Study of Anti-HB-EGF Antibody KHK2866 in Subjects With Advanced Solid Tumors and Ovarian Cancer

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a two-part, Phase 1, open-label, multicenter, dose escalation study of KHK2866 as monotherapy in patients with advanced solid tumors, and in combination with chemotherapy in subjects platinum-sensitive and platinum-resistant ovarian cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyowa Hakko Kirin Pharma, Inc.
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Antibodies, Monoclonal; Carboplatin; Doxorubicin; Gemcitabine; Immunoglobulins; Liposomal doxorubicin; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically or cytologically documented, measurable or non-measurable, advanced primary or recurrent solid tumor (Phase 1a only) which is unresponsive to standard therapy or for which there is no standard therapy available.

• Histologically or cytologically documented ovarian, primary peritoneal, or fallopian tube cancer.

• The subject has objective radiographic disease progression and either unmeasurable or measurable disease during or following the last treatment regimen, or serum cancer antigen-125 (CA-125) greater than 2X the upper limit of normal ([ULN] >70 U/mL

• Life expectancy >3 months.

• Performance status < 3 at study entry.

• Age > 18 years.

• Normal left ventricular ejection fraction.

• Recovered from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other therapies for cancer

• Preserved hepatic, renal, and hematopoetic organ function.

• Male and female subjects must use medically accepted contraception.

Exclusion Criteria:

• Ovarian malignancy of low malignant potential.

• Received anti-cancer chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to the first dose of KHK2866 (6 weeks for nitrosourea or mitomycin chemotherapy).

• received Mabs or had major surgery within 4 weeks of the first dose of KHK2866.

• Requires administration of a prohibited medication or treatment including:

prophylactic use of erythroid and/or granulocyte colony stimulating factors; concurrent anti-cancer treatment; biologic response modifiers for any condition

• Brain metastases, leptomeningeal or primary brain neoplasm, even if treated.

• Previously untreated or uncontrolled epidural metastasis

• Cerebrovascular accident, Transient ischemic attack; symptomatic head trauma, or seizures or any kind within 6 months

• Dementia, or other disorders of mentation or difficulty speaking or difficulty with comprehension.

• Suspected impending bowel obstruction

• The subject is pregnant,or is lactating.

• Significant uncontrolled intercurrent illness

• Known HIV infection or AIDS-related illness.

• Known active hepatitis B or C or other active liver disease.

• Psychiatric illness, disability or social situation that would compromise the subject's safety, ability to provide consent, or limit his/her compliance with study requirements.

• Experienced a unmanageable hypersensitivity reactions to Mabs or other therapeutic proteins.

• History of second primary cancer, with the exception of: a) curatively resected non-melanomatous skin cancer; b) curatively treated cervical carcinoma in-situ; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 2 years.

• Additional exclusion criteria for subjects proposed for enrollment into the Phase 1b portion:

• History of hypersensitivity or infusion reaction to any of the proposed chemotherapy arm's agents that could not be controlled with pre-medication and/or infusion rate adjustment;

• Prior treatment with KHK2866;

• History of Grade ≥ 3 non-hematologic or Grade 4 hematologic toxicity attributable to any of the proposed chemotherapy arm's agents

• For subjects proposed to receive treatment with KHK2866 plus PLD: prior total cumulative exposure to doxorubicin must be ≤ 240 mg/m2.

• Subjects with a known history of interstitial lung disease or pulmonary fibrosis. Subjects must have pulse oximetry >88% on room air at rest, and a DLco of >49% if there is no evidence of lung metastasis.