Clinical trial · Interventional
Phase 3 Trial of 90Y-Clivatuzumab Tetraxetan & Gemcitabine vs Placebo & Gemcitabine in Metastatic Pancreatic Cancer
An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan Plus Low-Dose Gemcitabine Versus Placebo Plus Low-Dose Gemcitabine in Patients With Metastatic (Stage IV) Pancreatic Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1)
NCT01956812CI-TRIAL-00053284PANCRIT®-1terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The DSMB conducted an interim analysis on overall survival, which showed that the treatment arm did not demonstrate a sufficient improvement in OS vs. placebo.
Summary
Brief summary (as posted)
The is a double-blind, randomized phase 3 study of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies for metastatic cancer (1 of which was a gemcitabine-containing regimen).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| IMMU-107 | Drug | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A IMMU-107 and gemcitabine
- description
- IMMU-107 and low dose gemcitabine
- interventionNames
- Drug: IMMU-107
- Drug: Gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Arm B Placebo and low dose gemcitabine
- description
- Placebo and low dose gemcitabine
- interventionNames
- Drug: placebo
- Drug: Gemcitabine
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the pancreas * Metastatic disease * Received at least two prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease. * At least one of the prior systemic cytotoxic chemotherapy regimens for unresectable, locally advanced or metastatic disease must have contained gemcitabine and have met the following criteria: * Completed at least one cycle of the treatment * Received gemcitabine administered at a minimum dose of 800 mg/m2 per week in the first cycle of treatment * Progressed while receiving this gemcitabine regimen or within 3 months of completing gemcitabine * Progression was documented, * Preferentially radiologically by tumor growth or new lesions, or by * Clear symptomatic deterioration supported by at least two of the following clinical criteria: ≥ 10% worsening in KPS or ≥ 1 worsening in ECOG; increasing weakness or fatigue; progressive weight loss; new/worsening pain requiring increased pain medication; new/worsening jaundice, nausea, or vomiting; new/worsening ascites or pleural effusions; other physical or laboratory findings consistent with disease progression. * KPS \>/= 70 * Adequate bone marrow function * Adequate hepatic function * Adequate renal function Exclusion Criteria: * CNS metastatic disease * Bulky disease (any single mass \>10 cm). -\>Grade 2 nausea or vomiting, and/or signs of intestinal obstruction. * Prior external beam irradiation to a field that includes more than 30% of the red bone marrow. * Patients with clinically significant severe cardiorespiratory disease. Please consult with the clinical trial site for the full detailed list of specific inclusion/exclusion criteria.
References
Publications (19)
- BACKGROUNDOcean AJ, Pennington KL, Guarino MJ, Sheikh A, Bekaii-Saab T, Serafini AN, Lee D, Sung MW, Gulec SA, Goldsmith SJ, Manzone T, Holt M, O'Neil BH, Hall N, Montero AJ, Kauh J, Gold DV, Horne H, Wegener WA, Goldenberg DM. Fractionated radioimmunotherapy with (90) Y-clivatuzumab tetraxetan and low-dose gemcitabine is active in advanced pancreatic cancer: A phase 1 trial. Cancer. 2012 Nov 15;118(22):5497-506. doi: 10.1002/cncr.27592. Epub 2012 May 8. PMID 22569804
- BACKGROUNDGulec SA, Cohen SJ, Pennington KL, Zuckier LS, Hauke RJ, Horne H, Wegener WA, Teoh N, Gold DV, Sharkey RM, Goldenberg DM. Treatment of advanced pancreatic carcinoma with 90Y-Clivatuzumab Tetraxetan: a phase I single-dose escalation trial. Clin Cancer Res. 2011 Jun 15;17(12):4091-100. doi: 10.1158/1078-0432.CCR-10-2579. Epub 2011 Apr 28. PMID 21527562
- BACKGROUNDSharkey RM, Karacay H, Govindan SV, Goldenberg DM. Combination radioimmunotherapy and chemoimmunotherapy involving different or the same targets improves therapy of human pancreatic carcinoma xenograft models. Mol Cancer Ther. 2011 Jun;10(6):1072-81. doi: 10.1158/1535-7163.MCT-11-0115. Epub 2011 Apr 5. PMID 21467164
- BACKGROUNDTokh M, Bathini V, Saif MW. First-line treatment of metastatic pancreatic cancer. JOP. 2012 Mar 10;13(2):159-62. PMID 22406590
- BACKGROUNDGold DV, Newsome G, Liu D, Goldenberg DM. Mapping PAM4 (clivatuzumab), a monoclonal antibody in clinical trials for early detection and therapy of pancreatic ductal adenocarcinoma, to MUC5AC mucin. Mol Cancer. 2013 Nov 20;12(1):143. doi: 10.1186/1476-4598-12-143. PMID 24257318
- BACKGROUNDGold DV, Gaedcke J, Ghadimi BM, Goggins M, Hruban RH, Liu M, Newsome G, Goldenberg DM. PAM4 enzyme immunoassay alone and in combination with CA 19-9 for the detection of pancreatic adenocarcinoma. Cancer. 2013 Feb 1;119(3):522-8. doi: 10.1002/cncr.27762. Epub 2012 Aug 16. PMID 22898932