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NRG-GY008

Trial

Clinical Trial Title

Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer

Trial Status

Closed to Enrollment

Start Date

March 6, 2017

Trial Type

Cancer - Adult Oncology

Specific Condition

Uterine Cancer

Description

This phase II trial studies how well copanlisib works in treating patients with endometrial cancer that has not decreased or disappeared, and the cancer may still be in the body despite treatment (persistent) or has come back (recurrent). Copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

  • Have recurrent or persistent endometrial cancer (endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, mixed epithelial carcinoma or adenocarcinoma not otherwise specified [NOS])
  • Female age  ≥ 18
  • Performance Status [ECOG/Karnofsky] of 0, 1 or 2
  • Have a somatic PIK3CA gene mutation
  • Have at least one "target lesion" to be used to assess response on this protocol
  • Have had at least one prior chemotherapeutic regimen for management of endometrial carcinoma
  • Have recovered from effects of recent surgery, radiotherapy, or chemotherapy

Ineligibility Criteria

  • Have had prior therapy with any PI3K/AKT/mTor pathway inhibitor
  • Have the following histologies: mucinous, squamous, sarcomas, carcinosarcomas, clear cell
  • Severe, active co-morbidity
  • History of, or current autoimmune disease
  • HIV infection
  • Hepatitis B (HBV) or hepatitis C (HCV)
  • Previous or concurrent history of malignancies within 5 years prior to study treatment except for curatively treated: Cervical carcinoma in situ, Non-melanoma skin cancer, Superficial bladder cancer (Ta [non-invasive tumor], Tis [carcinoma in situ] and T1 [tumor invades lamina propria])

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Notes

https://clinicaltrials.gov/ct2/show/NCT02728258

Study status is:
Suspended (Scheduled Interim Monitoring) - The study has stopped early but may start again.

Principal Investigator Name

Colleen McCormick, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, January 27, 2021 12:56:53 PM