally Advanced Platinum-Resistant Ovarian Cancer


Inclusion Criteria:



1. Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer,
primary peritoneal cancer or fallopian tube cancer

2. Inoperable metastatic or locally advanced ovarian cancer

3. Platinum-resistant ovarian cancer defined as progression by RECIST within 6 months of
last dose of most recent platinum drug

4. Platinum-resistant patients who have progressed after receiving PLD
(Doxil/Caelyx)therapy in a platinum-resistant setting or who otherwise unable to
receive PLD therapy.

5. Diseases must be measurable as defined by RECIST in at least 1 lesion not previously
irradiated.

6. ECOG performance score of 0 or 1.

7. Adequate organ and bone marrow functions at Screening.

Exclusion Criteria:

1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) and have not recovered to NCI-CTCAE grade 1 toxicity
prior to Day 1 of Cycle 1

2. Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle 1 or
minor surgery within 2 weeks prior to Day 1 of Cycle 1

3. Patients who have received CYP3A4 inducers or inhibitors.

4. Patients who have received any treatment with a camptothecin derivative (eg.
irinotecan, topotecan, SN38 investigational agents, etc.).

5. Patients with CNS metastases.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Robert Medve, MD

Investigator Role:

Study Director

Investigator Affiliation:

Nektar Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

08-PIR-04

NCT ID:

NCT00806156

Start Date:

October 2008

Completion Date:

Related Keywords:

  • Tumor
  • Ovarian Cancer
  • Ovarian Neoplasms

Name

Location

University of IowaIowa City, Iowa  52242
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Gynecologic Oncology AssociatesNewport Beach, California  92663
USC Norris Comprehensive Cancer CenterLos Angeles, California  90089
Piedmont Hematology Oncology AssociatesWinston Salem, North Carolina  27103
University of Virginia Health SystemCharlottesville, Virginia  22903
Sarah Cannon Research InstituteNashville, Tennessee  37203
Beaver Medical GroupHighland, California  92346
Pharma ResourceEast Providence, Rhode Island  02915
Palm Beach Cancer CenterWest Palm Beach, Florida  33401
Surgical Gynecological AssociatesOklahoma City, Oklahoma  73142