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NeoplasmsPhase 1NCT01279291

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

A Phase 1 study testing KHK2866, Gemcitabine and Carboplatin and paclitaxel in people with Neoplasms and Ovarian Neoplasms, run by Kyowa Kirin Co., Ltd. at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
KHK2866, Gemcitabine and Carboplatin and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
7 sitesUnited States
Study dates
Jan 2011to Nov 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Oncology Consultants

    Houston, Texas, 77030

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Cedar Sinai-Samuel Oschin Comprehensive Cancer Institute

    Los Angeles, California, 90048

  • Cancer Therapy and Research Center

    San Antonio, Texas, 78229

  • Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
KHK2866, Gemcitabine and Carboplatin, paclitaxel, pegylated liposomal doxorubicin
Keywords
advanced solid tumor, Ovarian cancer, Primary peritoneal cancer, Fallopian tube cancer
Medical subject headings
Neoplasms, Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KHK2866Biological

    Potentially therapeutic monoclonal antibody for the treatment of advanced cancer and ovarian cancer.

  • Gemcitabine and CarboplatinDrug

    Also called Gemzar, Paraplatin

    Combination chemotherapy with KHK2866 to treat advanced platinum-sensitive ovarian cancer. Gemcitabine dose 1000 mg/m2, Carboplatin dose AUC=4

  • paclitaxelDrug

    Also called Taxol

    Combination chemotherapy with KHK2866 to treat advanced platinum-resistant ovarian cancer. Paclitaxel will be administered weekly at a dose of 80 mg/m2.

  • pegylated liposomal doxorubicinDrug

    Also called Doxil

    Combination chemotherapy with KHK2866 to treat advanced platinum-resistant ovarian cancer. PLD will be administered weekly at a dose of 40 mg/m2.

Study groups in NCT01279291
Study groupRoleWhat they receive
KHK2866 as monotherapyExperimentalGroups of subjects will receive a weekly infusions of KHK2866 as treatment for advanced cancer. If there no severe side effects, the dose will be increased for future subjects. A total of four groups are anticipated. Once an acceptable dose is determined an additional seven subjects will be treated at that dose.
Receives: Biological: KHK2866
KHK2866, gemcitabine+carboplatinExperimentalOpen to subjects with ovarian, fallopian tube, or primary peritoneal cancer only. One group of subjects will receive one dose below the maximum tolerated dose of KHK2866 identified in Phase 1a along with gemcitabine and carboplatin. The dose of KHK2866 will be increased to the MTD for the next group if no severe side effects are noted. Once an acceptable dose is determined an additional seven subjects will be treated at that dose.
Receives: Biological: KHK2866; Drug: Gemcitabine and Carboplatin
KHK2866, weekly paclitaxelExperimentalOpen to subjects with ovarian, fallopian tube, or primary peritoneal cancer only. One group of subjects will receive one dose below the maximum tolerated dose of KHK2866 identified in Phase 1a along with weekly paclitaxel (80 mg/m2). The dose of KHK2866 will be increased to the MTD for the next group if no severe side effects are noted. Once an acceptable dose is determined an additional seven subjects will be treated at that dose.
Receives: Biological: KHK2866; Drug: paclitaxel
KHK2866, pegylated liposomal doxorubicinExperimentalOpen to subjects with ovarian, fallopian tube, or primary peritoneal cancer only. One group of subjects will receive one dose below the maximum tolerated dose of KHK2866 identified in Phase 1a along with monthly PLD (40 mg/m2). The dose of KHK2866 will be increased to the MTD for the next group if no severe side effects are noted. Once an acceptable dose is determined an additional seven subjects will be treated at that dose.
Receives: Biological: KHK2866; Drug: pegylated liposomal doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: at least 60 days, and up to 6 months

Secondary outcomes (4)

  1. To determine the Cmax, Tmax, AUC and half life of KHK2866 when administered i.v. as monotherapy

    Participants will have serial blood samples taken to determine the PK profile of the study drug.

    Measured: at least 28 days and up to 6 months

  2. To evaluate the changes in serum HB-EGf in participants administered KHK2866

    Participants will have serial blood samples taken to develop the PD profile.

    Measured: at least 60 days, and up to 6 months

  3. To screen for the development of antibodies against KHK2866 (immunogenicity).

    Participants will have serial blood samples to check for the development of anti-KHK2866 antibodies.

    Measured: at least 60 days and up to 6 months

  4. To describe any anti-tumor activity observed when KHK2866 is administered i.v. as monotherapy, or in combination with chemotherapy.

    Measured: at least 60 days and up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2011 (estimated)
  2. Study startJan 2011
  3. Primary completionNov 2012
  4. Study completionNov 2012

Why it stopped: The study was stopped due to the inability to determine an acceptable dose with the potential for further study

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01279291
Sponsor's protocol ID
2866-US-001
Status last verified
Apr 2024
First submitted
11 Jan 2011
Last updated
26 Apr 2024
Results posted
No
Data monitoring committee
No

Publications

  • Sarantopoulos J, Mita MM, Birrer MJ, Cranmer LD, Campos LT, Zhang X, Bristow P, Kaito H, Strout V, Camacho LH. Phase 1 Study of Monotherapy with KHK2866, an Anti-Heparin-Binding Epidermal Growth Factor-Like Growth Factor Monoclonal Antibody, in Patients with Advanced Cancer. Target Oncol. 2016 Jun;11(3):317-27. doi: 10.1007/s11523-015-0394-5.

    PubMed 26507836

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KHK2866, Gemcitabine and Carboplatin and paclitaxel in people with Neoplasms and Ovarian Neoplasms, run by Kyowa Kirin Co., Ltd. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The study was stopped due to the inability to determine an acceptable dose with the potential for further study). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: at least 60 days, and up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01279291, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.

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