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--CLOSED-- A Phase I dose escalation study evaluating the safety and efficacy of RV1001, an isoform selective PI3K inhibitor, in dogs with lymphoma -- CLOSED--
The primary objectives of this study is to identify the maximum tolerated dose of RV1001 in dogs with lymphoma and leukemia and to evaluate the ability of RV1001 to induce responses in dogs with lymphoma or leukemia that have not yet been treated.
PI3 kinase (PI3K) is a protein that is involved in cell signaling. It has several isoforms and each has a different role in different cell types. It has been shown that for lymphomas and leukemias, PI3K isoforms gamma and delta are particularly important in maintaining tumor growth. Blocking the ability of PI3K to function induces death of lymphoma cells in the tissue culture dish, and also in mouse models. Based on these data, novel inhibitors of PI3K have been developed that are given orally. Clinical trials of such agents are currently underway in humans and the data look promising for response therapy in both lymphoma and leukemia. Rhizen Inc has developed a novel PI3K inhibitor termed RV1001 that is given orally.
We have demonstrated that RV1001 blocks PI3K signaling in lymphoma cells isolated from the lymph nodes of dogs with lymphoma. When given to healthy dogs, RV1001 is well tolerated with mild weight loss associated with a mild decrease in appetite. Therefore, RV1001 has potential to be active in dogs with lymphoma.
- Dogs diagnosed with histologically or cytologically confirmed B or T cell lymphoma or chronic lymphocytic leukemia are eligible to be enrolled. The patient may have failed standard therapy or there may be no other known effective antineoplastic therapeutic options, or the owner may elect to enter the patient in lieu of standard therapy.
- Dogs must be at least 1 year of age.
- Adequate organ function as indicated by standard laboratory tests (complete blood count, serum biochemistry profile, urinalysis).
- ANC≥1000/μL and platelet count ≥ 100,000/μL
- Liver: Total bilirubin ≤ 1.5X the institutional upper limit of normal (ULN), ALT ≤ 3X ULN
- Renal: Serum creatinine ≤ 1.5X ULN
- ECOG performance score of 0-1
- Dogs must have an estimated life expectancy of at least 28 days.
- Prior chemotherapy or radiation must be completed 2 weeks prior to study entry and the patient must have recovered from the acute toxicities of these treatments.
- Informed written consent must be obtained
- The owner must be able to orally administer drug according to designated schedule.
- Pregnant or lactating dogs
- Evidence of brain metastasis
- Dogs with uncontrolled autoimmune hemolytic anemia (AIHA) or immune mediated thrombocytopenia (ITP) are not eligible.
- Concurrent use of complementary or alternative medicines that in the opinion of the principal investigators would confound the interpretation of toxicities and/or antitumor activity of the study drug.
- Dogs with significant cardiovascular disease.
- Less than 2 weeks from a major surgical procedure.
- Any serious systemic disorder incompatible with the study (at the discretion of the principal investigators).
- Use of any other investigational drug within 1 week of study entry.
Your dog will receive RV1001 given orally once per day. Your dog will return weekly for the first 4 weeks, then every other week thereafter if your dog has experienced a complete response, partial response, or stable disease following treatment. Analysis for tumor response will be performed by direct tumor measurement or through the use of x-rays. Standard bloodwork will be performed at each visit. Additional tests to be performed include blood draws to measure blood levels of RV1001 on Day 0 at 0,2,4,6,8 hrs after drug administration and before drug administration on Days 7,14,21 and 28. Also, fine needle aspirations of the lymph nodes to determine how well RV1001 is affecting the ability of PI3K to signal in the lymphoma cells will be obtained on Days 0,7 and 21 of the study.
Once deemed eligible, the clinical trial will cover all costs associated with screening prior to study entry, all treatments, and treatment of any side effects associated with the RV1001 administration.
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