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Phase 1 Study of Anti-HB-EGF Monoclonal Antibody KHK2866 as Monotherapy in Subjects With Advanced Solid Tumors and in Combination With Chemotherapy in Ovarian Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms, Primary Peritoneal Neoplasm

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Trial Information

Phase 1 Study of Anti-HB-EGF Monoclonal Antibody KHK2866 as Monotherapy in Subjects With Advanced Solid Tumors and in Combination With Chemotherapy in Ovarian Cancer


During Phase 1a, groups of eligible patients with advanced solid tumors will receive KHK2866
as monotherapy in escalating doses. The Phase 1b portion will enroll patients with ovarian
cancer who will receive KHK2866 in combination with one of three chemotherapy regimens
(Arms): gemcitabine+carboplatin (platinum-sensitive, weekly paclitaxel (platinum-resistant),
or pegylated liposomal doxorubicin (platinum-resistant). Escalating doses of the
combination of KHK2866 and the chemotherapy regimen will given to two groups of subjects per
Arm. The goal of the study is to learn about the side effects of KHK2866 alone or given in
combination with chemotherapy. All subjects will receive study therapy for up to 6 cycles
(up to 12 cycles for subjects assigned to PLD [Arm 3 of Phase 1b]), or until disease
progression, the development of severe side effects, noncompliance or withdrawal of consent
by the subject, or other removal criteria whichever comes first.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Description:

The safety of KHK2866 will be determined by reported adverse events (AEs), changes in physical examinations, vital sign measurements, electrocardiograms (ECGs), clinical laboratory evaluations, and treatment discontinuation due to toxicity.

Outcome Time Frame:

at least 60 days, and up to 6 months

Safety Issue:

Yes

Principal Investigator

Bruce A Silver, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Kyowa Hakko Kirin Pharma, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

2866-US-001

NCT ID:

NCT01279291

Start Date:

January 2011

Completion Date:

November 2012

Related Keywords:

  • Neoplasms
  • Ovarian Neoplasms
  • Fallopian Tube Neoplasms
  • Primary Peritoneal Neoplasm
  • advanced solid tumor
  • Ovarian cancer
  • Primary peritoneal cancer
  • Fallopian tube cancer
  • Neoplasms
  • Fallopian Tube Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Oncology ConsultantsHouston, Texas  77024
Cancer Therapy and Research CenterSan Antonio, Texas  78229
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Dana Farber Cancer InstituteBoston, Massachusetts  02115
USC Norris Comprehensive Cancer CenterLos Angeles, California  90089
Cedar Sinai-Samuel Oschin Comprehensive Cancer InstituteLos Angeles, California  90048