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Phase II Study of 852A Administered Subcutaneously in Patients With Metastatic Refractory Breast, Ovarian, Endometrial and Cervical Cancers


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Ovarian Cancer, Endometrial Cancer, Cervical Cancer

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Trial Information

Phase II Study of 852A Administered Subcutaneously in Patients With Metastatic Refractory Breast, Ovarian, Endometrial and Cervical Cancers


852A will be administered as a subcutaneous injection (SC) 2 times per week for 12 weeks
(24 doses) with provisions for dose escalation or reduction based on tolerability.


Inclusion Criteria:



- Adequate performance status:

- Breast - Karnofsky score > 50;

- Ovarian, endometrial or cervical - Gynecologic Oncology Group (GOG) performance
score ≤2

- If female and of childbearing potential, are willing to use adequate contraception
(hormonal, barrier method, abstinence) prior to study entry and for the duration of
study participation.

- Normal organ function within 14 days of study entry

- Diagnosis of one of the following malignancies:

- Metastatic breast cancer (BR)

- Metastatic ovarian cancer (OV)

- Metastatic endometrial cancer (EM)

- Metastatic cervical cancer (CX)

Breast Cancer

Inclusion Criteria:



- Measurable metastatic disease (>1cm) in at least one site other than bone-only

- Progression on or failure to respond to at least one previous chemotherapy regimen
for metastatic disease

- Progression on prior therapy with a hormonal agent if estrogen receptor or
progesterone receptor positive, and/or with trastuzumab if HER2-neu positive. If
patient has progressed through hormone or trastuzumab therapy only, must have
received one chemotherapy regimen.

Ovarian Cancer

Inclusion Criteria:



- Measurable metastatic disease as defined by Response Evaluation Criteria in Solid
Tumors (RECIST)

- Primary tumor must have been diagnosed histologically as either epithelial ovarian
cancer, fallopian tube cancer, or primary peritoneal cancer (not borderline or low
malignant potential epithelial carcinoma).

- Subjects must have failed at least two previous chemotherapy regimens. Paclitaxel
must have been a component of one or both regimens and cisplatin or carboplatin must
have been a component of one or both regimens.

Endometrial Cancer

Inclusion Criteria:



- Measurable metastatic disease

- Histologically proven recurrent or persistent endometrial cancer that is not amenable
to curative treatment with surgery and/or radiation therapy AND has failed 2 previous
treatment regimens

Cervical Cancer

Inclusion Criteria:



- Measurable metastatic disease

- Histologically proven recurrent or persistent squamous cell carcinoma, adenosquamous
carcinoma, or adenocarcinoma of the cervix that is not amenable to curative treatment
with surgery and/or radiation therapy AND has failed 2 previous treatment regimens.

Exclusion Criteria:

- Had/have the following prior/concurrent therapy:

- Systemic corticosteroids (oral or injectable) within 7 days of first dose of
852A (topical or inhaled steroids are allowed)

- Investigational drugs/agents within 14 days of first dose of 852A

- Immunosuppressive therapy, including cytotoxic agents within 14 days of first
dose of 852A (nitrosoureas within 30 days of first dose)

- Drugs known to induce QT interval prolongation and/or induce Torsades de pointes
unless best available drug required to treat life-threatening conditions

- Radiotherapy within 3 weeks of the first dose of 852A

- Hematopoietic cell transplantation within 4 weeks of first dose of 852A

- Evidence of active infection within 3 days of first dose of 852A

- Active fungal infection or pulmonary infiltrates (prior treated disease stable
for 2 weeks is allowable)

- Cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled
by medication

- History of, or clinical evidence of, a condition which, in the opinion of the
investigator, could confound the results of the study or put the subject at
undue risk

- Uncontrolled intercurrent or chronic illness

- Active autoimmune disease requiring immunosuppressive therapy within 30 days

- Active coagulation disorder not controlled with medication

- Pregnant or lactating

- Concurrent malignancy (if in remission, at least 5 years disease free) except
for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell
carcinomas that have been adequately treated

- Any history of brain metastases or any other active central nervous system (CNS)
disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A.

Outcome Time Frame:

after 12 weeks (24 doses of 852A)

Safety Issue:

No

Principal Investigator

Sarah Cooley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

06US03IMP-852A

NCT ID:

NCT00319748

Start Date:

April 2006

Completion Date:

December 2008

Related Keywords:

  • Breast Cancer
  • Ovarian Cancer
  • Endometrial Cancer
  • Cervical Cancer
  • Breast
  • Ovarian
  • Endometrial
  • Cervical
  • Metastatic
  • 852A
  • IRM
  • Oncology
  • Metastatic Cervical Cancer
  • Metastatic Ovarian Cancer
  • Metastatic Breast Cancer
  • Metastatic Endometrial Cancer
  • Breast Neoplasms
  • Endometrial Neoplasms
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Adenoma

Name

Location

Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota  55455