Study investigating new drug, IMC-1121B, in patients with recurring or persistant cancer of the ovary, fallopian tube or lining of the abdominal cavity. Both patient and doctor will know the treatment administered.

Phase 1

• Conditions: Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma; MedDRA version: 14.1 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-006717-17-GB
• Lead Sponsor: ImClone LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-13
• Study Completion: 2015-08-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. The patient has recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via a pathology report.

2. The patient has at least one unidimensionally-measurable target lesion (= 2 cm with conventional techniques, or = 1 cm by spiral computed tomography [CT] or magnetic resonance imaging [MRI]), as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Tumors within a previously irradiated field will be designated as nontarget” lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.

3. The patient has recovered to Grade = 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v3.0) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies for ovarian cancer, with the exception of alopecia or peripheral neuropathy (which must have resolved to Grade = 2). Any other prior therapy directed at the malignant tumor must be discontinued at least three weeks prior to the first dose of study medication, or hormonal therapy discontinued at least one week prior to the first dose of study medication. Continuation of hormone replacement therapy is permitted.

4. The patient has completed at least one platinum-based chemotherapeutic regimen for management of primary disease, and must have at least one of the following: a platinum-free interval of < 12 months after the final dose of primary platinum-based therapy, progression during platinum-based therapy, or persistent disease after platinum-based therapy.

5. The patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1 at study entry.

6. The patient has adequate hematological functions (absolute neutrophil count [ANC] = 1200 cells/µL, hemoglobin = 9 g/dL, and platelets = 100,000 cells/µL).

7. The patient has adequate hepatic function (bilirubin = 1.5 times the upper limit of normal [ULN]; aspartate transaminase [AST] and/or alanine transaminase [ALT] = 3.0 times ULN, or = 5.0 times ULN if the transaminase elevation is due to liver metastases).

8. The patient has adequate renal function (serum creatinine = 1.5 x ULN or creatinine clearance [measured or calculated] = 60 mL/min).

9. The patient’s urinary protein is = 1+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicated = 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study.

10. The patient has adequate coagulation function, as defined by international normalized ratio (INR) = 1.5 and a partial thromboplastin time (PTT) = 1.5 X ULN if not receiving anticoagulation therapy. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin, and if on warfarin must have therapeutic INR and have no active bleeding (defined as within 14 days of first dose of study medication) or pathological condition that carries a high risk o

Exclusion Criteria

1. The patient has a concurrent active malignancy, other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm. A patient with previous history of malignancy is eligible provided that she has been disease-free for > 3 years.
2. The patient has received a noncytotoxic regimen (usually called targeted therapy such as bevacizumab) for recurrent or persistent disease. (Patients may have received a noncytotoxic regimen as primary treatment.)
3. The patient has received radiotherapy for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within 3 weeks (21 days) prior to the first dose of study medication.
4. The patient has received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last 3 years. (Prior radiation for localized cancer [eg, of the breast, head and neck, or skin] is permitted, provided that it was completed > 3 years prior to the first dose of study medication, and the patient remains free of recurrent or metastatic disease.)
5. The patient has received prior chemotherapy for any abdominal or pelvic tumor, other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer < 3 years prior to the first dose of study medication. Prior adjuvant chemotherapy for localized breast cancer is permitted, provided that it was completed >3 years prior to the first dose of study medication, and that the patient remains free of recurrent or metastatic disease.
6. The patient has undergone major abdominal surgery within 4 weeks (28 days) prior to first dose of study medication.
7. The patient has a suspected impending bowel obstruction, based on clinical or radiographic criteria.
8. The patient has received any hormonal therapy directed at the malignant tumor discontinued therapy within 1 week (7 days) prior to first dose of study medication.
9. The patient has received any other prior therapy directed at the malignant tumor, including immunologic agents, within 3 weeks (21 days) prior to first dose of study medication.
10. The patient has received previous treatment with IMC-1121B.
11. The patient has participated in clinical trials of experimental agents within 4 weeks (28 days) prior to first dose of study medication.
12. The patient has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders.
13. The patient has an ongoing or active infection requiring systemic antibiotics, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, myocardial infarction < 6 months, Grade = 2 peripheral vascular disease, poorly controlled hypertension despite standard medical management poorly controlled thrombotic or hemorrhagic disorder, psychiatric illness or social situations that would limit compliance with study requirements, or any other serious uncontrolled medical disorders in the opinion of the investigator.
14. The patient has any history of brain metastases or leptomeningeal disease. Screening for CNS involvement for testing asymptomatic patients is not required.
15. The patient has known human immunodeficiency vir

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified