Study of Intravenous RXDX-107 in Patients With Solid Tumors



Status:Terminated
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/20/2018
Start Date:September 2015
End Date:September 2016

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A Phase 1/1b, Multicenter, Open-Label Study of Intravenous RXDX-107 in Adult Patients With Locally Advanced or Metastatic Solid Cancer

This is an open-label, Phase I/Ib, dose escalation study of intravenous RXDX-107 administered
to subjects with advanced solid tumors. The study is designed to explore the safety, maximum
tolerated dose (MTD), pharmacokinetics, pharmacodynamics, and preliminary clinical activity
of RXDX-107 and to define a recommended Phase 2 dose (RP2D)


Inclusion Criteria:

1. Confirmed relapsed or refractory locally advanced or metastatic solid cancer for whom
no standard therapy is considered appropriate, or for whom standard therapy is
considered intolerable.

2. >18 years of age.

3. ECOG performance status of 0 or 1.

4. Life expectancy of at least 3 months.

5. Received the last dose of previous treatment / therapy before Day 1 of cycle 1:

- 28 days for cytotoxic chemotherapy, immunotherapy, whole brain radiotherapy,
anticonvulsive therapy, stereotactic radiosurgery and major surgery

- 42 days for nitrosureas, mitomycin C, and liposomal anthracycline

- 14 days for non-cytotoxic cancer therapies and radiotherapy

6. Recovered from all toxic effects (excluding alopecia) of any prior anti-cancer therapy
to Grade ≤ 1 or to the baseline laboratory values.

7. Adequate organ function and baseline laboratory values

8. Women of childbearing potential must have a negative serum pregnancy

Phase 1b: Patient must have measurable disease

Exclusion Criteria:

1. Receiving other experimental therapy

2. Known symptomatic brain mets or leptomeningeal involvement

3. Myocardial infarction in the previous 12 weeks. Active ischemia or any other
uncontrolled cardiac condition such as angina pectoris, significant cardiac arrhythmia
requiring therapy, uncontrolled hypertension, or CHF.

4. Another concurrent illness which would preclude study conduct and assessment,
uncontrolled: medical condition, active infection, risk of bleeding, diabetes
mellitus, or pulmonary disease, or alcoholic liver disease, or primary biliary
cirrhosis.

5. Malignancy within 3 years or active disease requiring treatment other than the target
cancer. The exceptions are prostate cancer (Gleason grade < 6 with normalized PSA
levels), treated in situ cervical, breast carcinoma, squamous or basal cell skin
cancer.

6. Any condition that may compromise the ability to give written informed consent or to
comply with the study protocol.
We found this trial at
3
sites
Baltimore, Maryland 21287
Principal Investigator: Nilo Azad, MD
Phone: 410-502-5140
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Principal Investigator: Todd Bauer, MD
Phone: 877-691-7274
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Sarasota, Florida 34232
Principal Investigator: Manish Patel, MD
Phone: 877-691-7274
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Sarasota, FL
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