Clinical Trials

Rebastinib (DCC-2036) has been evaluated in several Phase 1 and Phase 1/2 clinical trials sponsored by Deciphera Pharmaceuticals and Montefiore Medical Center to assess its safety, tolerability, and pharmacokinetics. These trials investigated rebastinib as monotherapy and in combination regimens with chemotherapies—including paclitaxel, carboplatin, or eribulin—for advanced solid tumors, HER2-negative metastatic breast cancer, and T315I-mutated Philadelphia chromosome-positive chronic myeloid leukemia. Across this clinical portfolio, trial recruitment statuses are documented as either completed or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03601897 TERMINATED
Locally Advanced or Metastatic Solid Tumor
Deciphera Pharmaceuticals, LLC
 2018-10-25 PHASE1; PHASE2
NCT03717415 TERMINATED
Locally Advanced or Metastatic Solid Tumor
Deciphera Pharmaceuticals, LLC
 2019-01-02 PHASE1; PHASE2
NCT02824575 TERMINATED
Breast Cancer; Breast Adenocarcinoma; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Recurrent Breast Carcinoma; Stage IV Breast Cancer
Montefiore Medical Center
 2016-07 PHASE1
NCT03717415 Completed
Locally Advanced or Metastatic Solid Tumor
Deciphera Pharmaceuticals LLC
 2019-01-02 Phase 1|Phase 2
NCT03601897 Completed
Locally Advanced or Metastatic Solid Tumor
Deciphera Pharmaceuticals LLC
 2018-10-25 Phase 1|Phase 2
NCT00827138 COMPLETED
Chronic Myeloid Leukemia
Deciphera Pharmaceuticals, LLC
 2009-03 PHASE1

(data from https://clinicaltrials.gov, updated on 2024-12-27)

Check the Rebastinib (DCC-2036) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rebastinib functions as a conformational switch control inhibitor that targets both unphosphorylated and phosphorylated ABL1 kinase—including the T315I resistance mutation—while additionally suppressing related tyrosine kinases such as TIE2, FLT3, KDR, and SRC family members. By stabilizing the inactive kinase conformation and interrupting downstream oncogenic signaling pathways, the compound suppresses cell proliferation and survival, providing a functional rationale for inhibiting tumor growth in TKI-resistant chronic myeloid leukemia, advanced solid tumors, and metastatic breast cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.