Know Cancer

or
forgot password

An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies


N/A
18 Years
N/A
Open (Enrolling)
Both
Malignant Solid Tumour, Breast Cancer, Ovarian Cancer, Colorectal Cancer

Thank you

Trial Information

An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies

Inclusion Criteria


Inclusion:

Subjects must fulfill Inclusion Criteria to be eligible for study entry:

1. Previous treatment with NKTR-102 with demonstrated clinical benefit

2. ECOG performance score of 0 or 1

3. Adequate bone marrow and organ function at screening

4. Receive the first dose of NKTR-102 int he extension study within 12 weeks of
receiving their last dose of the NKTR-102 in the original protocol

Exclusion:

Subjects meeting any of the Exclusion Criteria are ineligible for enrollment:

1. Received intervening anti-cancer therapy between last dose int he original protocol
and administration of the first dose in the extension study

2. Had major surgery within 4 weeks prior to Day 1 of Cycle 1 or minor surgery within 2
weeks prior to Day 1 Cycle 1.

3. Received cytochrome P450 #4A(CYP3A4)inducers or inhibitors

4. Receiving anti-cancer biologic agents with 28 days of Day 1 Cycle 1

5. Have unresolved or irreversible NKTR-102 related ongoing AE occurring during the
original protocol

6. Have diarrhea.

Type of Study:

Expanded Access

Study Design:

N/A

Principal Investigator

Robert Medve, MD

Investigator Role:

Study Director

Investigator Affiliation:

Nektar Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

11-PIR-09

NCT ID:

NCT01457118

Start Date:

October 2011

Completion Date:

September 2015

Related Keywords:

  • Malignant Solid Tumour
  • Breast Cancer
  • Ovarian Cancer
  • Colorectal Cancer
  • Open Label multicenter extension study advanced solid tumors
  • Breast Neoplasms
  • Colorectal Neoplasms
  • Ovarian Neoplasms
  • Neoplasms

Name

Location

USC Norris Comprehensive Cancer CenterLos Angeles, California  90089