Brief Title
PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer
Official Title
A Double-blind, Placebo-controlled, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of Maintenance Therapy With PankoMab-GEX™ After Chemotherapy in Patients With Recurrent Epithelial Ovarian Carcinoma
Brief Summary
Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced
ovarian, fallopian tube or primary peritoneal cancer.
Detailed Description
The study is to evaluate the efficacy of PankoMab-GEX vs Placebo in maintaining response
after 2nd to 4th line of chemotherapy in patients with epithelial ovarian or fallopian tube
or primary peritoneal cancer. Patients must have responded to platinum based chemotherapy in
a previous line, while the response to the most recent Pt-based chemotherapy must not have
lasted more than 12 months. In addition the response between most recent 2 lines of
chemotherapy prior start of study medication must not have lasted more than 12 months.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression free survival
Secondary Outcome
To assess the safety and tolerability of maintenance therapy with single-agent PankoMab-GEX™ compared to placebo in patients with metastatic or recurrent ovarian or fallopian tube carcinoma or primary peritoneal carcinoma.
Condition
Ovarian Epithelial Cancer Recurrent
Intervention
Gatipotuzumab
Study Arms / Comparison Groups
Gatipotuzumab
Description: 1700mg, i.v., q3w
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
216
Start Date
September 2013
Completion Date
November 2017
Primary Completion Date
June 16, 2017
Eligibility Criteria
Inclusion Criteria:
1. Female patients ≥18 years of age.
2. Histologically-confirmed, TA-MUC1 positive, recurrent epithelial ovarian or
fallopian-tube cancer or primary peritoneal cancer with high-grade (grade 2 or 3)
serous features or a serous component.
3. Availability of tumor tissue samples (slices or block) for immune-histological
confirmation of TA-MUC1 status (tissue samples may also be stored for other further
specified biomarker assessments).
4. Patients should have received at least 2 lines but not more than 5 lines of
chemotherapy prior to start of maintenance treatment.
5. Documented response to or stable disease following the most recent line of
chemotherapy (any regimen and duration in accordance with local or international
guidelines or within independent ethics committee [IEC] approved studies) and received
last dose of said chemotherapy ≤6 weeks prior to randomization (response to prior
chemotherapy is defined as a partial/complete response according to radiological
response criteria and/or a confirmed decline in tumor marker CA125 ≥50% from the
pretreatment value ≥2 × the upper limit of normal [ULN]; stable disease is defined as
stable disease according to radiological response criteria with a confirmed lack of
increase in tumor marker CA125 from the pretreatment value for patients who have a
pretreatment value ≥2 × ULN and no clinical progression). CA125 prior to randomization
must be below ULN or CA125 levels must not increase >15% within a time frame >7 days
if above ULN.
6. Progression-free interval of ≤12 months immediately preceding the chemotherapy to
which the patient has just responded.
7. Sensitive or resistant to the most recent platinum-based chemotherapy preceding the
chemotherapy to which the patient has just responded (sensitive is thereby defined as
a recurrence of disease >6 to ≤12 months after end of platinum-based chemotherapy and
resistant is defined as a recurrence of disease ≤6 months after the end of
platinum-based chemotherapy).
8. ECOG performance status ≤1.
9. Recovered from all chemotherapy-related toxicities to grade 1 or grade 0 according to
the NCI CTCAE version 4.0, with the exception of alopecia (any grade) and peripheral
neuropathy (≤grade 2).
10. Adequate bone marrow and hepatic function at Screening:
- Hemoglobin ≥9 g/dL
- White blood cell count ≥3.0 × 109/L
- Absolute neutrophil count ≥1.5 × 109/L
- Platelet count ≥100 × 109/L
- Aspartate aminotransferase and alanine aminotransferase <3 × ULN (<5 × ULN in
case of liver metastases)
- Bilirubin <1.5 × ULN (<3 × ULN in case of liver metastases)
- Creatinine <1.5 × ULN.
11. Any patient with childbearing potential (i.e., not surgically sterile or
postmenopausal for >1 year) must use highly effective contraceptives with a Pearl
index <1% according to the Note for guidance on non-clinical safety studies for the
conduct of human clinical trials and marketing authorization for pharmaceuticals
(CPMP/ICH/286/95) of the European Medicines Agency (EMA) (Note: although pregnancy is
unlikely to occur in this patient population, any patient with childbearing potential
will be withdrawn from the study in the event of pregnancy).
12. Life expectancy >3 months.
13. Ability and willingness to give written informed consent. -
Exclusion Criteria:
1. Refractory to platinum-based chemotherapy (defined as remained progressive or became
progressive under any previous platinum-based regimen).
2. Progression-free interval of >12 months after the most recent antecedent
platinum-based chemotherapy regimen.
3. Concomitant anti-tumor therapy or immunotherapy.
4. Treatment with monoclonal antibodies or investigational agents ≤30 days before
randomization (Note: prior anti-MUC1 therapy is not permitted at any time).
5. Limited-field radiotherapy ≤30 days before randomization (Note: extensive prior
radiotherapy during or following the last line of chemotherapy is not permitted;
radiotherapy prior to the last line of chemotherapy is permitted).
6. Prior allergic reaction to a monoclonal antibody, grade 3 IRR or any grade 4 reaction
to a monoclonal antibody.
7. Known sensitivity to any component of the test product.
8. Contraindication to the premedications used in this study (paracetamol/acetaminophen,
H1 and/or H2 receptor antagonists, and steroids).
9. Clinical evidence of brain metastasis or leptomeningeal involvement.
10. Patients with second primary cancer, except: adequately treated non-melanoma skin
cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ
(DCIS), stage 1 grade 1 endometrial carcinoma, or other solid tumors including
lymphomas (without bone marrow involvement) curatively treated with no evidence of
disease for ≥ 5 years.
11. Primary or secondary immune deficiency.
12. Clinically active infections >grade 2 using NCI CTCAE v 4.0.
13. Active hepatitis B or C or infection with human immunodeficiency virus (HIV).
14. Myocardial infarction within 6 months prior to Screening.
15. Symptomatic congestive heart failure (New York Heart Association grade 3 or 4),
unstable angina pectoris within 6 months prior to Screening, significant cardiac
arrhythmia or history of stroke or transient ischemic attack within 1 year prior to
Screening.
16. Prior or planned major surgery within 30 days prior to randomization and/or incomplete
recovery from prior surgery.
17. Concomitant use of systemic steroids, except for inhaled, topical or nasal application
within 30 days prior to randomization (Note: steroids used for premedication are
permitted).
18. Active drug or alcohol abuse.
19. Any uncontrolled medical condition that may put the patient at high risk during
treatment with an investigational drug, including unstable diabetes mellitus, vena
cava syndrome, or chronic symptomatic respiratory disease.
20. Pregnancy or lactation.
21. Legal incompetence, limited legal competence, or detainment in an institution for
official or legal reasons.
22. Receipt of any other investigational medicinal product within the last 30 days before
randomization or any previous PankoMab-GEXTM administration.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jonathan Ledermann, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01899599
Organization ID
GEXMab25201
Secondary IDs
2013-000931-28
Responsible Party
Sponsor
Study Sponsor
Glycotope GmbH
Study Sponsor
Jonathan Ledermann, MD, Principal Investigator, UCL Cancer Institute, 90 Tottenham Court Road, London W1T 4TJ, UK
Verification Date
July 2017