An Open-Label, Multicenter, Phase 1b/2 Study of Rebastinib (DCC-2036) in Combination With Paclitaxel to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced or Metastatic Solid Tumors

Trial ID # NCT03601897
Phase Ib/II
Drug Class Angiogenesis Inhibitors: Multi-targeted RTK
Drug Name Rebastinib
Alternate Drug Names multitargeted tyrosine kinase inhibitor DCC-2036
Drugs in Trial Paclitaxel, Rebastinib
Eligible Participant

Platinum resistant or refractory ovarian cancer

Patients Enrolled

38, median 4 prior therapies (2-7); 21% BRCA MUT, 87% w/ prior bevacizumab, 68% w/ prior PARP inhibitor

Therapy Setting

Recurrence

Study Design

Open-Label, Non-randomized

Endpoints

ORR, DCR, DoR, PFS, evaluated per RECIST

Efficacy

ORR: 38% (1CR, 12PR, n=34)
DCR (4 months): 76% (1CR, 12PR, 18SD, n=34)
DoR: 5.5 months
PFS: 9.1 months

Clinically Significant Adverse Events

Serious AE: reversible muscular weakness (n=1), urinary tract infection (n=1)
Grade 3-4 AE: overall (38%)

Conclusion

Rebastinib+paclitaxel is well tolerated and shows encouraging anti-tumor activity in heavily pretreated patients with ovarian cancer

Reference

Janku F et al. Phase 1b/2 study of rebastinib (DCC-2036) in combination with paclitaxel: Preliminary safety, efficacy, pharmacokinetics and pharmacodynamics in patients with advanced or metastatic solid tumors. AACR-NCI-EORTC (2019) abstr B055
https://mct.aacrjournals.org/content/18/12_Supplement/B055

Hamilton EP et al. A phase Ib/II study of rebastinib and paclitaxel in advanced/metastatic platinum-resistant ovarian cancer. Annals of Oncology (2021) 32 (suppl_5): abstract 728P
https://oncologypro.esmo.org/meeting-resources/esmo-congress-2021/a-phase-ib-ii-study-of-rebastinib-and-paclitaxel-in-advanced-metastatic-platinum-resistant-ovarian-cancer

Hamilton EP et al. Poster
https://www.clearityfoundation.org/wp-content/uploads/2021/10/Rebastinibtaxol-poster-2021.pdf

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