- |||||||||| ganitumab (AMG479) / Takeda, NantWorks
[VIRTUAL] PNEUMONITIS AFTER WHOLE LUNG IRRADIATION ON CHILDREN'S ONCOLOGY GROUP AEWS1221 (Hall 4) - Aug 26, 2020 - Abstract #SIOP2020SIOP_1198; Of patients with pneumonitis, 4 were female and 5 were randomized to the trial experimental arm and received the study drug ganitumab prior to WLI...Average V20 for patients experiencing pneumonitis exceeded study guidelines. Future efforts are underway to evaluate radiotherapy variables that may impact the risk of pneumonitis including mean lung dose, lung V20 and lung V30, and compare these to patients who did not develop pneumonitis.
- |||||||||| RELAPSED METASTATIC EWING SARCOMA INITIALLY RESPONSIVE TO DINUTUXIMAB IN A PEDIATRIC PATIENT () - Apr 3, 2020 - Abstract #ASPHO2020ASPHO_319;
We present a case of a patient with relapsed Ewing sarcoma whose tumor appears to have responded to Dinutuximab. While this is one patient and we did not have the ability to assess the extent or duration of response, these findings further support the need for clinical trials evaluating Dinutuximab therapy for relapsed Ewing sarcoma.
- |||||||||| conatumumab (AMG 655) / Amgen
Trial completion: Open Label Extension Study of Conatumumab and Ganitumab (AMG 479) (clinicaltrials.gov) - Apr 1, 2020 P2, N=12, Completed, While this is one patient and we did not have the ability to assess the extent or duration of response, these findings further support the need for clinical trials evaluating Dinutuximab therapy for relapsed Ewing sarcoma. Active, not recruiting --> Completed
- |||||||||| Application of Machine Learning to elucidate the biology predicting response in the I SPY 2 neoadjuvant breast cancer trial (Atrium) - Feb 28, 2020 - Abstract #BOP2020BOP_48;
Our study involves 986 patients with pre treatment gene expression and pCR data across 10 treatment arms including inhibitors of HER2: neratinib (N), pertuzumab (P), TDM1/P; AKT (MK 2206; M); IGF1R (ganitumab); HSP90 (ganetespib); PARP/DNA repair (veliparib/carboplatin; VC); ANG 1/2 (AMG386); immune checkpoints (pembrolizumab; Pembro); and a shared control arm (Ctr). Our results suggests that hypothesis driven analysis restricted to assumed mechanisms of action of the experimental agents may be insufficient, and that exploration of possible off target effects may be needed to understand the underlying biology of response or resistance.
- |||||||||| Biomarker, Enrollment change, PARP Biomarker, PD(L)-1 Biomarker: I-SPY 2: I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (clinicaltrials.gov) - Feb 10, 2020
P2, N=4000, Recruiting, Our results suggests that hypothesis driven analysis restricted to assumed mechanisms of action of the experimental agents may be insufficient, and that exploration of possible off target effects may be needed to understand the underlying biology of response or resistance. N=1920 --> 4000
- |||||||||| conatumumab (AMG 655) / Amgen
Trial completion date, Trial primary completion date: Open Label Extension Study of Conatumumab and Ganitumab (AMG 479) (clinicaltrials.gov) - Dec 19, 2019 P2, N=12, Active, not recruiting, Trial primary completion date: Dec 2020 --> Dec 2025 Trial completion date: Nov 2019 --> Mar 2020 | Trial primary completion date: Sep 2019 --> Mar 2020
- |||||||||| Ibrance (palbociclib) / Pfizer, ganitumab (AMG 479) / Takeda, ImmunityBio
Enrollment open: Palbociclib + Ganitumab In Ewing Sarcoma (clinicaltrials.gov) - Nov 28, 2019 P2, N=18, Recruiting, Trial completion date: Nov 2019 --> Mar 2020 | Trial primary completion date: Sep 2019 --> Mar 2020 Not yet recruiting --> Recruiting
- |||||||||| Application of machine learning to elucidate the biology predicting response in the I-SPY 2 neoadjuvant breast cancer trial (Hall 1) - Oct 19, 2019 - Abstract #SABCS2019SABCS_1982;
Our study involves 986 patients with pre-treatment gene expression and pCR data across 10 treatment arms including inhibitors of HER2: neratinib (N), pertuzumab (P), TDM1/P; AKT (MK-2206; M); IGF1R (ganitumab); HSP90 (ganetespib); PARP/DNA repair (veliparib/carboplatin; VC); ANG1/2 (AMG386); immune checkpoints (pembrolizumab; Pembro); and a shared control arm (Ctr). Our results suggests that hypothesis driven analysis restricted to assumed mechanisms of action of the experimental agents may be insufficient, and that exploration of possible off target effects may be needed to understand the underlying biology of response or resistance.
- |||||||||| Ibrance (palbociclib) / Pfizer, ganitumab (AMG 479) / Takeda, ImmunityBio
New P2 trial: Palbociclib + Ganitumab In Ewing Sarcoma (clinicaltrials.gov) - Oct 15, 2019 P2, N=18, Not yet recruiting,
- |||||||||| ganitumab (AMG479) / Takeda, NantWorks, everolimus / Generic mfg., Vectibix (panitumumab) / Amgen, Takeda
Clinical, P1 data, Journal, Combination therapy: A Phase I Trial of the IGF-1R Antibody Ganitumab (AMG 479) in Combination with Everolimus (RAD001) and Panitumumab in Patients with Advanced Cancer. (Pubmed Central) - Sep 22, 2019 This trial evaluated the maximum tolerated dose or recommended phase II dose and safety and tolerability of the ganitumab and everolimus doublet regimen followed by the ganitumab, everolimus, and panitumumab triplet regimen. Although the triplet regimen of ganitumab, everolimus, and panitumumab was associated with unacceptable toxicity, the doublet of ganitumab at 12 mg/kg every 2 weeks and everolimus at five times weekly had an acceptable safety profile and demonstrated notable clinical activity in patients with refractory non-small cell lung cancer and sarcoma.
- |||||||||| ganitumab (AMG 479) / Takeda, ImmunityBio, Vectibix (panitumumab) / Amgen
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: A Trial of AMG 479, Everolimus (RAD001) and Panitumumab in Patients With Advanced Cancer - QUILT-3.007 (clinicaltrials.gov) - Aug 28, 2019 P1, N=43, Completed, Although the triplet regimen of ganitumab, everolimus, and panitumumab was associated with unacceptable toxicity, the doublet of ganitumab at 12 mg/kg every 2 weeks and everolimus at five times weekly had an acceptable safety profile and demonstrated notable clinical activity in patients with refractory non-small cell lung cancer and sarcoma. Active, not recruiting --> Completed | N=100 --> 43 | Trial completion date: Jun 2019 --> Dec 2018 | Trial primary completion date: Jun 2019 --> Dec 2018
- |||||||||| conatumumab (AMG 655) / Amgen
Trial completion date, Trial primary completion date: Open Label Extension Study of Conatumumab and Ganitumab (AMG 479) (clinicaltrials.gov) - Nov 6, 2018 P2, N=12, Active, not recruiting, Trial primary completion date: Oct 2021 --> Jan 2021 Trial completion date: Jan 2019 --> Nov 2019 | Trial primary completion date: Jan 2019 --> Sep 2019
- |||||||||| conatumumab (AMG 655) / Amgen
Trial completion date, Trial primary completion date: Open Label Extension Study of Conatumumab and Ganitumab (AMG 479) (clinicaltrials.gov) - Jul 18, 2018 P2, N=12, Active, not recruiting, Trial primary completion date: Jun 2018 --> Jun 2019 Trial completion date: Jul 2018 --> Jan 2019 | Trial primary completion date: Jul 2018 --> Jan 2019
- |||||||||| ganitumab (AMG479) / Takeda, NantWorks, rilotumumab (AMG 102) / Amgen
Biomarker, Clinical, P1/2 data, Journal, Combination therapy: A Randomized, Placebo-Controlled, Phase 1b/2 Study of Rilotumumab or Ganitumab in Combination With Platinum-Based Chemotherapy as First-Line Treatment for Extensive-Stage Small-Cell Lung Cancer. (Pubmed Central) - Jun 22, 2018 Completed --> Terminated Although the combination of rilotumumab or ganitumab with chemotherapy was tolerable, overall outcomes were not improved in patients with ES-SCLC.
- |||||||||| ganitumab (AMG 479) / Takeda, ImmunityBio, Vectibix (panitumumab) / Amgen
Enrollment closed: A Trial of AMG 479, Everolimus (RAD001) and Panitumumab in Patients With Advanced Cancer - QUILT-3.007 (clinicaltrials.gov) - Feb 12, 2018 P1, N=100, Active, not recruiting, Although the combination of rilotumumab or ganitumab with chemotherapy was tolerable, overall outcomes were not improved in patients with ES-SCLC. Recruiting --> Active, not recruiting
- |||||||||| ganitumab (AMG 479) / Takeda, ImmunityBio
Trial completion, Trial primary completion date, Metastases: AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors (clinicaltrials.gov) - Dec 27, 2017 P2, N=60, Completed, Recruiting --> Active, not recruiting Active, not recruiting --> Completed | Trial primary completion date: Aug 2016 --> Jan 2016
- |||||||||| ganitumab (AMG 479) / Takeda, ImmunityBio
Trial completion, Trial primary completion date, Combination therapy, Metastases: Study of RAD001 + AMG479 for Patients With Advanced Solid Tumors (clinicaltrials.gov) - May 10, 2017 P1, N=27, Completed, Initiation date: Jan 2017 --> Jun 2017 Active, not recruiting --> Completed | Trial primary completion date: May 2020 --> Jan 2015
- |||||||||| Mektovi (binimetinib) / Ono Pharma, Pierre Fabre, Pfizer
Trial termination, Metastases: A Study of MEK162 and AMG 479 in Patients With Selected Solid Tumors (clinicaltrials.gov) - Feb 15, 2017 P2, N=77, Terminated, Trial primary completion date: Jan 2017 --> Jul 2017 Completed --> Terminated; Study was withdrawn due to scientific and business considerations.
- |||||||||| ganitumab (AMG 479) / Takeda, ImmunityBio
Trial primary completion date, Combination therapy, Metastases: Study of RAD001 + AMG479 for Patients With Advanced Solid Tumors (clinicaltrials.gov) - Feb 2, 2017 P1, N=30, Active, not recruiting, Trial primary completion date: Jun 2017 --> Jun 2018 Trial primary completion date: Feb 2014 --> May 2020
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