Overview
Study of Anti-HB-EGF Antibody KHK2866 in Subjects With Advanced Solid Tumors and Ovarian Cancer
Status:
Terminated
Terminated
Trial end date:
2012-11-01
2012-11-01
Target enrollment:
0
0
Participant gender:
All
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 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Kyowa Hakko Kirin Pharma, Inc.Treatments:
Albumin-Bound PaclitaxelAntibodies
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.