MK-8628 Solid Tumor Trial

Phase 1

Conditions: T Midline CarcinomaNon-Small Cell Lung CancerTriple-Negative Breast CancerCastration-Resistant Prostate Cancer
MedDRA version: 18.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.1Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2015-005488-18-ES

Lead Sponsor: Oncoethix GmbH, a wholly owned subsidiary of Merck Sharp & Dohme Corp.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 42

Inclusion Criteria

In order to be eligible for participation in this trial, the subject must:
1.Have signed informed consent/assent prior to initiation of any study-specific procedures and treatment. For study subjects who are legal minors, the parent or legal guardian must also sign the consent/assent form. The subject may also provide consent/assent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical research.
2.Have histologically or cytologically confirmed diagnosis of one of the following advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective, intolerable or inacceptable for the subject:
a)NUT midline carcinoma (NMC)(ectopic expression of NUT protein as determined by IHC and/or detection of BRD-NUT gene translocation as determined by FISH)
b)Non-small cell lung cancer (NSCLC): all comers without gene rearrangement or mutational restrictions
c)Triple negative breast cancer (TNBC) defined according to ASCO recommendations
d)Castration-resistant prostate cancer (CRPC)
3.Have at least one measurable lesion as per RECIST version 1.1., except for CRPC subjects who may be enrolled with objective evidence of disease as per Prostate Cancer Clinical Trials Working Group (PCWG2) criteria.
4.For NSCLC, TNBC and CRPC subjects, be age > or = 18 years at the time of informed consent; for NMC subjects, be age > or = 16 years at the time of informed consent.
5.Have a life expectancy > or = 3 months.
6.Have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ? 1.
7.Demonstrate adequate organ function (adequate bone marrow reserve, renal and liver function)
8.Have an interval of > or = 3 weeks since chemotherapy (> or = 6 weeks for nitrosoureas or mitomycin C), immunotherapy, hormone therapy or any other anticancer therapy (including investigational) or surgical intervention resection, or > or = 3 half-lives for monoclonal antibodies, or > or = 5 half-lives for other non-cytotoxic agents (whichever is longer).
9.CRPC subjects must maintain ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue, antagonist or orchiectomy providing serum testosterone is < 50 ng/dL (<1.7 nmol/L).
10.Subjects receiving bisphosphonate or denosumab therapy must be on stable doses for at least 4 weeks before initiating study treatment
11.Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
12.Female subjects of childbearing potential should be willing to use an adequate method of contraception as outlined in section 5.7.3? Contraception, for the course of the study through 60 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
13.Male subjects of childbearing potential must agree to use an adequate method of contraception as outlined in Section 5.7.3 ? Contraception, starting with the first dose of trial treatment through 60 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) yes
F.1.2.1 Nu

Exclusion Criteria

The subject must be excluded from participating in the trial if the subject:
1.Has inability to swallow oral medications or presence of a gastrointestinal disorder (e.g. malabsorption) deemed to jeopardize intestinal absorption of MK-8628.
2.Has persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ? grade 2 National Cancer Institute (NCI)-CTCAE v. 4.0 is accepted.
3.Has known primary CNS malignancy or symptomatic or untreated CNS metastases.
4.Has a history of prior or concomitant malignancies (other than excised non-melanoma skin cancer or cured in situ cervical carcinoma) within 3 years of signing informed consent.
5.Has other serious illness or medical condition, such as active infection, unresolved bowel obstruction, psychiatric disorders, or cerebrovascular accident (within 1 year of study entry).
6.Has known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
7.Has known active Hepatitis B (e.g. hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C (e.g. hepatitis C viral [HCV] RNA [qualitative] is detected).
8.Has any of the following cardiac-related conditions:
a.Congestive heart failure or angina pectoris (except if medically controlled)
b.Previous history of myocardial infarction (within 1 year of study entry)
c.Uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg, and/or diastolic blood pressure > 90 mmHg, and not adequately managed by anti-hypertensive medication)
d.Uncontrolled arrhythmias
9.Has participated in another clinical trial or treatment with any investigational drug (excluding anticancer treatments) within 30 days prior to study entry.
10.Has other concomitant anticancer treatment, except the use of anti-androgens in CRPC subjects.
11.Has concomitant therapy with strong CYP3A4 inhibitors or inducers.
12.Is currently using anticoagulants (e.g. warfarin, heparin) at therapeutic levels within 7 days prior to the first dose of MK-8628. Low-dose (prophylactic) low molecular weight heparin (LMWH) is permitted.
13.Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject?s participation for the full duration of the trial.
14.Is pregnant or breast-feeding.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials