A Phase 1/2a Dose-Finding Study of PT-112 in Patients With Relapsed or Refractory Multiple Myeloma

Conditions:Blood Cancer, Hematology, Hematology
Therapuetic Areas:Hematology, Oncology
Age Range:18 - Any
Start Date:December 15, 2017
End Date:June 30, 2019
Contact:Tammy Hood

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Study PT-112-102, a multicenter, open-label dose-finding and pharmacokinetic study of PT-112
in patients with relapsed or refractory multiple myeloma.

This is designed as a two-part study. In the first part of the study, cohorts of three
patients (expanded to six patients in the event of a dose-limiting toxicity) will receive
escalating doses of PT-112 until the MTD is reached, based on tolerability observed during
the first 28 days of treatment. In the second part of the study, an expansion cohort of 14
patients will be treated at the recommended dose to confirm the tolerability of treatment and
evaluate evidence of treatment efficacy.

Key Inclusion Criteria:

1. Previously diagnosed with MM requiring treatment based on IMWG diagnostic criteria;

2. Relapsed or refractory MM after adequate exposure to and therapeutic response
(following IMWG response criteria) to at least one line of treatment with one or more
active agents, including alkylating drugs, corticosteroids, immunomodulatory drugs
(IMiD: thalidomide, lenalidomide, pomalidomide), proteasome inhibitors (bortezomib,
cartilzomib), and monoclonal antibodies (daratumumab, elotuzumab, ixazomab);

3. Evaluable MM with at least one of the following: (a) serum monoclonal component ≥ 0.5
g/dL; or (b) Bence Jones (BJ) proteinuria ≥ 200 mg/24h; or (c) measurable plasmacytoma
(not previously irradiated); or (d) involved serum free light chain ≥ 10 mg/dL with an
abnormal free light chain ratio;

4. ECOG Performance Status (PS) 0-2;

5. Life expectancy > 3 months;

6. At least 2 weeks (or 5 half-lives, whichever is longer) wash-out since the end of
previously administered experimental therapy (6 weeks if previous nitrosourea
containing regimen) or 2 weeks for standard-of-care regimens. Concurrent
corticosteroids are allowed provided they are administered at an equivalent prednisone
dose of ≤ 10 mg/day, as prediction or blood products only;

7. Recovery from non-hematologic toxic effects of prior therapy to grade ≤ 1 (except
alopecia) by NCI CTCAE Version 4.03;

8. Adequate bone marrow (BM), renal, hepatic and metabolic function.

Key Exclusion Criteria:

1. Any of the following concomitant diseases/conditions:

- History or presence of myocardial infarction, clinically relevant valvular heart
disease, or congestive heart failure within the last 12 months;

- Unstable cardiac dysrhythmias or persistent prolongation of the corrected QT
interval (QTc) (Fridericia) to >480 msec for males or >500 msec for females,
based on ECG at screening (patients with stable atrial fibrillation on treatment
are allowed provided they do not meet any other cardiac or prohibited drug
exclusion criterion);

- Presence of current angina;

- Active uncontrolled infection;

- Morphological or cytological features of myelodysplasia and/or post-chemotherapy
aplasia on BM assessment;

- Myopathy > grade 2 or any clinical situation that causes significant and
persistent elevation of CPK (>2.5 x ULN in two different determinations performed
one week apart);

- Peripheral neuropathy > grade 1, except for grade 2 without limitations on
instrumental daily life activities;

- POEMS syndrome or active plasma cell leukemia;

- Chronic graft versus host disease (GVHD) or on immunosuppressive therapy for the
control of GVHD;

- History or presence within the last 3 months of Deep Vein Thrombosis (DVT) or a
pulmonary embolism (PE);- Uncontrolled leptomeningeal disease;

- Uncontrolled disease-related metabolic disorder (e.g., hypercalcemia);

- Acute or chronic infections requiring systemic therapy, including, among others:

- active infection requiring systemic therapy;

- history of testing positive to human immunodeficiency virus (HIV) or known
acquired immunodeficiency syndrome;

- hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening
(positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is

- active tuberculosis (history of exposure or history of positive TB test with
presence of clinical symptoms, physical or radiographic finding);

- Any other major illness that, in the Investigator's judgment, may substantially
increase the risk associated with the patient's participation in this study;

2. History of prior malignancy other than those previously treated with a curative intent
more than 5 years ago and without relapse (any tumor) or basal cell skin cancer, in
situ cervical cancer, superficial bladder cancer, or high grade intestinal polyps
treated adequately, regardless of the disease-free interval;

3. Prior irradiation to > 30% of BM reserves (including total body irradiation),
regardless of the washout period;

4. High dose chemotherapy followed by autologous stem cell transplantation within 90 days
prior to initiating study treatment;

5. Bisphosphonate treatment within 7 days prior to initiating study treatment (while on
study, bisphosphonates can be administered only once a month, between Days 18 to 21 of
the 28-day treatment cycle)
We found this trial at
200 First Street SW
Rochester, Minnesota 55905
Principal Investigator: Taxiarchis Kourelis, MD
Phone: 855-776-0015
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
Rochester, MN
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Denver, Colorado 80218
Principal Investigator: Robert Rifkin, MD
Denver, CO
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Jacksonville, Florida 32224
Principal Investigator: Sikander Ailawadhi, MD
Phone: 855-776-0015
Jacksonville, FL
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New Brunswick, New Jersey 08903
Principal Investigator: Dennis Cooper, MD
Phone: 732-235-2465
New Brunswick, NJ
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Dan Vogl, MD
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
Philadelphia, PA
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Phoenix, Arizona 85054
Principal Investigator: Leif Bergsagel, MD
Phone: 855-776-0015
Phoenix, AZ
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San Antonio, Texas 78229
Principal Investigator: Roger Lyons, MD
San Antonio, TX
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