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|NCT03058289 : A Phase 1/2 Safety Study of Intratumorally Dosed INT230-6|
|Phase||Phase 1/Phase 2|
|Ages||Min: 18 Years Max: N/A|
1. Men and Women > 18 years of age with Eastern Cooperative Oncology Group (ECOG)
performance status < 2;
2a. Eligibility: U.S. Sites
Includes subjects with loco-regional disease that have relapsed/recurred within 6 months of
chemo-radiation and who have no standard of care.
Includes patients (subjects) with metastatic disease having injections into only
superficial lesions that have failed (includes progression, relapse or intolerance) or not
be a candidate for approved therapies. Note, patients (subjects) that have approved
therapies available, which might confer clinical benefit, may be enrolled as long as the
physician properly explains the nature of the treatment, and obtains consent ".
Includes patients (subjects) with metastatic disease having at least one deep tumor
injection who have failed (includes progression, relapse or intolerance) all approved lines
of therapy prior to enrollment unless they are not an appropriate candidate for a
particular approved therapy or no approved therapy exists.
Note: There is no limit on the number of prior therapies that a patient (subject) may have
received prior to enrollment in any cohort.
2b. Eligibility: Canadian Sites
Subjects with advanced or metastatic solid tumors that have disease progression after
treatment with approved, available therapies (in site's country) for the cancer type or for
whom available therapies have limited benefit and the subject refuses the available
therapy. Includes subjects with locoregional disease that have relapsed/recurred within 6
months of chemo-radiation; or who have no standard of care or beneficial options. No limit
on the number of prior treatments;
3. Subjects must have measurable disease by RECIST 1.1 criteria including one target tumor
for injection. Superficial tumors must have one tumor greater than or equal to 1.0 cm, deep
tumors greater than or equal to 1.0 cm (as measured by caliper (for non-injected tumors
only) or image guidance);
4. Subjects must have a minimum of one injectable lesion as determined by the investigator
(for superficial tumors) or radiologist (deep tumors).
5. Prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to
control the cancer: systemic or IT) must have been completed at least 4 weeks prior to
enrollment and all adverse events have either returned to baseline (or resolved to < grade
1); note: subjects who have received prior platinum therapy are eligible irrespective of
6. Prior systemic radiation therapy (either IV, intrahepatic or oral) completed at least 4
weeks prior to study drug administration.
7. Prior focal radiotherapy completed at least 4 weeks prior to study drug administration.
8. Prior major treatment-related surgery completed at least 4 weeks prior to study drug
9. No prior primary or metastatic brain or meningeal tumors unless clinically and
radiographically stable as well as off steroid therapy for at least 2 months;
10a. Life expectancy =8 weeks all (US); 10b. Life expectancy =12 weeks; = 8 weeks
superficial tumors (Canada);
11. Subjects who may become pregnant or who are sexually active with a partner who could
become pregnant are to use an effective form of barrier contraception during the study and
for at least 60 days for female patients and 180 days for male patients after
administration of study drug; and
12. Screening laboratory values must meet the following criteria:
1. White Blood Cell (WBC) =2000/µL (=2 x 10^9/L)
2. Neutrophils =1000/µL (=1 x 10^9/L)
3. Platelets =70x103/µL (= 70 x 10^9/L) (superficial tumor dosing only)
4. Hemoglobin =8 g/dL (=80 g/L) (superficial tumor dosing only)
5. Creatinine within the institution's laboratory upper limit of normal (ULN) or
calculated creatinine clearance >50 ml/min
6. alanine aminotransferase /aspartate aminotransferase (ALT/AST) =2.5 x ULN without, and
= 5 x ULN with hepatic metastases
7. Bilirubin =2 x ULN (except subjects with Gilbert's syndrome, who must have total
bilirubin < 3.0 mg/dL (<52 µmol/L))
8. For patients with planned deep tumor injections: prothrombin time (PT), activated
partial thromboplastin time (aPPT), and international normalized ratio (INR) within
normal limits; Platelet count =100,000/µL; hemoglobin = 9 gm/dL.
13. Additional criteria for cohort D (anti-PD1 combo) will be supplied in an appendix
at a later date.
1. History of severe hypersensitivity reactions to cisplatin or vinblastine or other
products of the same class;
2. Other prior malignancy, except for adequately treated basal or squamous cell skin
cancer or superficial bladder cancer, or any other cancer from which the subject
has been disease-free for at least 5 years;
3. Underlying medical condition that, in the Principal Investigator's opinion, will
make the administration of study drug hazardous or obscure the interpretation of
toxicity determination or adverse events;
4. Concurrent medical condition requiring the use of immunosuppressive medications,
or systemic or topical corticosteroids; systemic or topical corticosteroids must
be discontinued at least 4 weeks prior to enrollment. Inhaled or intranasal
corticosteroids (with minimal systemic absorption may be continued if the subject
is on a stable dose). Non-absorbed intra-articular steroid injections will be
permitted; or use of other investigational drugs (drugs not marketed for any
indication) within 30 days prior to study drug administration. Use of steroids as
prophylactic treatment for subjects with contrast allergies to diagnostic imaging
contrast dyes will be permitted;
5. For deep tumor cohorts, patients who require uninterrupted anticoagulants of any
type, on daily aspirin therapy, or NSAIAs.
6. U.S. ONLY: For all Cohorts, patients who refuse approved therapy for which they
are a suitable candidate are not eligible for enrollment on this trial.
7. Additional criteria for cohort D (anti-PD1 combo) will be supplied in an appendix
at a later date.
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